© 2009 by the American College of Gastroenterology The American Journal of GASTROENTEROLOGY

nature publishing group ABSTRACTS S1

ESOPHAGUS1

High Resolution Esophageal Mamometry: Relationship of Hiatal Hernia in Patients with Atypical Chest Pain and Gastroesophageal Refl uxGregg Valenzuela, MD, Donna Dickinson, RN. Riverside Health System, Tappahannock, VA.

Purpose: Gastroesophageal refl ux has been reported to be associated with a high prevalence of hiatal hernia. Recent availability of high-resolution three-dimensional imaging of the esophagus to study motility has provided a new way to study this physiology.Methods: Th irty-fi ve consecutive patients with complaints of gastroesophageal refl ux and atypical chest pain were studied with high-resolution esophageal motil-ity using the 36 circumferential sensor solid-state catheter (MANOSCAN 360, Sierra Scientifi c Instruments). A standard protocol was used in all patients and 10 wet swallows were analyzed. All patients had topical intranasal analgesia applied with 10 cc of viscous lidocaine before placement of the manometric catheter.Results: Th e mean lower esophageal sphincter (LES) basal pressure was low at 7.9 mm Hg (normal 10-45 mm Hg). Th e mean LES length was normal at 3.4 centimeters. Hiatal hernias were found in only 3/35 patients. Other fi ndings were: Achalasia 2, Hypertensive LES 2, Nutcrackers 1, Scleroderma esophagus 2, Hypotensive LES 26, Diff use esophageal spasm (>20% simultaneous) 14, Ineff ective esophageal motility (>30% ineff ective) 4, normal 2. Findings add up to more than 35 as some patients had more than one diagnosis.Conclusion: Hiatal hernias were rarely found, 3/35, in patients with symp-toms of atypical chest pain and gastroesophageal refl ux. Th is may be because studies with this catheter allows testing with less disturbance of the esophageal physiology as compared to that seen with radiographic or endoscopic studies which have comprised many of the previous reports indicating a high preva-lence of hiatal hernia associated with gastroesophageal refl ux.

2

Duodenal Eosinophilia in Eosinophilic EsophagitisSaroj Bangaru, MD, Ikuo Hirano, MD, Purabi Dhakras, MD, Guang-Yu Yang, MD, PhD. Gastroenterology, Northwestern Memorial Hospital, Chicago, IL.

Purpose: Eosinophils are present throughout the GI tract with the exception of the esophagus. Th e signifi cance of increased eosinophils in the duodenum is not well understood. Duodenal eosinophilia has been seen in dyspepsia but has not been well studied in eosinophilic esophagitis (EoE). Th e aim of this study is to characterize gastric and duodenal eosinophilia in patients with EoE and non-ulcer dyspepsia (NUD). Our hypothesis is that there is increased duodenal eosinophilia in EoE and NUD compared to control patients. We also hypoth-esize that there is no diff erence in gastric eosinophilia among these groups.Methods: A retrospective chart review was done to gather information on baseline characteristics. Gastric and duodenal biopsy histopathology was prospectively reviewed. Eosinophils were counted in fi ve high power fi elds. Th e mean eosinophil count was calculated for each patient. Each group had about thirty patients. Th e NUD patients met Rome III criteria. A small group of eosinophilic gastroenteritis (EG) patients were also compared to controls. Patients with malignancies, hypereosinophilic syndrome, infl ammatory bowel disease, infections, H. pylori, myeloproliferative disease, collagen vascular dis-ease, celiac disease and alcohol abuse were excluded from the study.Results: Duodenal eosinophil counts for EoE patients ranged from 1 to 54, with a mean of 8. Ranges in the other three groups were smaller. Th e median duodenal eosinophil counts for EoE (5.5) and NUD (4.3) were higher than the control group (4), p<0.05. Th ere was no statistically signifi cant diff erence between the median duodenal eosinophil counts of EG (4.8) and controls (4). Th e median gastric eosinophil count for EG (28.7) was higher than the control

group (4.2), p<0.05. Th ere was no statistically signifi cant diff erence between the median gastric eosinophil counts of EoE patients (4.4), NUD patients (3) and control patients (4.2).Conclusion: Patients with EoE and NUD have increased duodenal eosino-philia compared to control patients. Th e median eosinophil count of the EG group was higher than the control group and NUD group. However, there was probably no statistically signifi cant diff erence between EG and control patients due to the relatively small number of EG patients. Th e similarity of gastric eosinophil counts among the EoE, NUD and control patients is con-sistent with prior studies. Th e high gastric eosinophil count of the EG group is consistent with their diagnosis. Th e median eosinophil counts in this study may be lower than prior studies due to higher percentage of female patients, younger age, and exclusion of patients with H. pylori. Duodenal eosinophilia in EoE is a novel fi nding and additional studies will need to done.

3

Barium Esophagram Remains a Highly Sensitive Screening Examination for the Diagnosis of AchalasiaPhil Hart, MD,1 Dawn Francis, MD, MHS2. 1. Department of Internal Medicine, Mayo School of Graduate Medical Education, Rochester, MN; 2. Miles and Shirley Fiterman Center for Digestive Diseases, Mayo Clinic, Rochester, MN.

Purpose: Th e diagnostic evaluation of achalasia involves multiple modali-ties including clinical history, radiography, esophageal manometry, and endoscopy. Many consider barium esophagram the fi rst diagnostic step to be pursued. Th e utility of this study as an eff ective initial test depends on the sen-sitivity of its fi ndings. Our primary aim is to evaluate the sensitivity of barium esophagram to detect abnormalities associated with achalasia.Methods: Esophageal manometry studies from January 2006—November 2007 were retrospectively reviewed for evidence of aperistalsis by an experi-enced clinician. All patients demonstrating manometric criteria of achalasia and carrying a clinical diagnosis of achalasia by a clinician independent of this study were selected for further review. All radiology reports were reviewed. Patients with esophagrams performed at outside centers were not included to ensure standardization of images and interpretation.Results: Seventy-one patients of 962 undergoing esophageal manometry had both the manometric and clinical diagnosis of achalasia. Twenty-seven patients did not have an esophagram performed at our institution, so a total of 44 studies were reviewed. Abnormal or absent primary peristalsis was detected on 37 studies (84%), while esophageal dilation was detected on 32 studies (73%) and GE junction narrowing on 22 studies (50%). Excluding patients who had previously undergone myotomy, botulinum toxin injections, or dilations, GE junction narrowing was detected on 13 of 20 (65%) studies. At least one of the characteristic fi ndings was detected on each of the studies, while only 13 patients (30%) had all three features present.Conclusion: While no one radiographic fi nding in isolation was extremely sensitive, at least one characteristic abnormality was present in each patient with achalasia evaluated in this series. Since the presence of even one of the radiographic abnormalities of achalasia is suffi cient to raise suspicion for this diagnosis and necessitate additional investigation, these fi ndings are clinically signifi cant and demonstrate barium esophagram remains a highly sensitive screening examination for the diagnosis of achalasia.

4

Eosinophilic Esophagitis in Adults Lacks Seasonal CorrelationMartha Karakelides, MD,1 Jana Kopacova, Medical Student,1 Felicity Enders, PhD,1 Ross Dierkhising, MSc,1 Nicholas Talley, MD, PhD,2 Catherine Weiler, MD, PhD,1 Jeff rey Alexander, MD, FACG1. 1. Mayo Clinic, Rochester, MN; 2. Mayo Clinic, Jacksonville, FL.

Purpose: Th e role of aeroallergens in the pathogenesis of eosinophilic esoph-agitis (EoE) is not clear. Recent case reports and small cohort studies have

Am J Gastroenterol 2009; 104:S1–S15; doi:10.1038/ajg.2009.492

The American Journal of GASTROENTEROLOGY VOLUME 104 | SUPPLEMENT 3 | OCTOBER 2009 www.amjgastro.com

AbstractsS2

shown a seasonal pattern in new diagnoses of EoE in pediatric and adult patients suggesting the possibility that seasonal allergic reactions may play a role in the pathogenesis of EoE. In this study, we evaluated a large cohort of patients with esophageal eosinophilia and dysphagia to clarify the seasonality of presentation.Methods: Th e Mayo Clinic electronic database was reviewed to identify adult patients who resided in MN, WI, or IA undergoing EGD with dysphagia. Th e month of diagnosis was used as a surrogate marker for activity of disease. GERD patients were not excluded from this analysis. Th e Watson-Williams circular test was used to detect diff erences in the mean presentation month between binary patient groups.Results: Th e diagnosis of EoE was made in 372 patients. Th ese included 270 (73%) men and the mean age was 41.9 yrs (range 18-85). Th e range of eosinophils was 10 to 300 per HPF (mean 39.5). Endoscopic fi ndings included rings (58%), furrow (30%), white spots (2%), fragility (3%), and a normal appearance (26%). Th ere was no time of year where presentation was more frequent (p>0.9). Th e results are displayed in Table 1. Th e mean month was not signifi cantly diff erent between those with and without high (>24) eosinophil counts. Th ere was no diff erence for patients with any positive allergen-specifi c IgE tests for tree, grass, mold or weed allergens compared to those with all negative tests. Patients with greater than four positive aeroaller-gen-specifi c IgE tests also did not have a diff erent mean presentation month (p=0.33). Moreover, patients with or without GERD symptoms and/or ero-sive esophagitis showed no diff erence in mean presentation month (p=0.42).Conclusion: Adults with dysphagia and esophageal eosinophilia do not develop symptoms in a seasonal pattern. Th e role of aeroallergens in adult EoE needs to be further evaluated.

5

Disease Progression in Non-Erosive Refl ux Disease (NERD): A Follow-up Report in an Asian PopulationChien-Lin Chen, MD, PhD, FACG, Chih-Hsun Yi, MD, Tso-Tsai Liu, MD. Tzu Chi University Hospital, Hualien, Taiwan.

Purpose: We investigated the 5-year clinical course in a cohort of patients with typical refl ux symptoms and negative endoscopy. We also investigated whether baseline pathological esophageal acid exposure would infl uence the outcome of the clinical course.Methods: All patients had a 24-H pH evaluation at baseline. Prospective follow-up was conducted in this group of patients with non-erosive refl ux disease (NERD) for at least 5 years aft er initial evaluation with esophageal pH monitoring and upper gastrointestinal endoscopy. Patients were asked to complete a symptomatic questionnaire.

Results: Within the last year of follow-up, refl ux symptoms occurred in twenty-seven of the thirty patients (90%) whenever active therapy was discon-tinued. Twenty-fi ve of twenty-seven symptomatic patients (93%) were on acid suppression therapy. Th e majority of our patients (70%) remained unchanged in endoscopic status over 5 years. Th e progression to erosive esophagitis occurred in 4 patients with LA A (13%), 3 patients with LA B (10%), and 2 patients with LA C (7%). Th e presence of initial pathological acid exposure did not alter the presence of refl ux symptoms or the use of acid suppression therapy over 5 years. Disease progression to erosive esophagitis occurred more frequently in patients with pathological acid exposure than those without pathological acid exposure (P=0.025).Conclusion: Most NERD patients still have symptoms and require acid sup-pression therapy 5 years aft er their initial diagnosis. Initial pathological acid exposure does not infl uence the use of acid suppression or symptom presen-tation; however, it does infl uence the progression of NERD within 5 years of follow-up.

6

Esomeprazole Dose and Symptom Resolution in Patients with Gastroesophageal Refl ux Disease (GERD): Is Th ere a Ceiling Eff ect?

2009 Presidential PosterMarta Illueca, MD,1 Sherry Liu, PhD,1 Roy Orlando, MD2. 1. AstraZeneca LP, Wilmington, DE; 2. University of North Carolina, Chapel Hill, NC.

Purpose: To determine the relationship between esomeprazole dose and symptom resolution in patients with symptomatic GERD, prior response to antacids/acid suppression therapy, and a positive acid perfusion test.Methods: Th is randomized, double-blind, proof-of-concept study (D9612L00106, NCT00206024) included patients aged 18-75 yrs with a history of both heartburn for ≥6 mo and symptomatic response to antacids/acid sup-pression therapy. Patients recorded heartburn symptoms during a 2-wk run-in period using an electronic diary. At the end of the run-in period, those who had moderate to severe heartburn ≥3 d/wk and who had not used acid suppres-sion therapy had an acid perfusion test. Th ose with a positive acid perfusion test were then randomized to 1 of 3 dosing regimens for 4 wk: esomeprazole 20 or 40 mg daily or 40 mg twice daily. Primary effi cacy measures included proportion of patients with sustained heartburn resolution for 7 d and heart-burn relief during week 4 and secondary measures included heartburn-free days/nights.Results: Of the 368 patients in the intention-to-treat population, most were white women; mean age was 45 y, and mean body mass index was 29.8 kg/m2. The proportion of patients with sustained heartburn resolu-tion was similar for all 3 groups as was heartburn relief during week 4 (Table). Nocturnal heartburn control in the esomeprazole 40 mg twice daily group showed improvement compared with the other 2 groups but was not statistically significant.Conclusion: Treatment with all esomeprazole doses provided reasonable and similar rates of sustained heartburn relief, suggesting a plateau eff ect in terms of clinical response to acid suppression with proton pump inhibitor (PPI) therapy. Despite an attempt to enrich the study population through the use of history of response to acid suppression and positive acid perfusion test, the study did not show an increased symptomatic response to increased doses of drug. However, all doses of esomeprazole did provide reasonable and simi-lar rates of sustained heartburn relief, suggesting a plateau eff ect in terms of the clinical response to acid suppression with PPI therapy. Potential areas of future research include studying the eff ect of varying PPI dose and timing of administration on acid control in individual patients and assessing the poten-tial value of managing other components of GERD besides acid control.Disclosure: Dr Orlando has or has had in the recent past fi nancial relationships (consulting, lecture bureau, research support, stock ownership) with Amicus Th erapeutics, AstraZeneca LP, Boston Scientifi c, Merck, Novartis, Pfi zer, Procter & Gamble, Santarus, and Sirna. Drs Illueca and Liu are employees of AstraZeneca LP.Th is research was supported by an industry grant from Study funded by AstraZeneca LP.

Table 1 . Variation in the mean time of year by patient characteristic

Characteristic Patients with

characteristic N ( % ) Patients without the

characteristic N p value

Heartburn 127 (55) 104 0.93

Regurgitation 63 (43) 85 0.62

Heartburn or regurgitation or erosive esophagitis

171 (76) 54 0.66

History of atopic disease 130 (37) 10 0.96

Food allergies 44 (61) 28 0.31

Any ( + ) aeroallergen 48 (70) 21 0.83

Any ( + ) allergen (aeroal-lergen or food)

44 (61) 28 0.31

>24 eosinophils / high power fi eld

253 (68) 119 0.68

© 2009 by the American College of Gastroenterology The American Journal of GASTROENTEROLOGY

Abstracts S3

7

Th e Impact of Age on Esophageal Function and Quality of Life in Patients with Non-Obstructive DysphagiaStephanie Hansel, MD, MS,1 Michael Crowell, PhD, FACG,2 Sudip Ghosh, PhD,3 George Burdick, MD,2 H. Jae Kim, MD,2 John DiBaise, MD, FACG,2 Virender Sharma, MD, FACG2. 1. Mayo Clinic, Rochester, MN; 2. Mayo Clinic, Scottsdale, AZ; 3. University of Cincinnati, Cincinnati, OH.

Purpose: Non-obstructive dysphagia (NOD) refers to the symptoms of dyspha-gia in patients without known stricturing disease. Th e exact etiology of NOD is unknown. We hypothesized that older and younger patients may present diff er-ently clinically, and they might have diff erent fi ndings on esophageal manometry.Methods: Consecutive patients presenting for esophageal manometry with a primary indication of esophageal dysphagia were evaluated (n=141). Patients with evidence of mechanical obstruction including stricture, achalasia, severe esophagitis, or scleroderma on review of medical record, EGD, barium esoph-agram, or previous manometry were excluded. Th e remaining patients (n=84) were divided into two groups based on age (Younger (Y): ≤69 yrs.; Older (O): ≥70 yrs). All patients completed solid-state, high-resolution esophageal manometry (HRM). Th e study was completed in a semi-supine position aft er an overnight fast. Th e protocol included a baseline resting period to assess basal sphincter pressure, 10 water swallows of 5 ml each, and fi ve solid swal-lows (cracker) in the same session. Prior to the HRM patient were interviewed regarding specifi c symptoms and completed the SF-12v2 to assess quality of life and the swallowing diffi culty index (SDI). Data were evaluated using Student’s t-test, Mann-Whitney U, chi-square, or logistic regression with signifi cance set at p < 0.05. Data are presented as Mean ± s.d.Results: Th e groups diff ered in age (Y=54±12 vs. O=77±5 yrs), but did not diff er signifi cantly on other demographic characteristics. Th e patient reported severity of dysphagia was similar between the two groups. Younger patients reported heartburn (72% vs. 36%), regurgitation (70% vs. 48%), nausea (57% vs. 13%), early satiety (59% vs. 26%), and belching (47% vs. 23%) more fre-quently than older patients (p<0.05). Mean contraction wave amplitude was lower in older vs. younger NOD patients (105.5±48.7 vs. 82.5±44.7 mmHg, p<0.05), primarily due to lower amplitudes in the distal 3-5 cm above the LES (113.3±61.8 vs. 80.0±42.3 mmHg, p<0.05). Older NOD patients had lower LES basal tone and higher residual pressures, but these did not reach statisti-cal signifi cance. Ineff ective esophageal motility tended to be diagnosed more frequently in older NOD patients (19% vs. 32%, p=0.19). Th e patient-reported severity of swallowing diffi culty was similar between the two groups, but Y patients reported more swallow-related interference with quality of life.Conclusion: Topographical mapping of esophageal motor function using HRM can increase the diagnostic yield in patients with dysphagia. Older NOD patients tend towards decreased esophageal motility, while younger NOD patients exhibit normal motor function and increased dyspeptic symptoms.

8

Etiologies and Treatment Outcomes in Patients with Oropharyngeal DysphagiaCharles Randall, MD,1 Jackie Rellas, MD,3 Carlo Taboada, MD,1 Russell Havranek, MD,2 Franz Zurita, MD,2 David Stump, MD, FACG,2 Christopher Fincke, MD1. 1. Research, Gastroenterology Research of San Antonio, San Antonio, TX; 2. Gastroenterology Clinic of San Antonio, San Antonio, TX; 3. University of Texas Health Science Center at San Antonio, San Antonio, TX.

Purpose: Th ough gastroenterologists are specifi cally trained in diagnosing and managing esophageal dysphagia, we are asked to care for patients with oropha-ryngeal dysphagia as well. Th is paper outlines diagnoses, stratifi es them by age group and provides long-term follow-up.Methods: 638 patients were referred to our tertiary care center for dysphagia. Aft er eliminating 555 patients with esophageal dysphagia and 38 patients with a presenting diagnosis of Amyotrophic Lateral Sclerosis, we had 45 patients to follow. We did not include patients with oropharyngeal cancers or radiation strictures in this study. Patients were stratifi ed by age and diagnoses that were divided among functional (globus histericus—GH); laryngeopharyngeal refl ux (LPR); neurological disorders (Parkinson’s, MS, CVA, etc.), cricopharyngeal disorders (cricopharyngeal hypertrophy and achalasia). Diagnoses were made with necessary manometry, radiological and endoscopic studies. Treatments for GH included pre-prandial anticholinergics with or without adjunctive tri-cyclics; LPR with appropriate PPI therapy given BID; Neurological disorders (ND) with speech pathology; and cricopharyngeal disorders (CPD) with dila-tion techniques. None of the Zenker’s patients opted for surgery.Results: Th e age stratifi cation is summarized in the table below. Treatment for the GH group was successful in resolving symptoms >90% of the time. Dysphagia also resolved in the LPR group >90% of the time. Cricopharyngeal dysphagia had a 100% success rate aft er dilation but 27.3% required a 2nd dilation within 1 year. 50% of the neurological patients improved with speech pathology but 20% required PEG due to progressive symptoms. All patients had a mean follow-up time of 1 year.Conclusion: 1. GH is most prevalent in patients under 60 years of age. 2. LPR with exception of the youngest group can be seen through out the range of ages. 3. As expected, ND and CPD increase with age and were not seen in patients <50. 4. Treatments were highly successful in all groups with exception of ND. No data was available for ZD.

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Etiologies of Esophageal Dysphagia Vary Among Diff erent Age GroupsCharles Randall, MD,1 Jackie Rellas, MD,3 Carlo Taboada, MD,1 Russell Havranek, MD,2 David Stump, MD, FACG,2 Franz Zurita, MD,2 Christopher Fincke, MD1. 1. Research, Gastroenterology Research of San Antonio, San Antonio, TX; 2. Gastroenterology Clinic of San Antonio, San Antonio, TX; 3. University of Texas Health Science Center at San Antonio, San Antonio, TX.

Purpose: Dysphagia is a common problem presenting to gastroenterologists. Th e purpose of this study was to determine if certain types of dysphagia were

[6] Effi cacy of esomeprazole in the treatment of acid-related heartburn

Effi cacy variable Esomeprazole

20 mg ( N =121) Esomeprazole

40 mg ( N =121)

Esomeprazole 40 mg twice daily

( N =126)

Sustained HB resolution rate during week 4, n / N ( % )

47 / 98 (48.0) 40 / 91 (44.0) 41 / 99 (41.4)

HB relief rate during week 4, n / N ( % )

58 / 98 (59.2) 47 / 91 (51.7) 53 / 99 (53.5)

Cumulative daily sustained HB resolution rate at day 28, n / N ( % )

27 / 43 (62.8) 26 / 50 (52.0) 31 / 50 (62.0)

Mean (s.d.) HB-free days during week 4, %

n =120,66.5 (39.1) n =112,62.4 (40.5) n =121,67.8 (37.7)

Mean (s.d.) HB-free nights during week 4, %

n =120,80.8 (32.9) n =112,78.0 (33.9) n =121,88.2 (24.2)

Last observation carried forward approach was necessary because of the limited number of patients with data for day 28. HB, heartburn; s.d., standard deviation.

Causes of oropharyngeal dysphasia

Age group GH LPR ND ZD CPD

< 30 100 % — — — —

30 – 39 33 % 67 % — — —

40 – 49 25 % 50 % — 25 % —

50 – 59 45.5 % 9.1 % 18.1 % 9.1 % 18.2 %

60 – 69 16.7 % — 33.3 % — 50 %

70 – 79 8.3 % 8.4 % 25 % 8.3 % 50 %

80 – 89 — — 25 % — 75 %

90 – 99 — 25 % 50 % — 25 %

GH, globus histericus; LPR, laryngeal pharyngeal disease; ND, neurological disorders ZD, Zenker’s diverticulum; CPD, crycopharyngeal disorders.

The American Journal of GASTROENTEROLOGY VOLUME 104 | SUPPLEMENT 3 | OCTOBER 2009 www.amjgastro.com

AbstractsS4

more prevalent in diff erent age groups. Th is knowledge will serve the clini-cian to provide a focused evaluation when diagnosing and planning treatment strategies for the patients.Methods: Patients were stratifi ed by age based on decade of life. Diagnoses included obstructive disorders (Schatzki Rings, strictures and tumors); Erosive (Refl ux) Esophagitis, Eosinophilic Esophagitis, motility disorders, functional disorders and miscellaneous (infections, Sjogrëns, pill-induced, Scleroderma, etc.).Results: Over 600 patients were referred to our tertiary center as diagnostic dilemmas or for treatment of dysphagia. We eliminated patients with oropha-ryngeal dysphagia and those with radiation strictures and anastomotic stric-tures. Our fi nal patient population was 488. Th e Table above summarizes the fi ndings.Conclusion: 1. SR’s are relatively common in all age groups but most prevalent in groups over 50. 2. STX are relatively uncommon in patients <40 but increase with each decade of life. 3. Cancers were seen with similar frequency in ages 40-79. 4. EE causes dysphagia with greatest frequency in ages 30-59. 5. EOS is most common in patients <39. 6. IE was seen throughout all groups but is more common in patients <50. 7. Motility disorders were the leading cause of dysphagia in all age groups. a. <50 mixed disorders, achalasia, primary motil-ity disorders. b. >60 Presbyesophagus was most common. c. 50-59, all of the above.

10

Effi cacy of Combined Treatment on Eosinophilic EsophagitisNa Li, MD, PhD, Bryan Green, MD, Kostas Sideridis, DO, FACG. Long Island Jewish Medical Center, New Hyde Park, NY.

Purpose: Eosinophilic esophagitis (EoE) is a rare disease involving eosinophil infi ltration of the esophageal mucosa. Treatment with an anti-infl ammatory agent or a proton pump inhibitor has been studied with clinical success, yet many patients relapse shortly aft er completion of the treatment. We evaluated a combination regimen for symptomatic relief of patients with EoE.Methods: Eight patients from a single, adult gastroenterology unit with EoE were identifi ed. Diagnosis was made by endoscopic and histologic fi ndings. All the patients received 3 months treatment with combined pantoprazole 40 mg, montelukast 10mg and fl uticasone 2 puff s.Results: Seven men and one woman with mean age of 38 years were evaluated in our study. Seven patients presented with food impaction. Five patients had typical ringed-appearing esophagus. All patients had eosinophilic infi ltration histologically. No recurrent symptoms were identifi ed in these patients with a follow-up period ranging from 2 to 24 months.Conclusion: EoE aff ects predominantly middle-aged men with symptom-atic food impactions. Th e regimen of combined pantopranzole, montelukast and fl uticasone appears to be eff ective in treating EoE and reducing recurrent symptoms.

11

Modifi cation of the Standard Esophageal Dilation Technique Improves Effi cacy in the Treatment of Schatzki Rings and StricturesCharles Randall, MD,1 Jackie Rellas, MD,3 Carlo Taboada, MD,1 Carleigh Jacobs, RN,2 Sharon Asgari, RN2. 1. Research, Gastroenterology Research of San Antonio, San Antonio, TX; 2. Gastroenterology Clinic of San Antonio, San Antonio, TX; 3. University of Texas Health Science Center at San Antonio, San Antonio, TX.

Purpose: Historically, Schatzki Rings and strictures at the gastroesophageal junction have been managed with a variety of techniques that include Maloney Bouigenage, Savory dilation and balloon dilation. Balloon dilation has become the preferred technique by experienced endoscopists with or without adjuvant Endoincision. Some dilation procedures result in a single deep tear that pre-vents further dilation while allowing the majority of the ring to remain intact. Th is paper describes a modifi cation on the current technique of 3 stage con-trolled radial expansion (CRE) balloon dilatation.Methods: 20 patients (17 with Schatzki Rings and 3 with strictures) had initial dilations that resulted in deep submucosal tears that prevented further dilata-tion. None of the patients had experienced relief of dysphagia from these proce-dures and returned to the endoscopy suites for a second procedure. All patients underwent a second dilation with a Microvasive CRE Balloon® (Boston Scien-tifi c). Rather than dilating at the traditional 3 stages based on measurements in French or millimeters, a modifi ed technique was carried out where balloon pres-sure was increased by 0.5 ATM (stopping at each 0.5 ATM stage for 1 minute).Results: Using the slow dilation technique, all patients averaged 3 adequate tears (range 2-5), without the need to stop prematurely. All patients had a greater per-centage of their ring or stricture disrupted with this technique. 16 patients had an increase in the circumference of the balloon by 9 French and 4 by 6 French as compared to their initial dilation using the traditional technique. Mean follow-up time was 9 months (range 6-18 months). Th e only recurrence was in a patient with Scleroderma Esophagus with refractory Grade D esophagitis.Conclusion: 1) Th e slow dilation techniques improve the end-result in patients experiencing early deep-tears and premature cessation of the procedure. 2) 95% had lasting success and the only failure was a Scleroderma Esophagus with per-sistent esophagitis. 3) All patients had greater ring destruction and future studies may prove the slow dilation method to be the preferred method in all patients.

12

Acquired Benign Tracheo-esophageal Fistula in Diffi cult-to-Wean PatientsPeter Chen, MD, FACG,1 Shwe-Winn Chen, MD,1 Cheng-Yu Wen, MD,1 Yih-Ming Su, MD,1 Fu-Yao Lo, MD,1 Kui-Lin Cheng, MD2. 1. Department of Internal Medicine, Central Medicine Hospital Group, Taipei, Taiwan; 2. Department of Radiology, Ten-Chen Medical Group, Chung-Li, Taiwan.

Purpose: Th e acquired benign tracheo-esophageal fi stula (TEF) in adults is rare. Th e most common cause is a complication of intubation with cuff -related tracheal injury. A total of 205 cases of cuff -related TEF had been reported in

[9] Diagnosis

Age group SR STX TM EE EOS IE MO MISC

< 30 10 % 5 % — 15 % 15 % 20 % 25 % 10 %

30-39 10 % — — 27 % 15 % 22 % 20 % 6 %

40-49 17 % 6 % 6 % 28 % 3 % 17 % 20 % 3 %

50-59 27 % 7 % 2 % 20 % 4 % 9 % 25 % 6 %

60-69 28 % 9.4 % 5.2 % 5.2 % 3.2 % 10.4 % 35.4 % 3.2 %

70-79 21 % 15.6 % 6.4 % 8.3 % — 6.4 % 41.3 % 1 %

80-89 20 % 18.8 % — 4.5 % — 2 % 54.7 % —

90-99 — — — — — — 75 % —

SR, Schatzki Ring; EE, Erosive Esophagitis; MO, Motility; STX, Stricture; TM, Tumor; EOS, Eosinophilic Esophagitis; MISC, Miscellaneous; IE, Irritable Esophagus.

© 2009 by the American College of Gastroenterology The American Journal of GASTROENTEROLOGY

Abstracts S5

the last 46 years. Th e diffi cult-to-wean patients were not reported separately except in one case report. Management of TEF in diffi cult-to-wean patients is diff erent because the usual management is weaning before repair. Th e diagno-sis and outcome may also be diff erent.Methods: TEF was diagnosed on 6 out of 721 diffi cult-to-wean patients admit-ted to 5 respiratory units in our hospital group between October 1, 2006 to September 30, 2008. Th e demographics, the presenting features, diagnostic fi ndings (endoscopy, radiology, including MDCT) and clinical course were reviewed.Results: Th e age of the patients ranged from 75 to 85 years (mean 80.67±3.56 years) with 4 males and 2 females. Th e duration of mechanical ventilation before the diagnosis ranges from 1.08 to 7 years (mean 3.63±2.09 years) with trache-ostomy (TT) in 5 patients and endotracheal tube (ET) in one. Th e presenting features were abdominal distension (6/6), leakage of NG feeding diet from TT (3/6), excessive air from NG tube (3/6), frothy secretions in oral cavity (3/6), bloody materials in NG tube (2/6) and choking on NG feeding (1/6). Esopha-goscopy showed infl ated TT/ET cuff through orifi ce in esophageal wall (6/6). Initial CXR showed pneumonia (5/6), pleural eff usion (1/6). MDCT showed pneumonia (5/6), bronchiectasis (2/6) and pleural eff usion (2/6) and TEF (on virtual esophagoscopy and bronchoscopy) (2/6). All patients were in clinical condition too poor to undergo primary repair. TTs were replaced with ET tube (5/6) and ET was inserted more distally (1/6) to relocate the cuff distal to TEF. Th ree patients underwent jejunostomy for feeding and gastrostomy for decom-pression. All patients died aft er 1 to 12 months aft er the diagnosis (mean 4±4.2 months). Pneumonia with septic shock was the cause of death in all cases.Conclusion: 1) A high index of suspicion is required for diagnosis of TEF in diffi cult-to-wean patients. 2) Th e diagnostic procedure of choice is esophagos-copy 3) Th e prognosis of TEF in diffi cult-to-wean patients is poor and usually died within 1 year of diagnosis.

13

Gastric Biopsy Results From Patients Treated With Dexlansoprazole MR, a Proton Pump Inhibitor with a Dual Delayed Release FormulationMary Bronner, MD,1 M. Claudia Perez, MD,2 Aruna Dabholkar, MD,2 William Palo, MS2. 1. Cleveland Clinic Foundation, Cleveland, OH; 2. Clinical Sciences, Takeda Global Research & Development Center, Inc., Lake Forest, IL.

Purpose: Dexlansoprazole MR (DEX), an enantiomer of lansoprazole, is a PPI that employs novel Dual Delayed Release technology to extend the duration of acid suppression. Th is analysis was performed to identify potential gastric eff ects of DEX.Methods: Gastric biopsies were obtained at baseline and fi nal visit from patients with symptomatic GERD or erosive esophagitis who participated in

1 of several healing, maintenance, or safety studies. Patients were treated for 6 months with DEX or placebo in the maintenance studies and for 12 months with DEX in the safety study. Mucosal biopsies were taken from the gastric antrum and fundus/body (2 from each location). All biopsies were evaluated by expert gastrointestinal subspecialty pathologists at the Cleveland Clinic for H. pylori, active and chronic gastritis, intestinal metaplasia (IM), endocrine cell hyperplasia, reactive gastropathy, and other pathologies. Th e diagnoses were summarized by treatment group and compared with Fisher’s exact test.Results: Final visit biopsies adequate for diagnosis were available for 446 patients receiving DEX 30, 60 or 90 mg and 140 patients receiving placebo in the maintenance trials and for 411 DEX 60 or 90 mg recipients in the safety trial. At baseline, up to half of patients had abnormal biopsy results (antral or fundic), primarily chronic gastritis or reactive gastropathy. At fi nal visit, most patients with normal histology at baseline remained normal (DEX, 78%; pla-cebo, 77%). Chronic gastritis (antral or fundic) was the most common abnor-mality reported in DEX recipients (30-34%) and placebo recipients (33%). Signifi cant diff erences (P≤0.05) were seen in the maintenance trials for antral reactive gastropathy (DEX 90 mg, 9.2%; placebo, 2.3%) and fundic chronic gastritis with H. pylori (DEX 90 mg, 1.0%; placebo, 6.5%). IM (antral or fun-dic) was reported in 2.6%-4.6% of DEX and 4.3% of placebo recipients in the maintenance trials and in 3.8%-4.6% of DEX recipients in the safety trial; all were negative for dysplasia. Endocrine cell hyperplasia, adenocarcinoma and lymphoma were not observed. Rates of worsened and improved diagnoses were similar for all treatment groups in the maintenance and safety trials.Conclusion: No clinically signifi cant or unexpected pathologic fi ndings were observed in gastric biopsies of 446 total patients treated with DEX compared with 140 placebo patients. In particular, no endocrine cell hyperplasia or carci-noid tumors developed. Changes in histological diagnoses were unremarkable and were consistent with those seen with other PPIs.Disclosure: Mary Bronner, MD - no fi nancial relationship. M. Claudia Perez, William Palo, and Aruna Dabholkar are employees of Takeda Global Research & Development Center, Inc., Deerfi eld, IL.

14

Arbaclofen Placarbil Monotherapy Improves Sleep Quality in Patients Who Have Previously Responded to a PPINimish Vakil, MD,1 Jacob Huff , MD,2 Drew Jones, MD,2 Amy Bian, ME,2 David Stamler, MD2. 1. University of Wisconsin School of Medicine and Public Health, Milwaukee, WI; 2. XenoPort, Santa Clara, CA.

Purpose: Arbaclofen Placarbil (AP) is a novel Transported Prodrug of the refl ux inhibitor R-baclofen. Th e eff ects of AP on sleep-related symptoms were evaluated as part of a Phase 2 study of AP as treatment for patients with gastro-esophageal refl ux disease (GERD).Methods: In a double-blind, placebo-controlled study of patients with non-erosive GERD (including LA-A erosive esophagitis), randomization to treat-ment was stratifi ed based on a history of at least partial symptom response to proton pump inhibitor (PPI) therapy (PPI-responsive, n=98) or no history of taking PPIs (PPI-naïve, n=58). Patients discontinued previous GERD therapy except rescue antacids during a 2-week washout, and then were randomized to receive 20 mg QD, 40 mg QD, 60 mg QD, 30 mg BID or placebo for 4 weeks. Patients used an electronic diary to record heartburn (Hb) and regurgitation (Rg) episodes, awakenings during the night due to GERD symptoms, and visual analog scale (VAS) sleep measures from a modifi ed Pittsburgh Sleep Diary. Th e Epworth Sleepiness Scale was used to assess daytime sleepiness.Results: For PPI-responsive patients, sleep quality improved signifi cantly from baseline to Week 4 for AP at 40 mg QD, 60 mg QD and 30 mg BID com-pared with placebo (P<0.05). Th ere were no signifi cant diff erences between AP and placebo observed for change in alertness or daytime sleepiness scores. At week 4 compared with baseline, there was a non-signifi cant trend toward reduced awakenings per week from Hb or Rg at all doses compared with placebo. Th e percentages of PPI-responsive patients with complete relief of Hb and Rg at week 4 were greater for AP compared with placebo. No sig-nifi cant diff erences in effi cacy endpoints were seen in PPI-naïve patients or in the primary analysis of all patients. Only data for PPI-responsive patients are presented (Table).

Esophagoscopic fi nding.

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Conclusion: AP signifi cantly improves sleep quality in PPI-responsive patients possibly by reducing awakenings due to Hb or Rg.Disclosure: Dr Vakil: Consultant, Advisory Committe Member, and Grant/Research Support from XenoPort, Dr Huff : Employee, XenoPort, Ms. Bian - Employee, Xeno-Port, Dr Jones -Employee, XenoPort, Dr Stamler: Employee, XenoPort.Th is research was supported by an industry grant from XenoPort, Inc.

15

Botulinum Toxin (BoTox) Provides Lasting Symptomatic Benefi t in Non-Achalasia Dysphagia Syndromes with Incomplete Lower Esophageal Sphincter Relaxation (LESR): A Survival Analysis ApproachRyan Porter, MD, C. Prakash Gyawali, MD, MRCP. Gastroenterology, Washington University School of Medicine, St. Louis, MO.

Purpose: BoTox injection into the LES treats non-achalasia dysphagia syn-dromes with incomplete LESR, but duration and predictors of response are not fully known. We aimed to identify clinical and esophageal motor characteris-tics predicting response, and compare duration of effi cacy of a single BoTox injection with similarly treated achalasia patients.Methods: Subjects with evidence of incomplete LESR on high resolution manometry (HRM) treated with BoTox injection were identifi ed. Subjects des-ignated symptom frequency and severity on a 5-point Likert scale, and global esophageal symptomatic state on a 10 mm visual analog scale (VAS) at HRM. Incomplete symptom recording, prior esophageal surgery, and achalasia were exclusion criteria. Symptom resolution for 6 mo was a primary end point, and repeat BoTox injection or symptom recurrence were secondary end points. Univariate and multivariate analysis were performed to identify predictors of response. Duration of response was compared using survival curves to simi-larly treated achalasia subjects.Results: 36 subjects (59±2.2 yr, 19F/17M) fulfi lled study criteria. Presenting symptoms included dysphagia to solids (72.2%), to liquids (63.9%) regurgita-tion (63.9%), chest pain (44.4%) and heartburn (61.1%). Global symptoms were rated 5.9±0.5 on VAS. On HRM, all had elevated trans-LES pressure gradients (mean 13.3±1.4 mmHg), and 66.7% had esophageal body spastic features. Symptom resolution for >6 mo was seen in 58.3%, with a mean response of 12.8±2.3 mo (range 1.2-59.0 mo). Short (<6 mo) response was associated with younger age (53±3.5 vs. 64±2.5 yr, p<0.02), higher chest pain scores (p=0.003), and esophageal body spastic features (p=0.04). On multivariate logistic regres-sion with backward elimination, chest pain, younger age and contraction ampli-tudes >180 mmHg independently predicted <6 mo response (p<0.05 for each). On survival analysis, response extended to 1 yr in 54.8%, 1.5 yr in 49.8% and 2 yr in 16.8% (fi gure), and was statistically similar to that reported by 42 achala-sia subjects (59±3.2 yr, 24F/18M) treated with BoTox (p=ns).Conclusion: BoTox can provide lasting symptom relief in non-achalasia dys-phagia syndromes with incomplete LESR, and results approximate that seen

in achalasia. Prominent perceptive symptoms and nonspecifi c spastic features may predict shorter response.

16

Demographic and Baseline Characteristics of GERD Patients Based on Data From the Dexlansoprazole MR Clinical Trial Program Relative to Earlier Lansoprazole TrialsDavid Peura, MD, MACG,1 M. Claudia Perez, MD,2 Betsy Pilmer, RN, BSN,2 Aruna Dabholkar, MD,2 Cong Han, PhD2. 1. Division of Gastroenterology & Hepatology, University of Virginia Health Sciences Center, Charlottesville, VA; 2. Takeda Global Research & Development Center, Inc., Lake Forest, IL.

Purpose: To assess whether baseline characteristics of subjects participating in clinical studies of GERD treatments have changed over time.Methods: Th is is a retrospective analysis of demographic and baseline char-acteristics of patients enrolled in Phase 3 prospective clinical trials for dex-lansoprazole MR (DEX) that began in 2005. Subjects underwent endoscopy before randomization into symptomatic nonerosive GERD (NERD) or erosive esophagitis (EE) healing trials, which were targeted to recruit about 30% of patients with Grades C and D EE. For comparison, data are presented from the lansoprazole (LAN) clinical trial program, which began in 1987, to assess any shift in the epidemiology of GERD over the intervening 18 years.Results: DEX pivotal studies enrolled 5947 US and ex-US patients (EE, n=4092; NERD, n=1855). LAN trials before approval included 2752 evaluable US patients from 1988−1994 (EE, n=1737) and 1995−1997 (NERD, n=1015); an additional 3510 EE patients participated in a 1999 trial. NERD patients tend to be female, a trend that appears to be accelerating (LAN studies, 58%; DEX studies, 71%, Table). Over time, alcohol use seems to be rising. More patients had milder EE in the 1999 LAN trial and DEX trials than in earlier LAN trials. Even with the enrichment of LA grade C & D EE patients in DEX trials, the

[14]

Week 4 change from baseline Placebo 20 mg QD 40 mg QD 60 mg QD 30 mg BID

Sleep quality (100 mm VAS), mean (s.d.)

− 0.4 (2.9) 4.9 (2.6) 8.9 (2.6)* 7.4 (2.4)* 7.8 (2.9)*

Awakenings / week due to Hb, mean (s.d.)

− 1.3 (0.4) − 2.2 (0.4) − 1.6 (0.4) − 2.1 (0.4) − 1.8 (0.5)

Awakenings / week due to Rg, mean (s.d.)

− 0.7 (0.4) − 1.7 (0.3) − 1.4 (0.3) − 1.0 (0.3) − 1.6 (0.4)

Alertness on awakening (VAS), mean (s.d.)

0.8 (3.3) 2.4 (3.0) 4.8 (3.0) 3.4 (2.8) 0.3 (3.3)

Epworth sleepiness scale, mean (s.d.)

− 1.0 (0.9) − 0.3 (0.8) 0.9 (0.8) − 0.3 (0.8) 0.8 (0.9)

Complete relief of Hb 6 % 21 % 28 % 30 % 50 % *

Complete relief of Rg 12 % 53 % * 35 % 41 % 47 %

* P < 0.05 for AP compared with placebo.

© 2009 by the American College of Gastroenterology The American Journal of GASTROENTEROLOGY

Abstracts S7

distribution of severity appears similar between the DEX and the 1999 LAN trial.Conclusion: Th e demography of GERD study subjects has remained fairly stable over time. It appears that patients are now presenting with less severe EE. Diff erences in grading systems and more widespread use of PPIs may be infl uencing this apparent trend. Sponsored by Takeda Global Research & Development Center, Inc, Deerfi eld, IL, USA.Disclosure: David A. Peura, MD, has served as a speaker, consultant, and an advisory board member for Takeda Global Research & Development Center, Inc. (TAP Pharmaceutical Products Inc. is now a part of Takeda Global Research & Development Center, Inc.); speaker for Astra Zeneca and Santarus. M. Clau-dia Perez, MD, Betsy Pilmer, RN, BSN, Aruna H. Dabholkar, MD, and Cong Han, PhD are employees of Takeda Global Research & Development Center, Inc., Deerfi eld, IL.

17

Esophageal Motility in Amyotrophic Lateral Sclerosis Patients Requiring Percutaneous Endoscopic Gastrostomy TubeMimi Lin, MD, Catherine Madison, MD, William Snape, MD. California Pacifi c Medical Center, San Francisco, CA.

Purpose: To investigate pharyngoesophageal motility in Amyotrophic Lateral Sclerosis (ALS) patient with dysphagia referred for percutaneous endoscopic gastrostomy (PEG) tube placement using high-resolution esophageal manom-etry.Methods: 11 ALS patients referred from the ALS clinic for PEG placement underwent one-time placement of high-resolution solid state esophageal manometry catheter prior to PEG placement. Standard manometric measure-ments were taken according to protocol with 10 swallows of tap water; data was recorded and analyzed with Sierra Scientifi c Instrument’s ManoScan™ Motility Visualization System. Manometric measurements were analyzed with Sierra Scientifi c Instrument’s ManoScan™ Motility Visualization System.Results: Th e average time from the time of diagnosis to PEG placement was 12 months. Th e average median intrabolus pressure (mIBP) was signifi cantly elevated at 49.5±4.84 mmHg compared with 15.2±1.14 mmHg in normal (p=0.0001). Th e deglutative sphincter resistance (DSR) was 43.9±6.28 mmHg/s compared with 21.6±8.81mmHg/s in controls (p=0.02). Th e mean upper esophageal sphincter (UES) relaxation interval in ALS patients was 1.41±0.26 seconds, normal subjects had 0.72±0.04 seconds (p=0.07). Th e mean peak pharyngeal pressure was 195.3±28.73 mmHg in ALS patients and 265.9±43.13 mmHg in controlled (p=0.18). Post-deglutative refl ex hypertension of UES in ALS patients was markedly decreased.Conclusion: Compared with the normal controls, the ALS patients had several UES abnormalities on manometry. Th e elevated median intrabolus pressure as well as DSR suggested decreased compliance of UES. Along with decreased pressure in the post-deglutative refl ex, these abnormalities could contribute to patient’s symptom of dysphagia. Future study will be directed to correlate the severity of dysphagia with manometric measurements.

18

Th e Eff ect of Acid Suppression Th erapy on the Natural History of Barrett EsophagusArchana Patel, MD, Mark Friedman, MD, FACG, Sheetal Sharma, MD, FACG, Seth Richter, MD. Gastroenterology, Albany Medical College, Albany, NY.

Purpose: To examine the natural history of Barrett esophagus, and to assess whether patients who were treated with acid suppression had regression, pro-gression, or stable disease on subsequent endoscopy.Methods: A retrospective chart review of all patients with documented Barrett esophagus was conducted. Th ose who underwent at least 1 surveillance endos-copy were selected. Th e patient’s date of diagnosis, gender, age, and race were collected. Th e segment length and pathology of BE were also recorded. Pathol-ogy was described as intestinal metaplasia (IM), low grade dysplasia (LGD), high grade dysplasia (HGD) or adenocarcinoma. Th e change in segment length and pathology on subsequent exams were recorded and compared to assess for stable disease, regression, or progression. Pathological stable disease showed no change; regression was defi ned as a downgrade of pathology; progression was defi ned as an advancement of pathology. Variable pathology had both regres-sion and progression of disease during the surveillance period. Length progres-sion and regression were defi ned as changes in segment length.Results: 88 patients with Barrett esophagus were evaluated. Of those, 59 (67%) were men and 29 (33%) were women. 83 (95%) were Caucasian, 3 (3%) were African-American and 2 (2%) identifi ed themselves as other. Th e age range was from 33-80, with a mean age of 54, median age of 53, and mode age of 57. Th e mean duration of surveillance was 3 years. All patients were on a proton pump inhibitor. 57 (65%) patients had no pathological change, 10 (11%) had regression, 6 (7%) had progression; 15 (17%) had variable pathol-ogy during the surveillance period. 58 (66%) patients had a stable segment length, 17 (19%) had segment length regression, and 13 (15%) had segment length progression.Conclusion: Th e chemopreventive role of acid suppression in patients with Barrett esophagus has not yet been established. Two retrospective cohort studies have documented a reduction in dysplasia with PPI use. Other studies have not shown a consistent regression of BE, even in patients with docu-mented normalization of pH by PPI therapy. In our study, 65% of patients had no pathologic change of their disease, despite being on a PPI. Regression and progression of disease were seen in only 11% and 7% respectively. More studies need to be done to evaluate if PPI therapy can alter the natural history of Barrett esophagus.

19

Th e LA Grading System for Esophagitis: Correlation with HistopathologyAlden Kielhorn, MD, Robert Genta, MD, FACG. Caris Diagnostics, Irving, TX.

Purpose: Th e LA System for the endoscopic grading of esophagitis is widely used and considered highly reproducible, but the correlation between LA grades and histopathologic fi ndings has not been evaluated in large, commu-nity-based studies. Th e purpose of this study was to determine: 1) the propor-tion of esophageal biopsies obtained in private practice in which LA Grade is provided; 2) the correlation between stated LA Grade and histopathologic fi ndings; and 3) whether the histologic detection of Barrett’s mucosa is related to the LA grade.Methods: We analyzed data from Caris Diagnostics, a gastrointestinal pathol-ogy practice that receives specimens from private gastroenterologists oper-ating in community-based endoscopy centers in 36 states, DC, and PR. Th e database includes demographic and clinical information, endoscopic fi ndings, site of biopsy origin, and histopathologic interpretation. We extracted data from all patients who underwent an EGD with esophageal biopsies in a 12-month period. Statistical calculations were performed using SigmaStat 3.5. A p value < 0.05 was considered signifi cant.Results: Th ere were esophageal biopsies from 49,480 unique patients (median age 57 years, 0-102; 51.2% women). Th e LA Grade was provided in biopsies from 3,620 patients (7.3%); “esophagitis” was noted in 9,876 (19.9%) additional

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AbstractsS8

patients, but no LA grade was provided. In 14,401 (29.1%) patients, neither esophagitis nor Barrett’s esophagus were described.Conclusion: Th e LA grade was reported in only 26.8% of patients in whom esophagitis was noted at EGD. A histologic diagnosis of active esophagitis was made in less than a third of patients in whom the LA grade was reported; it was only slightly more common than in patients for whom it was not reported (28.2% vs. 25.8%), bit signifi cantly more frequent than in patients whose endoscopic report did not mention esophagitis of Barrett’s (28.2% vs. 18.6%; p<0.001). Th e diagnosis of both erosive esophagitis and Barrett’s mucosa were progressively more common as the LA grade increased. How-ever, the overall endoscopic-histologic correlation remained poor, with less than one-fi ft h of patients with LA grade D having a histologic diagnosis of erosive esophagitis. Eosinophilic esophagitis was similarly distributed amongst all the groups, with the exception of patients with LA grade D. Tar-geted prospective studies are needed to determine whether histopathologic and endoscopic interobserver variability, inadequate biopsy sampling, or inherent limitations of the grading system are at the root of the lack of cor-relation.Disclosure: Drs Alden Kielhorn and Robert Genta are employees of Caris Diag-nostics, Irving, Texas.

20

Randomized Open-Label Trial to Assess the Impact of Dosage Timing of Omeprazole/Sodium Bicarbonate (Zegerid 40 mg) on Healing of Severe Refl ux Esophagitis: Preliminary ResultsDawn Francis, MD,1 Tushar Dabade, MD,1 Adil Abdalla, MD,1 Rayna Grothe, MD,1 Vikneswaran Namasivayam, MD,1 Michael Crowell, PhD, FACG,2 Kee Wook Jung, MD,1 Debra Geno, CCRP,1 Mary Fredericksen, CCRP,1 Felicity Enders, PhD,1 Nancy Diehl, BA,3 Amindra Arora, MBBChir, FACG,1 Joseph Murray, MD, FACG,1 Jeff rey Alexander, MD, FACG,1 Steven Adamson, MD,1 Ramona DeJesus, MD,1 Andrew Majka, MD,1 John Patt, MD,1 Matthew Lohse, MD,1 Judith McElhiney, MD,1 Virender Sharma, MD, FACG,2 Kaiser Lim, MD,1 Ganapathy Prasad, MD,1 Angela O’neil, MD,1 Yvonne Romero, MD1. 1. Mayo Clinic, Rochester, MN; 2. Mayo Clinic, Scottsdale, AZ; 3. Mayo Clinic, Jacksonville, FL.

Purpose: Nighttime gastroesophageal refl ux is important in the develop-ment of refl ux esophagitis. For optimal effi cacy, patients requiring proton pump inhibitor (PPI) therapy are advised to take their medication on an empty stomach 20 to 60 minutes before a meal which can be cumbersome. We hypothesized that immediate-release omeprazole/sodium bicarbonate (IR-OME), taken at bedtime, off ers an alternative option for treatment of esophagitis. To test our hypothesis, we aimed to compare the percentage of subjects with severe esophagitis who achieve complete endoscopic resolution aft er 8 weeks of treatment with diff erent dosage times: morning vs. bedtime.Methods: Th is is a prospective randomized open-label cohort study of out-patients with esophagitis. Subjects were educated about refl ux disease and the proper technique and timing of the medication. Esophagogastroduodenos-copy (EGD) was performed at baseline and aft er 8 weeks of study medication. A 24-hour pH study was off ered at the time of the follow-up EGD, regardless of endoscopic fi ndings. Th e goal is to treat 100 subjects (morning N=50, bed-time N=50).

Results: To date, 58 subjects have been recruited of which 46 have com-pleted the study [31 (67%) male, mean age 58 (SD 12.5, range 22 to 81), LA grades C=28, D=18]. Twenty-two subjects were allocated to the morn-ing dose and 29 to the bedtime dose (with 1 and 4 dropping out of each arm, respectively). Of 21 subjects (C=10, D=11) randomized to morning IR-OME, 15 (71%) had healed at 8 weeks. Th e 6 with persistent esophagitis all demonstrated improvement in severity by one or two grades. Of 25 subjects (C=18, D=7) randomized to bedtime IR-OME, 19 (76%) healed (p=0.74). Four of 6 improved, one had the same grade, and one worsened in severity. Ten of 46 (22%) subjects accepted the off er to undergo pH testing while on study medication. Four discontinued the study medication prior to place-ment of the pH probe and were excluded from this subgroup analysis. Of the 6 subjects who underwent pH testing while on IR-OME, 5 were on the morning dose; 4 (80%) with normalization of pH parameters. One subject on morning IR-OME demonstrated acid refl ux (5.5% overall, 1.9% upright, 9.9% supine). Only one subject on IR-OME at bedtime consented to pH test-ing; their time with acid in the esophagus was normal (0.8% overall, 1.6% upright, 0% supine).Conclusion: Th ese preliminary results suggest that both morning and bedtime dosing of IR-OME are eff ective in resolving severe LA grades C and D erosive refl ux esophagitis at 8 weeks. Too few pH observations have been collected to comment on diff erences in nocturnal supine refl ux between morning and bedtime dosing schedules.Disclosure: Dr Alexander Consulting Meritigae Pharmacia and Wyeth; Research Funding - Merck, Novartis, and Glaxo Smith Kline. Dr Romero - Grant/Research Support and Consultant, Santarus, makers of omeprazole/sodium bicarbonate (Zegerid). No disclosures for: Drs Dawn Francis, Tushar Dabade, Adil Abdalla, Rayna Grothe, Vikneswaran Namasivayam, Kee Wook (Kevin) Jung, Michael Crowell, Felicity Enders, Amindra Arora, Joseph Murray, Steven Adamson, Ramona DeJesus, Andrew Majka, John Patt, Matthew Lohse, Judith McElhiney, Virender Sharma, Kaiser Lim, Ganapathy Prasad, or Angela O’Neil, or Mrs Debra Geno, Mary Fredericksen, or Nancy Diehl.Santarus provided study medication and fi nancial support to conduct the study.

21

Characteristics of Post-Fundoplication SyndromeNasser Hajar, MD, Elizabeth Budman, MS, Richard Rackett, LNP, Amine Hila, MD. United Health Services, Johnson City, NY.

Purpose: To assess dysphagia in patients who underwent Nissen Fundoplica-tion as an element of post fundoplication syndrome.Methods: Retrospective study used information from 13 patients who under-went esophagogastroduodenoscopies and esophageal manometries done pre and post-surgery.Results: Pre-operative results showed 10 patients with normal esophageal manom-etry (EM), 1 with ineff ective esophageal motility (IEM) and 2 patients did not have pre-operative EM. Of the 10 patients who had normal pre-operative EM, 8 remained normal post-operatively, 2 changed from normal to IEM. Th e patient with IEM before surgery had a normal EM aft er surgery. All patients had hiatal her-nias prior to surgery, 7 of the 13 patients (54%) had recurrent hiatal hernias, and 10 of the 13 (77%) had endoscopic evidence of slippage or failure of the surgical wrap.

[19]

LA Grade Total patients ( % ) Median age % Men Active

esophagitis ( % ) Erosive

esophagitis ( % ) Eosinophilic esopha-

gitis ( % ) Barrett’s

mucosa ( % )

A 2,306 (4.7) 54 42.8 623 (27.0) 59 (2.5) 38 (1.6) 99 (4.2)

B 884 (1.8) 62 59.4 262 (29.6) 72 (8.1) 15 (1.7) 53 (6.6)

C 324 (0.7) 60 56.8 104 (32.1) 36 (11.1) 8 (2.5) 36 (11.1)

D 106 (0.2) 64 63.2 31 (29.2) 18 (17.0) 0 19 (17.9)

Esophagitis, NOS 9,876 (19.9) 61 46.3 2,545 (25.8) 465 (4.7) 142 (1.4) 665 (6.7)

Nothing stated 14,401 (29.1) 63 42.0 2,678 (18.6) 317 (2.2) 211 (1.5) 543 (3.8)

© 2009 by the American College of Gastroenterology The American Journal of GASTROENTEROLOGY

Abstracts S9

Conclusion: Failure of the surgical wrap, oft en with recurrence of hiatal her-nia, is the most frequent cause of post-fundoplication dysphagia. A less fre-quent complication is esophageal dysmotility.

22

Routine Screening for Eosinophilic Esophagitis in Patients Presenting with DysphagiaJonathan Ricker, DO,1 Scott McNear, MD,2 Eric Plott, MD,1 Timothy Cassidy, DO,1 Hays Arnold, MD,2 Kevin Franklin, MD1. 1. Gastroenterology, Wilford Hall Medical Center, San Antonio, TX; 2. Brooke Army Medical Center, San Antonio, TX.

Purpose: To identify the prevalence of pathologic eosinophilic esophagitis (EoE) in a cohort of adult patients who present for specialty care in the gastro-enterology clinic with the complaint of esophageal dysphagia.Methods: A prospective, unblinded multicenter study with a total of 111 patients (60 males and 51 females) with a chief complaint of dysphagia and age >18 were enrolled. Exclusion criteria included patients <18 years of age, pregnancy, patients who demonstrated a clear obstructive etiology, or patients utilizing inhaled or systemic corticosteroids. If no obstructive etiol-ogy could be found at the time of endoscopy, patients underwent system-atic biopsy of the duodenum, stomach and esophagus. A total of 20 biopsies (4 from the duodenum, 4 from the stomach, 4 from the distal esophagus, 4 from the mid esophagus and 4 from the proximal esophagus) were taken. Th e biopsies of the stomach and duodenum were utilized to exclude the diag-nosis of eosinophilic gastroenteritis, which is a completely separate entity than EoE. A single pathologist was utilized in processing of the tissue sam-ples, with an eosinophil count of >15 per high power fi eld being considered positive for EoE.Results: Of 111 patients, 80 patients (72%) were found to have non-obstructive dysphagia, 20 patients (18%) were found to have obstructive dysphagia, and 11 patients (10%) withdrew their consent or did not show for their procedure. Patients who withdrew consent or did not show for their procedure were counted as having obstructive dysphagia and were excluded from primary analysis. Of those patients with non-obstructive dysphagia, 17 patients (21.25% 95%CI: 12.21%-30.21%) were found to have histologic characteristics of EoE. In the same group, 31% of males vs. 10.5% of females had histologic characteristics of EoE (p-value 0.024). 25% of Caucasians with non-obstructive dysphagia vs. 6.2% of non-Cau-casians had histologic evidence of EoE (p-value 0.091). The mean age of patients with non-obstructive dysphagia presenting with histologic evi-dence of EoE was 34.3.Conclusion: Patients with non-obstructive dysphagia have a greater than 1 in 5 chance of having histologic evidence of EoE on esophageal biopsy. Th erefore, all adult patients undergoing upper endoscopy for the complaint of dysphagia should have esophageal biopsies obtained if no mechanical cause for their dysphagia is readily apparent.

23

Silent GERD: Is It Diff erent Physiologically than GERD?Bradley Shepherd, MD,1 James Slaughter, DrPH,3 Sam Aznaurov, MD,2 David Barry, MD,2 Michael Vaezi, MD, PhD, MS (Epi), FACG1. 1. Vanderbilt University Medical Center, Division of Gastroenterology, Hepatology, and Nutrition, Center for Swallowing and Esophageal Disorders, Nashville, TN; 2. Vanderbilt University Medical Center, Department of Medicine, Nashville, TN; 3. Vanderbilt University Medical Center, Department of Biostatistics, Nashville, TN.

Purpose: In patients with extraesophageal symptoms without concomitant heartburn (HB) or regurgitation (regurg), there is controversy regarding the role of refl ux disease. In this “silent GERD” category of patients, recent AGA guidelines (Gastroenterology 2008; 135:1392-1413) recommend against acid suppression. Th e presumption being that in those with extraesophageal symptoms acid refl ux is less likely in the absence of typical GERD symptoms. However, there are limited data to support this premise. Th e aim of this physi-ologic study was to investigate if the esophageal acid exposures at baseline are

diff erent among patients with presenting complaints of HB/regurg (esopha-geal syndrome) compared to patients with extraesophageal symptoms (with or without concomitant HB/regurg).Methods: Patients with presenting complaints of HB/regurg and those with extraesophageal symptoms with or w/o concomitant HB/regurg underwent EGD and 48-hr wireless pH monitoring off PPI. Presence of esophagitis, size of hiatal hernia and degree of esophageal acid exposure (total, upright and supine) for both day 1 and day 2 were assessed. Physiologic fi ndings and demo-graphic data (age, gender, BMI) were compared. Regression models were used to assess for predictors of abnormal esophageal acid exposure.Results: 233 pts (mean age 51 yrs; 86% Caucasian; 75% female) were stud-ied. 116 pts had HB/regurg as their chief complaint (Group A) and 117 pts had extraesophageal sx’s (cough—38%, chest pain—30%, hoarseness—22%, asthma-5%, post-nasal drip 5%) of which 43 (37%) had concomitant HB/regurg as chief complaint (Group B) and 74 (63%) did not (Group C). Th e median BMI, prevalence of esophagitis, hiatal hernia, % subjects with abnor-mal esophageal refl ux as well as % time pH<4 were similar between the three groups (Table). More than half (68%) of patients with extraesophageal sx’s w/o HB/regurg. (Group C) had abnormal pH monitoring, similar to the pts with typical esophageal symptoms (Group A) (65%) and pts with extraesophageal symptom with HB/ regurg (Group B) (53%). Th e median (25%-75%) % time pH<4 was similar (p=0.35) in all three groups; Group A=7.5% (4.3%-10.4%); Group B=5.6% (2.0%-10.2%); Group C=6.8% (4.7%-11.4%) (Table) and did not diff er for day 1 or day 2 of the pH monitoring. Regression model identifi ed presence of hiatal hernia as the only signifi cant contributor to esophageal acid exposure (p=0.037).Conclusion: Our data casts doubt into the widely held notion that patients with extra-esophageal symptoms without HB/regurg are less likely to have reflux. We found that this group of patients are equally likely to have physi-ologic esophageal acid exposure, esophageal mucosal damage and struc-tural defects such as hiatal hernia. Thus, GERD may be “silent” but not absent.

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Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablet Compared to Famotidine/Antacid EZ Chew TabletAmy Replogle, MS,1 Peggy M.T. Hwang, PhD,1 Robert Blum, PharmD,2 Jeff rey Levine, MD1. 1. Merck & Co., Inc., Blue Bell, PA; 2. Buff alo Clinical Research Center, LLC, Buff alo, NY.

Purpose: Famotidine/antacid combination tablets (FACT) combine 10 mg of a potent H2 receptor antagonist with standard Ca and Mg containing antacids. Th is combination has been shown to have the benefi t of more rapid relief of symptoms than famotidine alone, and a longer duration of relief than antacid alone. While extremely eff ective for relieving heartburn, the chewable tablet of the original formulation has been described as gritty with an unappeal-ing mouth feel. To provide an alternative formulation for consumers, a soft er, smoother, and non-gritty tablet or an “EZ Chew” formulation of FACT has been developed. In a separate taste test, strong preference is shown for the new EZ Chew tablets over the original formulation of FACT.Methods: Twenty-four healthy subjects underwent a prestudy visit and 3 treatment sessions with each session separated by ~1 week. Subjects were

Group A ( N =117)

Group B ( N =43)

Group C ( N =74) p -value

Age; mean (range) 51 (43 – 59) 52 (42 – 60) 50 (39 – 57) 0.82

BMI; median (25 % – 75 % )

27 (24 – 33) 26 (24 – 30) 28 (25 – 31) 0.80

% Esophagitis 15 12 10 0.54

% Hiatal Hernia 30 23 25 0.55

% Abnormal pH 65 53 68 0.26

Total time pH < 4 median (25 % – 75 % )

7.5 (4.3 – 10.4) 5.6 (2.0 – 10.2) 6.8 (4.7 – 11.4) 0.35

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randomly assigned to 1 of 6 treatment sequences and received each of the 3 treat-ments in a randomized order. Th e 3 treatments included FACT with water, EZ Chew with water, and EZ Chew without water. Following an overnight fast, subjects received the designated treatment and blood was collected over 24 hours postdose for measurement of famotidine concentrations at specifi ed times following each treatment.Results: Th e study demonstrated that a single dose of EZ Chew without water is bioequivalent to a single dose of FACT, as the 90% confi dence interval for the geometric mean ratios (EZ/FACT) for AUC0-∞ and Cmax both fall within the prespecifi ed bounds of (0.80, 1.25). Th e AUC0-∞ and Cmax geometric mean ratios for FACT and EZ Chew without water were 1.05 and 1.03, respectively, and the 90% confi dence intervals were (0.98, 1.13) and (0.93, 1.13). Th e median Tmax was 1.25 and 1.75 hours, and the median apparent half-life was 4.60 and 4.56 hours, respectively. Th e study also demonstrated similar bioequivalence for EZ Chew with water.Conclusion: EZ Chew tablet taken both with and without water and FACT are bioequivalent for famotidine with respect to AUC0-∞ and Cmax. (Th e study did not assess the bioequivalence of antacid component.) Th e improved mouth feel and consumer taste preference should make the new EZ Chew product more palatable to consumers.Disclosure: Amy Replogle - Employee: Merck & Co., Inc. Peggy Hwang - Employee: Merck & Co., Inc. Robert Blum - Investigator - Buff alo Clinical Research Center. Jeff Levine - Employee: Merck & Co., Inc.

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Barrett’s Esophagus Eradication by Radiofrequency and Cryospray AblationAvegail Flores, MD, Sofi ya Reicher, MD, David Chung, MD, Binh Pham, MD, Viktor Eysselein, MD. Medicine, Harbor-UCLA Medical Center, Torrance, CA.

Purpose: Radiofrequency ablation (RFA) with HALO devices (BARRX Medi-cal, Inc) and cryospray ablation (CSA Medical) with low pressure liquid nitro-gen are emerging as eff ective and safe techniques for Barrett’s esophagus (BE) eradication. However, in our experience, RFA can be technically challenging in the distal esophagus, especially in the presence of moderate to large hiatal hernia. Here, we report an interim analysis of a study aimed to evaluate the effi cacy and safety of RFA with the addition of cryospray ablation for nondys-plastic and dysplastic BE.Methods: From 2005-2009, 53 patients with histologically confi rmed BE (dysplastic and nondysplastic; short and long segment) were included in the study. All of them initially received RFA with follow-up endoscopy performed at 3 months. Patients with endoscopically visible BE on follow-up under-went repeated RFA. Plate-based HALO-90 ablation device was used for small (<1 cm) BE islands; otherwise, balloon-based HALO-360 was used. If there was no endoscopically visible BE, 4-quadrant biopsies every 1 cm were per-formed. Cryospray ablation was performed if BE persisted aft er at least 2 RFA sessions. Cryospray ablation was done at 10-sec freeze/thaw cycles (4 cycles per each BE lesion).Results: 53 patients received at least one RFA session. 41 patients had no dysplasia, 3 patients were indeterminate, 7 low grade and 2 high grade. 8 patients were lost to follow-up. Mean BE length was 4.2 cm (1-14 cm). To date, 16 patients (1 high grade, 4 low grade, and 11 nondysplastic) achieved complete BE eradication endoscopically and histologically with all negative biopsies. Th e average number of RFA sessions in this group was 1.9. All 12 patients with dysplasia who received RFA had no evidence of dysplasia histo-logically on follow up biopsies. One patient with low grade dysplasia had small residual islands of BE in the distal esophagus aft er 4 RFA sessions, which were successfully eradicated aft er one cryoablation. 13 patients received cryoabla-tion aft er average of 2.4 RFA sessions. 5 out of 13 patients achieved BE eradi-cation endoscopically and histologically. 6 are awaiting follow up EGD and 2 patients had small <1cm residual BE islands. To date, we have found no major complications when using dual ablative therapies.Conclusion: RFA and cryospray ablation are both promising new techniques for BE eradication. Our rates of BE eradication aft er RFA are similar to previ-ous reports. Our study highlights the use of cryospray ablation as an adjunct tool to RFA, in particular in the distal esophagus where contact with RFA devices can be hampered.

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Reliability of Histopathology in Diagnosing Eosinophilic Esophagitis in AdultsNancy Han, MD, Michael Crowell, PhD, Shabana Pasha, MD, Giovanni DePetris, MD, Virender Sharma, MD, David Fleischer, MD, H. Jae Kim, MD. Gastroenterology, Mayo Clinic Arizona, Scottsdale, AZ.

Purpose: Eosinophilic esophagitis (EE) is an increasingly recognized cause of dysphagia in adults. Th ere are no diagnostic serum markers, and the diagno-sis is based upon the presence of characteristic clinical features and histology. Multiple biopsies of the esophagus are necessary to improve diagnostic sen-sitivity and reliably diagnose EE (Gonsalves et al., GIE 2006). To assess the diagnostic accuracy and reliability of proximal and mid-esophageal biopsies in EE patients.Methods: Data from 16 patients with EE was evaluated. All 16 patients com-pleted an EGD with proximal and mid-esophageal biopsies.Results: A total of 130 biopsy specimens from 16 patients were available for analysis. Th irteen of the 16 patients were male. All patients had solid dyspha-gia and 5 had a history of food bolus while on proton pump inhibitor therapy. Applying the criteria of ≥15 eos/hpf for diagnosis, 54% (70 of 130) of the total biopsies, 47% (27 of 57) of the proximal biopsies and 59% (43 of 73) of the mid biopsies were found to be positive and diagnostic for EE. Of the 16 patients, 2 had positive biopsies in the proximal esophagus only, 4 in the mid esophagus only, and 10 in both locations. Further analysis revealed neither the location nor number of biopsies to be a good predictor of EE (P=NS).Conclusion: Novel histopathologic and endoscopic imaging tools may allow for fewer biopsies to accurately and reliably diagnose EE.

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Should Patients with Severe Refl ux Esophagitis Undergo Repeat Endoscopy Aft er 8 to 12 Weeks of Proton Pump Inhibitor (PPI) Th erapy to Exclude Underlying Barrett’s Esophagus (BE)? Preliminary Results from Two Pro-spective TrialsKee Wook Jung, MD,1 Dawn Francis, MD,1 Amindra Arora, MBBChir,1 Rayna Grothe, MD,1 Felicity Enders, PhD,1 Tushar Dabade, MD,1 Debra Geno, CCRP,1 Joseph Murray, MD,1 Jeff rey Alexander, MD,1 Gianrico Farrugia, MD, FACG,1 Sunanda Kane, MD, FACG,1 Mary Fredericksen, CCRP,1 Navtej Buttar, MD, FACG,1 Michael Crowell, PhD, FACG,2 Giles Locke, MD, FACG,1 Nancy Diehl, BA,1 Louis Wong Kee Song, MD, FACG,1 Kenneth Wang, MD, FACG,1 Ganapathy Prasad, MD,1 Sami Achem, MD, FACG,3 Vikneswaran Namasivayam, MD,1 Virender Sharma, MD, FACG,1 Colin Howden, MD, FACG,4 Yvonne Romero, MD1. 1. Mayo Clinic, Rochester, MN; 2. Mayo Clinic, Scottsdale, AZ; 3. Mayo Clinic, Jacksonville, FL; 4. Northwestern University, Chicago, IL.

Purpose: Retrospective reports have suggested that 5-25% of patients with refl ux esophagitis (RE) at baseline, who undergo repeat esophagogastroduo-denoscopy (EGD) following PPI therapy, have concomitant BE—most short in segment length. Given the retrospective nature of these reports, it is not clear how many patients had intestinal metaplasia of the cardia misdiagnosed as BE. We are recruiting subjects with RE into 2 prospective studies, each with diff erent primary aims. A uniting secondary aim is to assess the prevalence of suspected and unsuspected BE in patients with RE treated with PPI therapy for 8-12 weeks.Methods: Subjects from two studies were pooled for this analysis. Study A’s primary aim is to assess the role of compliance in GERD symptom resolution in subjects with Los Angeles (LA) grades B, C and D RE. Follow-up EGD was left to the discretion of the primary physician. Study B’s primary aim is to com-pare the percent of subjects with LA grades C and D RE who achieve resolution aft er 8 weeks PPI treatment (morning vs. bedtime dosing). Follow-up EGD was mandatory. Endoscopists were not informed of the subject’s participation in a research study. Subjects previously diagnosed with BE were excluded from this analysis.Results: Study A recruited 50 subjects [25 (50%) male, mean age 56 (SD 15), B=40, C=5, D=5], of whom 10 [4 (40%) male, mean age 58 (SD 15), B=7, C=1, D=2] had a follow-up EGD. To date, Study B has recruited 57 subjects of which 45 [31 (69%) male, mean age 56.8 (SD 13), C=27, D=18] have undergone a fol-low-up EGD. Th us, 55 subjects (B=7, C=28, D=20, BMI 31.5) have undergone baseline and follow-up EGD aft er 8-12 weeks PPI therapy and are the subjects

© 2009 by the American College of Gastroenterology The American Journal of GASTROENTEROLOGY

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of this analysis. Five (C=3, D=2) of 55 (9%) subjects were newly diagnosed with biopsy-proven BE at follow-up EGD [overall 2 (40%) male; mean age 55 (SD 11); BMI 35.3, short (< 3 cm) N=4 (2 male, lengths ranging from islands to 2 cm); long (>3 cm) N=1 (0 male, 5 cm). In 5 (100%) cases, BE was unex-pected. Th e BMI of the 50 RE subjects who did not have BE at follow up EGD was 31.3 (p=0.16).Conclusion: In this prospective study, 10% of subjects with LA grade C or D RE had concomitant BE that could not be recognized during the initial endo-scopy in the setting of diff use infl ammation. Unsuspected BE was not found in subjects with LA grade B RE. Subjects with RE and BE tended to be more obese than subjects with RE alone, although this fi nding did not achieve statistical signifi cance. Th ese prospective results suggest that patients with severe LA grade C or D disease undergo repeat EGD aft er 8 to 12 weeks of PPI therapy to exclude underlying BE.Disclosure: Dr Alexander - Consulting Meritigae Pharmacia and Wyeth; Research Funding - Merck, Novartis, and Glaxo Smith Kline. Dr Howden - Consultant - Santarus and Takeda, Speakers Bureau - Santarus and Takeda. Dr Romero - Grant/Research Support and Consultant, Santarus, makers of omeprazole/sodium bicarbonate (Zegerid), and Grant/Research Support and Consultant, AstraZeneca, makers of esomeprazole (Nexium). No disclosures for: Drs Jung, Francis, Arora, Grothe, Enders, Dabade, Murray, Farrugia, Kane, Buttar, Crow-ell, Locke, Wong Kee Song, Wang, Prasad, Sharma, Namasivayam, and Achem, and Mrs Geno, Fredericksen, and Diehl.Th is research was supported by an industry grant from AstraZeneca funded Study A in this abstract. Th ey supplied esomeprazole. Santarus funded Study B in this abstract. Th ey supplied omeprazole/sodium bicarbonate. Note, they are both referred to as PPI therapy. Th e names of their products are not described in the abstract.

28

High Prevalence of Barrett’s Esophagus in Latinos Undergoing EndoscopyKian Keyashian, MD, Van Hua, MD, Kiran Narsinh, MD, Michael Kline, MD, AnnMaria DeMars, PhD, John Kim, MD. University of Southern California, Los Angeles, CA.

Purpose: Th e highest incidence of Barrett’s Esophagus (BE) has been observed in middle-aged white males with chronic gastroesophageal refl ux disease (GERD). Latinos constitute the largest and fastest-growing minority ethnic group in the United States. Previous studies comparing the prevalence of BE in Latinos compared to non-Latino Whites have been inconsistent. Th e aim of this study was to compare the prevalence of BE in Latinos and non-Latino Whites and to determine risk factors associated with BE in Latinos.Methods: Between 3/2005 and 1/2009, consecutive Latino and non-Latino White patients who underwent endoscopy for primary symptoms of GERD were identifi ed by reviewing the internal endoscopy database at Los Angeles County+University of Southern California Medical Center. BE was defi ned by columnar-lined distal esophagus on endoscopy confi rmed by intestinal metaplasia. Clinical features and endoscopic fi ndings were retrospectively reviewed.Results: Of 672 patients who underwent endoscopy, the mean age was 50.4±11.5, 31% were male, and 92.1% were self-identifi ed as Latinos. Sev-enty (10.4%) patients had endoscopic and histologic evidence of BE. Among Latinos and non-Latino Whites, there was no diff erence in prevalence of BE (10.3% vs. 11.3%, p=0.82) or long segment BE (24.4% vs. 25%, p=0.98) and no diff erence in average length of BE (2.4±2.7 cm vs. 2.0±2.0 cm, p=0.75). Th is lack of statistical diff erence in prevalence of BE also held true when Latinos and non-Latino Whites were compared by gender (males: 14.5% vs. 13.8%, p=.96; females: 8.6% vs. 8.3%, p=0.92). Th e only case of BE with dysplasia (high-grade) was in the Latino group. No cases of adenocarcinoma were iden-tifi ed. In univariate analysis, factors associated with increased risk of BE were age greater than 50 (p=0.013), male gender (p=0.023), and diabetes (p=0.021). However, in multivariate analysis, only age greater than 50 showed a statisti-cally signifi cant association with BE (see Table).Conclusion: In the largest cohort of patients evaluating endoscopic and his-tologic BE in Latinos, the prevalence of BE in Latinos was comparable to non-Latino Whites. In addition to established risk factors, insulin resistance was

also associated with BE in this predominantly Latino population. Our study suggests that Latino race may confer higher risk for the development of BE than previously described in literature and should be considered in individual-ized screening practices.

29

Dexlansoprazole MR for Treatment for Nocturnal Heartburn in Patients with Symptomatic Nonerosive GERDRonnie Fass, MD, FACG,1 David Johnson, MD, FACG,2 William Orr, PhD,3 M. Claudia Perez, MD,4 Cong Han, PhD,4 Reema Mody, PhD,5 Kathleen Stern, PhD4. 1. University of Arizona Health Sciences Center, Tucson, AZ; 2. Eastern Virginia Medical School, Norfolk, VA; 3. Lynn Health Science Institute and Oklahoma University Health Sciences Center, Oklahoma City, OK; 4. Takeda Global Research & Development Center, Inc., Deerfi eld, IL; 5. Takeda Pharmaceuticals North America, Inc., Deerfi eld, IL.

Purpose: Nocturnal heartburn (HB) and sleep disturbances commonly occur in patients with GERD. Th ese symptoms are important to treat since nighttime refl ux creates a high risk for esophagitis and impacts quality of life. Th is study evaluated the eff ects of dexlansoprazole MR (DEX), a PPI with a Dual Delayed Release™ formulation designed to extend the duration of acid suppression, in patients with nighttime symptoms.Methods: A multicenter, randomized, double-blind, placebo controlled, parallel group trial in patients aged 18-66 with symptomatic GERD, with no esophageal erosions based on endoscopy. Th e patients enrolled in the study had moderate to very severe nocturnal HB and GERD-related sleep distur-bances on at least 3 of 7 nights based on twice daily diary entries, recorded upon waking and before bedtime. Night time was defi ned as the time at which the patient laid down to fall asleep to the time when the patient woke up and began daily activities. Patients received DEX 30 mg or placebo (PBO) orally, every morning for 4 weeks. In addition to the diary, patients completed ques-tionnaires on sleep quality and work productivity at baseline and week 4. Th e primary endpoint was the % of nights without heartburn over 4 weeks. Sec-ondary endpoints were % of patients with relief of nocturnal HB and % of patients with relief of GERD-associated sleep disturbances over the last 7 days of treatment. Relief was rigorously defi ned as 6 of 7 days without nighttime HB and at most 1 night with mild HB and 6 of 7 days without GERD associated sleep disturbances.Results: 305 patients were randomized. Patients taking DEX had a statisti-cally signifi cantly greater % of nights without HB during 4 weeks of treat-ment vs. PBO (median of 73% vs. 36%, respectively; Wilcoxon rank-sum test p<0.001); the therapeutic gain was greater in patients with more severe baseline symptoms. During the last 7 days of treatment, relief of noctur-nal HB and relief of GERD-related sleep disturbances occurred in a sig-nifi cantly higher % of patients who received DEX vs. PBO (48% vs. 20%, and 70% vs. 48%, respectively; Fisher’s exact test p<0.001 for both). Patients receiving DEX had signifi cantly greater improvement in measurements of sleep quality and work productivity. Th ere were no clinically signifi cant dif-ferences between treatment groups regarding adverse events or other safety parameters.

Multivariate analysis for BE

Variable Odds ratio OR 95 % CI p value

Latino 1.016 0.314 – 3.085 0.979

Male 1.874 0.912 – 3.846 0.088

Age >50 1.044 1.011 – 1.079 0.010

Diabetes 2.255 0.964 – 5.263 0.061

BMI 0.986 0.930 – 1.046 0.643

Tobacco 0.998 0.363 – 2.740 0.997

ASA / NSAID 1.316 0.378 – 1.528 0.441

Hiatal hernia 1.243 0.617 – 2.506 0.543

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Conclusion: In patients with signifi cant complaints of nighttime HB and associated sleep disturbances, DEX 30mg was highly eff ective in improving strictly defi ned symptoms of nighttime HB and sleep quality as well as work productivity. Sponsored by Takeda Global Research & Development Center, Inc., Deerfi eld, IL, USA.Disclosure: Ronnie Fass - Consultant - Takeda, Xenoport, Vecta, Eisai, Salix; Research Suuport - Takeda, Wyeth, AstraZeneca, Sucampo; Speakers Bureau - Eisai, Takeda. David Johnson-Consultant - Takeda, AstraZeneca, Esai, Novartis; Research Support - Takeda, AstraZeneca; Clinical Investigator; Takeda, AstraZeneca, Novartis. William Orr-Speaker, Consultant, Research Support - Takeda. M Claudia Perez, Cong Han, Reema Mody, Kathleen Stern-Employee: Takeda.

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Eff ects of Dexlansoprazole MR on Sleep Quality and Health-Related Quality of Life (HRQOL) in Patients with Symptomatic Nonerosive GERDWilliam Orr, PhD,1 Ronnie Fass, MD, FACG,2 David Johnson, MD, FACG,3 Reema Mody, PhD,4 M. Claudia Perez, MD,5 Kathleen Stern, PhD,5 Cong Han, PhD5. 1. Lynn Health Science Institute and Oklahoma University Health Sciences Center, Oklahoma City, OK; 2. University of Arizona Health Sciences Center, Tucson, AZ; 3. Eastern Virginia Medical School, Norfolk, VA; 4. Takeda Pharmaceuticals North America, Inc., Deerfi eld, IL; 5. Takeda Global Research & Development Center, Inc., Deerfi eld, IL.

Purpose: Nocturnal heartburn (HB) and sleep disturbances commonly occur in patients (pts) with GERD and impact daytime performance and health-related quality of life (HRQOL). Th is study evaluated the eff ects of dexlan-soprazole MR (DEX), a PPI with a Dual Delayed Release™ formulation, on sleep quality and HRQOL in GERD pts with nighttime symptoms and GERD-related sleep disturbances.Methods: A multicenter, randomized, double-blind, placebo controlled, parallel group trial in patients aged 18-66 with symptomatic GERD, a his-tory of nocturnal HB and GERD associated sleep disturbances, with no esophageal erosions based on endoscopy. Patients enrolled had moderate to very severe nocturnal HB and GERD-related sleep disturbances for at least 3 of 7 nights based on twice daily diary entries, and were random-ized within 4 days after this 7 night diary qualification. Patients received DEX 30mg or placebo (PBO) orally, every morning for 4 weeks. Patients completed the Pittsburgh Sleep Quality Index (PSQI) and the Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact (NGERD) Questionnaire at baseline and at the end of week 4. The PSQI is a vali-dated, reliable instrument to measure sleep quality over the last month. Items yield a global score ranging from 0-21. Higher scores represent worse sleep quality; scores >5 and <5 distinguish populations of poor and good sleep quality, respectively. The NGERD questionnaire is a validated HRQOL instrument to assess the severity and frequency of nocturnal GERD symptoms, next morning impact and concern about GERD over the past 2 weeks. Th e total score ranges from 0-95; higher scores repre-sent worse HRQOL. Changes from baseline to week 4 were analyzed using analysis of covariance with treatment as the factor and baseline score as a covariate.Results: 305 patients were randomized; mean age 44 yrs, 110 men (36%) and 195 women (64%). Patient demographics, sleep quality, NGERD subscale scores, and severity of HB at baseline were similar between DEX and PBO groups. DEX patients had signifi cantly greater improvements in sleep qual-ity and total and subscale NGERD endpoints at 4 weeks compared to PBO patients (Table).Conclusion: Once daily DEX 30mg is eff ective in improving sleep quality and nighttime symptom severity in patients with nighttime HB and GERD-related sleep disturbances. Sponsored by Takeda Global Research & Development Center, Inc., Deerfi eld, IL, USA.Disclosure: William Orr - Speaker, Consultant, Research Support - Takeda Ron-nie Fass - Consultant: Takeda, Xenoport, Vecta, Eisai, Salix; Research Suuport: Takeda, Wyeth, AstraZeneca, Sucampo; Speakers Bureau - Eisai, Takeda. David Johnson - Consultant - Takeda, AstraZeneca, Esai, Novartis; Research Support:

Takeda, AstraZeneca; Clinical Investigator; Takeda, AstraZeneca, Novartis. M Claudia Perez, Cong Han, Reema Mody, Kathleen Stern - Employee: Takeda.

31

Eff ect of Dexlansoprazole MR on Improving Work Productivity and Daily Activities in Patients with Symptomatic Nonerosive GERDDavid Johnson, MD, FACG,1 Ronnie Fass, MD, FACG,2 William Orr, PhD,3 Reema Mody, PhD,4 M. Claudia Perez, MD,5 Kathleen Stern, PhD,5 Cong Han, PhD5. 1. Eastern Virginia Medical School, Norfolk, VA; 2. University of Arizona Health Sciences Center, Tucson, AZ; 3. Lynn Health Science Institute and Oklahoma University Health Sciences Center, Oklahoma City, OK; 4. Takeda Pharmaceuticals North America, Inc., Deerfi eld, IL; 5. Takeda Global Research & Development Center, Inc., Deerfi eld, IL.

Purpose: Nocturnal heartburn (HB) and sleep disturbances commonly occur in patients with GERD and may have a signifi cantly negative impact on qual-ity of life and work productivity. Th is study evaluated the eff ects of dexlan-soprazole MR (DEX), a PPI with a Dual Delayed Release™ formulation, on work productivity and regular daily activities in GERD patients with nighttime symptoms and GERD-related sleep disturbances.Methods: A multicenter, randomized, double-blind, placebo controlled, parallel group trial in patients aged 18-66 with symptomatic GERD, a history of nocturnal HB and GERD associated sleep disturbances, with no esophageal erosions based on endoscopy. Patients enrolled had moderate to very severe nocturnal HB and GERD-related sleep disturbances for at least 3 of 7 nights based on twice daily diary entries, and were randomized within 4 days aft er this 7 night diary quali-fi cation. Patients received DEX 30mg or placebo (PBO) orally, every morning for 4 weeks. At baseline and at the end of week 4, patients completed the Work Productivity Activity Impairment-Specifi c Health Problem (WPAI-SHP) ques-tionnaire, a validated 6-item questionnaire. Th e WPAI-SHP was used to assess the impact of GERD-related sleep disturbances on impairment of work productivity and regular activities. Subscales were expressed as impairment percentages, with

Outcomes DEX 30 mg mean ± s.d. PBO mean ± s.d. p value

PSQI score n * 137 133 0.001

Baseline 9.30 ± 3.57 8.87 ± 3.64

Week 4 6.60 ± 3.71 7.52 ± 3.70

Change − 2.70 ± 3.08 − 1.35 ± 3.23

NGERD total HRQOL score (Range: 0 – 95)

n*

Baseline

Week 4

Change

139

46.55 ± 17.71

18.17 ± 19.34

− 28.38 ± 20.26

136

48.24 ± 16.95

30.23 ± 22.11

− 18.01 ± 18.78

< 0.001

NGERD symptom subscale score (Range: 0 – 65)

n* 139 136 < 0.001

Baseline 29.20 ± 12.13 30.33 ± 11.29

Week 4 10.85 ± 13.03 18.45 ± 14.67

Change − 18.35 ± 13.51 − 11.88 ± 13.01

NGERD morning impact subscale score (Range: 0 – 10)

n* 138 136 < 0.001

Baseline 5.72 ± 2.70 5.86 ± 2.65

Week 4 2.59 ± 2.81 4.09 ± 3.01

Change − 3.13 ± 3.30 − 1.77 ± 2.62

NGERD concern sub scale score (Range: 0 – 20)

n* 138 136 < 0.001

Baseline 11.72 ± 4.78 12.05 ± 5.09

Week 4 4.75 ± 5.12 7.69 ± 6.10

Change − 6.96 ± 5.52 − 4.36 ± 5.08

*For each subscale, only patients with baseline and Week 4 data available were included in each analysis.

© 2009 by the American College of Gastroenterology The American Journal of GASTROENTEROLOGY

Abstracts S13

higher numbers indicating greater impairment and less productivity. Changes from baseline to week 4 in WPAI-SHP endpoints were analyzed using analysis of covariance with treatment as the factor and the baseline value as a covariate.Results: 305 patients were randomized into the study, mean age 44 yrs, 110 men (36%) and 195 women (64%). Baseline characteristics were similar between the treatment groups. For each subscale, only patients with baseline and Week 4 data available were included in each analysis. 184 patients reported being employed at both baseline and week 4. As measured by change from baseline, DEX patients had a signifi cantly greater decrease in impairment of regular daily activities compared to PBO. Among those employed, DEX patients had a signifi cantly greater decrease in impairment of overall work productivity com-pared to PBO (Table).Conclusion: DEX 30 mg is eff ective in improving overall work productivity and decreasing impairment of regular daily activities in patients with signifi -cant complaints of nighttime HB and associated sleep disturbances. Sponsored by Takeda Global Research & Development Center, Inc., Deerfi eld, IL, USA.Disclosure: David Johnson - Consultant: Takeda, AstraZeneca, Esai, Novartis; Research Support: Takeda, AstraZeneca; Clinical Investigator; Takeda, Astra-Zeneca, Novartis. William Orr-Speaker, Consultant, Research Support: Takeda Ronnie Fass - Consultant: Takeda, Xenoport, Vecta, Eisai, Salix; Research Sup-port: Takeda, Wyeth, AstraZeneca, Sucampo; Speakers Bureau: Eisai, Takeda. M Claudia Perez, Cong Han, Reema Mody, Kathleen Stern - Employee: Takeda.

32

Catheter-free Esophageal pH Monitoring: Are We Getting Useful Clinical Information?Jeff rey Gill, MD, Yasser Saloum, MD, Katheryn Downs, MPH. Division of Digestive Diseases and Nutrition, University of South Florida, Tampa, FL.

Purpose: Despite the widespread use of catheter-free esophageal pH moni-toring (CFEPHM) in clinical practice, questions still remain regarding its appropriate use as a diagnostic tool. Physiologic gastroesophageal refl ux (GER) is noted aft er meals but not during sleep whereas pathologic refl ux occurs in any position. Currently, pH testing is recommended before fundo-plication, aft er fundoplication if symptoms recur, in patients with persistent symptoms despite acid suppression, and when extraesophageal refl ux is sus-pected. Our purpose is to compare the prevalence of supine and upright acid refl ux during CFEPHM, address patients’ compliance with symptoms report-ing, correlate symptoms with acid refl ux, and compare DeMeester scores on days 1 and 2.Methods: We conducted a review of 222 consecutive CFEPHM reports between January 2007 and September 2008.

Results: When considering the position, the prevalence of acid refl ux (93.1% vs. 62.8%, P<.001), time pH<4 (8.23% vs. 6.79%, P=.002), and the number of long refl ux episodes (5.73 vs. 2.42, P<.001) was greater in upright position. Of patients reporting symptoms, only 18.7% had acid refl ux >20% of the time, and 4.2% had it >50% of the time, with an overall average symptom correlation of only 10.6%. Th irteen percent of patients did not indicate any symptoms during testing, 34.2% did not record when they were supine, and 23.4% did not record meal times. DeMeester scores tend to be higher on day 1 than day 2 (P<.023).Conclusion: As with physiologic refl ux, we found for the fi rst time that patho-logic acid refl ux is more common in the upright position making recommenda-tions such as raising the head of bed and avoiding late meals greatly unproven. While most patients report nocturnal symptoms, the correlation of symptoms with acid refl ux is weak at best. As reported previously, we confi rmed this obser-vation by showing that symptom correlation was very poor across the board, with only 10.6 % overall correlation of acid refl ux during symptoms. Finally, with more than 1/4-1/3 of patients not recording meals or position, respectively, ways to improve patient compliance is critical to improve the usefulness of the test. Higher DeMeester scores on day 1 may be due to the eff ect of sedation on lower esophageal sphincter, suggesting that day 2 data may be more accurate than the average score. Our study recognizes many fl aws in the use or the interpretation of CFEPHM, some of which can be improved with better patient education. Others may require changes in the analysis of the test or the test itself. Further prospec-tive studies may be helpful in making this test a more effi cient clinical tool.

33

Secular Trends in the Epidemiology and Natural History of Barrett’s Esophagus in Olmsted County, MN: A Population Based Cohort StudyGanapathy Prasad, MD, MS, Kenneth Wang, MD, Yvonne Romero, MD, Nicholas Talley, MD, PhD, Giles Locke, MD, Cathy Schleck, BS, Alan Zinsmeister, PhD, Ngozi Okoro, MD, Kelly Dunagan, LPN, Lori Lutzke, LPN, Mary Frederickson, CCRP, Debra Geno, CCRP, Lynn Borkenhagen, MS, Yutaka Tomizawa, MD. Mayo Clinic, Rochester, MN.

Purpose: Esophageal adenocarcinoma (EAC) incidence is exponentially ris-ing. BE is the strongest risk factor for EAC. Data on the incidence of BE is confl icting. Data from the U.S. is entirely from referral centers. We aimed to: 1) Estimate prevalence and incidence of clinically diagnosed BE in Olmsted County, MN (from 1976-2006). 2) Describe the natural history of BE in a population based cohort.Methods: Patients with BE (endoscopically visible 1 cm columnar mucosa with intestinal metaplasia) from 1977-2006 were identified using the Rochester Epidemiology Project (REP) resources. Demographic, clinical and endoscopic data was abstracted from medical records and pathology confirmed by GI pathologists. Overall survival and survival

[31]

Subscale DEX 30 mg mean ± s.d. PBO mean ± s.d. p value

Overall work productivity impairment ( % ) n 91 78 0.003

Baseline 38.08 ± 29.03 40.99 ± 27.77

Week 4 13.04 ± 19.94 23.93 ± 26.47

Change − 25.04 ± 29.08 − 17.06 ± 26.49

Impairment while working ( % ) n 93 84 0.001

Baseline 36.99 ± 27.93 40.36 ± 27.26

Week 4 12.26 ± 19.00 23.33 ± 25.43

Change − 24.73 ± 28.38 − 17.02 ± 24.92

Activity impairment ( % ) n 140 136 0.001

Baseline 43.14 ± 26.34 46.32 ± 27.02

Week 4 16.29 ± 22.64 26.47 ± 25.92

Change − 26.86 ± 29.77 − 19.85 ± 28.47

The American Journal of GASTROENTEROLOGY VOLUME 104 | SUPPLEMENT 3 | OCTOBER 2009 www.amjgastro.com

AbstractsS14

free of progression (to HGD/EAC) was assessed using the Kaplan-Meier method.Results: 401 patients were identifi ed. 287 (72%) were male. Mean (s.d.) age was 63 (14) yrs. Mean (s.d.) BE length was 4.8 (3.3) cm. Mean (s.d.) BMI was 30 (6). 268 subjects (67%) are alive. Th e age and sex adjusted (U.S. Whites 2000) inci-dence of BE in Olmsted County over the last 3 decades increased from 1977 to 1996 (p<0.001) but remained stable from 1997-2006 (Figure 1). Th e prevalence (95%CI) of BE as of 1/1/2007 in Olmsted County was 21.8 (19.1, 24.5)/100,000 population (autopsy assessed prevalence was 37/100,000 population in 1987). Baseline pathology was no dysplasia in 277 (69%) patients, LGD in 58 (14%), HGD in 9 (2%) and EAC in 57 (14%). Median follow-up was 5.9 years. A total of 28 patients without baseline HGD or EAC progressed to HGD (9) or EAC (19): cumulative probability of progression to HGD or EAC of 10.4% at 10 years. Survival free of progression is depicted in Figure 2.Conclusion: Th ough the incidence of EAC continues to increase exponentially in the U.S., the incidence of clinically diagnosed BE appears to be stable over the last decade. Factors promoting progression to EAC should be studied. Th e pro-portion of “undiagnosed BE” in Olmsted County appears to be decreasing.

34

Absence of a Large Hiatal Hernia is Predictive of Regression in Barrett’s EsophagusHumberto Sifuentes, MD,1 Joshua Melson, MD,1 Sohrab Mobarhan, MD, FACG,1 Samad Soudagar, MD,1 Salman Mohiuddin, BS,1 Sri Komanduri, MD, MS2. 1. Gastroenterology, Rush University Medical Center, Chicago, IL; 2. Northwestern Memorial Hospital, Chicago, IL.

Purpose: Regression of Barrett’s esophagus (BE) has been described in a subset of short segment BE (SSBE) patients. Th e role of hiatal hernia (HH) size in the

regression of BE is not well defi ned. Gastroesophageal disease and HH play a role in the development of BE. Th e aim of this study is to assess the role of HH in the regression of BE.Methods: BE patients with endoscopies from 2003-2008 who have been followed up for a minimum of 2 years and have had at least one follow-up endoscopy at least 6 months apart were included in the analysis. Complete regression of BE was defi ned as an absence of endoscopic and histologic evidence of BE at repeat endoscopy at least 6 months apart. Th e role of BE segment length, HH, and demographic data were assessed as possible predictors of BE. Two-way chi squared analysis or Fisher’s Exact Test was performed to assess signifi cance. HH was defi ned as a 2 cm diff erence from the diaphragmatic hiatus to top of the gastric folds. Long segment Barrett’s esophagus (LSBE) was defi ned as ≥3 cm in length.Results: In total, 105 patients were followed over time and 19/105 (18.1%) patients had complete regression of BE on repeat endoscopy. SSBE regressed on second biopsy in 19/84 (22.6%) patients. No patient with LSBE 0/21 (0%) had regression. There was no difference in those that regressed and those that did not for age and gender. The presence of any HH in regressors was 11/19 (57.9%) and for nonregressors was 76/86 (88.4%) (p=0.004). The presence of a HH ≥3 cm was 1/19 (5.3%) in regres-sors and for nonregressors was 28/86 (32.6%) (p=0.021). Proton pump inhibitor usage was seen in 98/105 (93.3%) of patients and was not sta-tistically more prevalent in those that regressed versus those that did not. Regressors had a BMI >35 in 2/19 (10.5%) while nonregressors had BMI >35 25/86 (22%) (p=0.077).Conclusion: Complete regression of SSBE was noted in 19/84 (23%) patients. LSBE did not regress on repeat endoscopy in 21 patients. The majority of patients with BE who regressed did not have a ≥3 cm hiatal hernia 18/19 (94.7%). Regressors were less likely to be obese when com-pared with nonregressors. While analysis of a prospective series of patients is needed, it appears that the absence of a large HH is predictive of regres-sion in SSBE.

35

Association Between Goblet Cell Density and Intraluminal pH in Patients with Long Segment Barrett’s EsophagusShahin Ayazi, MD, Dimitrios Th eodorou, MD, Joerg Zehetner, MD, Arzu Oezcelik, MD, Emmanuele Abate, MD, Steven DeMeester, MD, John Lipham, MD, Farzaneh Banki, MD, Jeff rey Hagen, MD, Tom DeMeester, MD, FACG. University of Southern California, Los Angeles, CA.

Purpose: Barrett’s esophagus (BE) develops in the setting of longstand-ing gastroesophageal refl ux disease (GERD). Th e histology of BE has been defi ned, with goblet cells always located proximally with variable distribu-tion distally. Th e aim of this prospective study was to measure the gradient of esophageal pH in normal subjects and patients with long segment BE, and to correlate esophageal pH with goblet cell density in patients with Barrett’s esophagus.Methods: A novel 6 channel pH catheter was positioned with the most dis-tal channel in the stomach with the remaining sensors located 1 cm below and at 1, 3, 5 and 8 cm above the manometrically determined upper bor-der of the lower esophageal sphincter in 5 normal subjects and 6 patients with long segment Barrett’s esophagus [length of BE: median 8 (6-9) cm]. Patients with Barrett’s esophagus also underwent endoscopy and had four quadrant biopsies at levels corresponding to the location of the pH sensors. Goblet cell density was graded by a single experienced pathologist using a scale of 0-3 with 3 being the greatest density and 0 representing absence of goblet cells. The mean score at each level was calculated and scores from different levels were compared using the Kruskal-Wallis test. The median pH over the 24 hour recording period was calculated for each pH sensor location.Results: In normal subjects, the median esophageal pH was > 5 at all levels with no gradient evident. In patients with BE, a pH gradient was present in the esophagus ranging from 2.8 at the gastroesophageal junction (GEJ) to 4.7, at the sensor located 8 cm above the GEJ (Figure). Th e median pH was signifi cantly lower at all pH sensor levels in patients with Barrett’s

Figure 1.

Figure 2.

© 2009 by the American College of Gastroenterology The American Journal of GASTROENTEROLOGY

Abstracts S15

esophagus compared to normal subjects. Th ere was a signifi cant diff erence in goblet cell density along the Barrett’s segment with the highest density at the top, corresponding to the highest median pH in the Barrett’s segment [Goblet cell density grading (median): 3 at proximal, 2 at mid and 1 at distal, p=0.007].Conclusion: In contrast to normal subjects, patients with Barrett’s esophagus have a pH gradient in the esophagus. The density of goblet cells in the columnar segment inversely correlates with esophageal acid exposure suggesting that promoters of goblet cell differentiation are pH sensitive.

36

A Reversible Achalasia-Like Disorder Aft er Laparoscopic Adjustable Gastric BandingAbraham Khan, MD, Christine Ren, MD, Morris Traube, MD, JD. NYU Langone Medical Center, New York, NY.

Purpose: Obesity is an increasingly signifi cant health problem, and laparo-scopic adjustable gastric banding (LAGB) is a popular surgical option to treat morbid obesity. Several studies have reported the development of esopha-geal dilation in patients aft er LAGB, but the eff ect of banding on esophageal peristalsis and the potential reversibility of aperistalsis has received only little attention, mainly in the surgical literature. Our aim was to report our expe-rience with six patients who developed manometric evidence of esophageal aperistalsis following LAGB.Methods: We retrospectively reviewed the clinical records and manometric data of six patients referred between September 2005 and July 2008 to our Center for Esophageal Disease for evaluation of dysphagia or heartburn that developed aft er LAGB, and in whom manometric studies showed complete aperistalsis. Clinical follow-up was obtained through April 2009. Each patient had been followed by the surgical team who placed the band, with postopera-tive fl uid adjustments, and potential band removal, depending on the degree of weight loss and symptoms. We had recommended that all of these patients with aperistalsis have the fl uid in the port completely removed to assess revers-ibility of esophageal aperistalsis.Results: Six patients (all female, range 43-61 years old) evaluated because of dysphagia or heartburn aft er LAGB had complete aperistalsis on manom-etry. Five of the six patients had at least one repeat manometry (Table 1) aft er removal of all the fl uid from the port (N=4) or aft er surgical removal of the band (N=1). Th e repeat manometric studies were done from days to months aft er the initial manometry. All patients reported clinical improve-ment at the time of the repeat manometry. Aft er fl uid or band removal, two patients (Patient 1 and Patient 2) had partial return of peristalsis, one (Patient 4) had normal peristalsis, and two others (Patient 3 and Patient 5) had con-tinued aperistalsis. Another patient (Patient 6) initially declined fl uid removal and repeat manometry. Aft er esophageal dilation on imaging and progressive pulmonary deterioration, the fl uid was entirely removed. Th e patient did not report for repeat manometry, but imaging showed improvement in her esoph-ageal dilation aft er fl uid removal.

Conclusion: In our six patients, an obstructive eff ect aft er LAGB caused an achalasia-like esophageal aperistalsis. Th e eff ect was generally at least partly reversible but may possibly be irreversible. Gastroenterologists caring for patients who have had LAGB need be aware of this achalasia-like abnormality aft er LAGB, as the treatment of such patients diff ers from those with primary achalasia.

37

Th e Reproducibility of Impedance-pH Test Tesults for Diagnosing GERD in Symptomatic PatientsAnand Raman Kumar, MD, MPH, Stacey Zavala, MD, Sherry Pomerantz, PhD, Philip Katz, MD, FACG. Medicine/Gastroenterology, Albert Einstein Medical Center, Philadelphia, PA.

Purpose: Th ough impedance-pH test potentially increases the diagnostic accuracy for gastro-esophageal refl ux disease (GERD) by detecting the non-acid refl ux in addition to the acid refl ux, no reproducibility data currently exist for symptomatic adults in the United States. Th e primary aim of this study was to assess the reproducibility of the diagnostic result of impedance-pH test in symptomatic adults. In addition, the reproducibility of the correlation of refl ux episodes with symptoms (Symptom Index—SI) was studied.Methods: Th is was a retrospective study that included all patients who had two impedance-pH studies in the esophageal laboratory at our institution since 2003. For those patients who had more than two tests, only the fi rst two were included in the analysis. Total number of refl ux episodes was categorized as normal if it was less than 73. Th e agreement in this categorization at each of the impedance-pH study was then analyzed using a Kappa coeffi cient. Simi-larly, agreement between the symptom indices for each symptom was analyzed using Kendall’s W coeffi cient (coeffi cient of concordance) and Bland-Altman plots.Results: A total of 16 subjects, with 10 women and 6 men, were found to have had two impedance-pH tests. Th e mean age of the patients was 52 years. Th e Kappa coeffi cient for the refl ux episodes categorized as normal or abnormal was 0.45, suggesting only a moderate degree of agreement between the diag-nostic results of the two impedance-pH tests. A very poor level of agreement (Kendall’s W=0.01) for the symptom indices was found for the symptoms that persisted at the two studies.Conclusion: Th is study suggests that there might be a need to revise using only the number of refl ux episodes to categorize impedance-pH test as normal or abnormal. Th is questions the reliability of the current diagnostic criteria for analysis of impedance-pH test for GERD. Th e results in this small retrospective study need to be further confi rmed in a well-designed relatively large prospec-tive study assessing the criteria for diagnosing GERD using impedance-pH test in symptomatic adults.

Table 1

Patient

Lap band

placed

Date of initial

mano metry Percent

peristalsis Intervention

Date of repeat

mano metry Percent

peristalsis

1 5 / 02 9 / 20 / 05 0 All fl uid out 9 / 22 / 05 33

2 3 / 02 4 / 27 / 06 0 Band Removed

9 / 26 / 06 58

3 11 / 01 5 / 31 / 06 0 All fl uid out 10 / 17 / 06 0

4 10 / 02 8 / 8 / 06 0 All fl uid out 10 / 10 / 06 80

5 11 / 02 12 / 15 / 06 0 All fl uid out 2 / 23 / 07 0

6 12 / 06 6 / 26 / 07 0 All fl uid out

The American Journal of GASTROENTEROLOGY VOLUME 104 | SUPPLEMENT 3 | OCTOBER 2009 www.amjgastro.com

AbstractsS16

38

Eosinophilic Esophagitis (EoE): Higher Th an Expected Prevalence of Atyp-ical Symptoms, HLA DQ8, Elevated Antigliadin and ASCA Antibodies, and Elevated Mast Cells in DuodenumJackie Makapugay, MD,2 Scot Lewey, DO, FACG1. 1. Medicine, Division of Gastroenterology, Rocky Vista University College of Osteopathic Medicine, Colorado Springs, CO; 2. GI Pathology, Memphis, TN.

Purpose: Retrospectively review clinical characteristics of eosinophilic esoph-agitis (EoE) from observational data with attention to demographics, symp-toms, histology and any associated serologic or genetic markers.Methods: All patients diagnosed with an eosinophilic gastrointestinal disorder (EGID) over a period of 39 months were entered into a clini-cal database after obtaining written consent. Only patients who had 20 or more eosinophils per high power field were included in the analysis of EoE, all of whom had undergone upper endoscopy with multiple biop-sies during the course of evaluation for a variety of digestive symptoms by a single endoscopist. Demographics, symptoms, results of available celiac and IBD serology and celiac-related HLA DQ genetics were analyzed and compared to historical normals in the general U.S. population using Chi square testing.Results: Between January 2006-March 2009, 52/84 EGID subjects had biopsy confi rmed Eosinophilic Esophagitis (EoE). Th e mean age of the cohort were: men 39.2 (range 17-86) and women 41.4 (range 17-77). Th e most common presenting symptom was dysphagia; followed by diarrhea, and epigastric pain/dyspepsia (Table 1). Celiac serology was available in 30/56. AGA IgG positive in 37% (p= 0.0005), AGA IgA in 20% (p= 0.012), EMA and tTG in 7% (Table 2). Of 19 tested for HLA DQ-related celiac genetics, 5 were DQ8 positive (26%, p=0.049). IBD related antibodies were observed in those tested (Table 2). Th e mean number of eosinophils in the distal esophagus was 39/HPF. Ten patients (19%) had 20 or more mast cells/HPF in duodenal biopsies (Table 1) but the mean number of IEL’s was not elevated despite increased prevalence of increased AGA and HLA DQ8.Conclusion: In adults, EoE occurs in a broad age range, including advanced elderly, but is slightly more common in men than women. Th ough dysphagia and heartburn/refl ux are the most common presenting symptoms, atypical symptoms of diarrhea and epigastric abdominal pain/dyspepsia are common. Being HLA DQ8+ or DQ2+, having an elevated AGA or an elevated IBD related antibody should prompt esophageal and duodenal biopsies, including tryptase stains.

39

Esophageal Motility Disorders are Uncommon in Eosinophilic EsophagitisFouad Moawad, MD, Jason Lake, MD, Corinne Maydonovitch, BS, Ganesh Veerappan, MD, John Bassett, MD, Roy Wong, MD, FACG. Gastroenterology, Walter Reed Army Medical Center, Washington, DC.

Purpose: Adult patients with eosinophilic esophagitis (EoE) present with a spectrum of clinical symptoms, of which dysphagia is the most common. Pre-vious studies have suggested that the mechanism of these symptoms may be related to esophageal motility disorders. Th e aim of this study was to evaluate EoE patients for esophageal manometric abnormalities.Methods: A retrospective chart review of esophageal manometry studies performed in adult EoE patients was conducted. EoE was defined as a clini-copathologic entity with peak esophageal eosinophils ≥15 per hpf. Esopha-geal motility was evaluated with 10 wet swallows (5 cc bolus). Manometric tracings were reviewed for motility abnormalities including (a) nutcracker esophagus (mean amplitude ≥200 mmHg), and (b) ineffective swallows. Ineffective swallows were defined as having either low amplitude peristal-tic (<30 mmHg) or non-propagating contractions. Ineffective esophageal motility (IEM) was categorized as mild (30-40% ineffective swallows), moderate (50-60% ineffective swallows), or severe (≥70% ineffective swallows).Results: Manometric studies of 64 adult EoE patients were reviewed (84% male, 81% white, mean age 41 years). Th e presenting symptom included dysphagia (71.9%, n=46), food impaction (9.4%, n=6), heartburn (10.9%,

Table 2. Celiac-related HLA DQ genetics and serology in eosinophilic esophagitis

Celiac-related HLA DQ Genetics 37 % ( n =19)

HLA DQ2 + 42 % ( n =8) Expected 25 – 30 % P =0.12 – 0.29 NS

HLA DQ8 + 26 % ( n =5) Expected 10 % P = 0.049*

Celiac Serology 58 % ( n =30)

AGA IgA + 20 % ( n =6) Expected 4 % P =0.012*

AGA IgG + 37 % ( n =11) Expected 10 % P =0.0005*

Celiac Serology Any test + 50 % ( n =15)

tTG IgA + 7 % ( n =1) Expected 1 % P = 0.97 NS

EMA IgA + 7 % ( n =1) Expected 1 % P = 0.97 NS

Limited IBD Serology Performed 12 % ( n =6)

ASCA + 44 % ( n =4) Expected 1 – 7 % P =0.0001 – 0.002*

pANCA + 11 % ( n =1) Expected 1 – 3 % P = 0.39 – 0.76 NS

Expanded (pro-metheusIBD7) Serology performed 5 % ( n =3)

cBIr1 + 67 % ( n =2) Expected 8 % P = 0.11**

OmpC + 33 % ( n =1) Expected 5 % P = 0.41 NS**

Chi Square testing performed to compare to expected based on historical prevalence in US. **Statistics for cBIr1 and OmpC limited by small numbers.

Table 1. Demographics, symptoms & histology in eosinophilic esophagitis

Age & gender n =56

Male / men 56 % ( n =29) Range 17 – 86

Female / women 44 % ( n =23) Range 17 – 77

Age range (all patients) 17 – 86

Esophageal symptoms

Dysphagia 46 % ( n =24)

Refl ux 31 % ( n =16) Chest pain 6 % ( n =3)

Upper abdominal symptoms

Dyspepsia 23 % ( n =12)

Gas-Bloat 17 % (n-9) Epigastric pain 25 % ( n =13)

Altered bowel pat-tern & GI bleeding

Diarrhea 25 % ( n =13)

Constipation 2 % ( n =1)

Occult blood in stool 6 % ( n =3)

Other symptoms

Nausea / vomiting 13 % ( n =7)

Weight Loss 4 % ( n =2)

Malabsorption 2 % ( n =1)

Esophageal and duodenal histology

Eosinophils mean 39 / hpf Range 20 – 130 / hpf

Mast cells elevated in duodenum 19 % ( n =10)

IEL’s / 100 duodenum Mean 13 / 100

Symptoms include all that were reported by patients. Eosinophils reported as mean / hpf of distal esophageal biopsy. Mast cells reported are those with an elevation 20 or more / hpf on tryptase immunohistochemistry stains and mean IEL’s per 100 enterocytes in duodenum on H & E stains.

Eosinophilic esophagitis.

Am J Gastroenterol 2009; 104:S16–S36; doi:10.1038/ajg.2009.492

© 2009 by the American College of Gastroenterology The American Journal of GASTROENTEROLOGY

Abstracts S17

n=7), or dyspepsia (7.8%, n=5). IEM was identifi ed in 20 patients (31.3%) and categorized as mild (17.2%, n=11), moderate (9.4%, n=6), and severe (4.7%, n=3). Nutcracker esophagus was found in 3.1% (n=2) of patients. In patients with dysphagia or food impaction, the majority (67.3%) demonstrated normal esophageal motility while 13.5% demonstrated moderate or severe IEM, and 1.9% demonstrated nutcracker esophagus.Conclusion: To date, this is the largest cohort of EoE patients evaluated for esophageal dysmotility. In this study, the majority of patients had normal esoph-ageal motility. In fact, only 13.5% of patients with dysphagia or food impaction displayed moderate to severe IEM. Esophageal motility disorders are uncom-mon in EoE and are unlikely to be a major contributing factor to symptoms.

40

Insights Gained From the Symptomatic Evaluation of Classifi cation of Esophageal Motility Disorders: A Review of 4215 PatientsKazuto Tsuboi, MD,1 Rebecca Welch, RN,1 Andràs Legner, MD,1 Fumiaki Yano, MD,1 Charles Filipi, MD,1 Ronald Hinder, MD,2 Tommy Lee, MD,1 Tom DeMeester, MD, FACG,3 Sumeet Mittal, MD1. 1. Surgery, Creighton University Medical Center, Omaha, NE; 2. Mayo Clinic, Jacksonville, FL; 3. University of Southern California Keck School of Medicine, Los Angeles, CA.

Purpose: Achalasia (Ach), diff use esophageal spasm (DES), nutcracker esoph-agus (NC), and non specifi c motility disorder (NSMD), are described primary esophageal body motility disorders. Th e relationship between manometric diagnosis and clinical symptoms is poorly understood. Th e aim of this study is to examine the correlation between patient’s presenting symptoms and mano-metric fi ndings.Methods: Manometric findings and reported symptoms of all patients undergoing esophageal manometry and pH studies at the Creighton Univer-sity Medical Center were prospectively entered in a database. Twenty-four year data was accessed and analyzed to understand symptom correlation.Results: Of the 4215 patients, 130(3.1%) had Ach, 192 (4.6%) had DES, 290 (6.9%) had NC, 508 (12.1%) had NSMD and 3095 (73.4%) had normal esophageal body motility. Th ere is signifi cant symptom overlap between the groups. Th e pattern of symptom distribution is similar in patients with Ach and DES with dysphagia correlating with increasing simultaneous waves. Patients with NC, normal body motility and NSMD predominantly presented with refl ux symptoms. Twenty-four hour pH score and refl ux associated symp-toms are inversely related to the LES competence.Conclusion: Symptoms and manometric diagnosis do not correlate well on an individual basis. Achalasia- DES seem to be part of the same clinical spectrum. Lower esophageal sphincter competence plays an important role in preventing gastro-esophageal refl ux. Treatment of GERD and its related esophageal body motility disturbances should be directed at restoring LES competence.

41

Incidence of Esophageal Cancer in Non Dysplastic Barrett’s Esophagus (NDBE) Has Been Overestimated, May be Related to GTH of Barrett’s Esophagus (BE) and is 10% of Non Esophageal Mortality: A Meta-AnalysisTusar Desai, MD, Jashant Singh, MD. William Beaumont Hospital, Bloomfi eld Hills, MI.

Purpose: We have systematically reviewed studies describing the incidence of esophageal adenocarcinoma in non dysplastic Barretts’ Esophagus(NDBE) and have found many errors in prior meta-analyses. Th e mortality rate from non-esophageal causes has been provided in many studies and this mortality data has not been analyzed in prior meta-analyses.Methods: Th e articles included by Wani (Amer J Gastro 2009) were reviewed, with attention to baseline age, dysplasia status, length of BE and non-esopha-geal mortality. In addition, a Medline search was performed for other stud-ies reporting the incidence of adenocarcinom in BE, and the list of references of review articles was searched to fi nd other studies that might have been missed.

Results: Three articles were eliminated from Wani’s meta-analysis because they represented redundant data presented by the same authors in other articles in the meta-analyis. Four additional articles not included in Wani’s meta-analysis were found and included in our meta-analysis. Review of the articles in Wani’s meta-analysis showed that cancer occuring from dys-plastic Barretts was included in the calculation of the incidence of cancer from NDBE. After eliminating redundant studies, including studies not previously analyzed, and correcting for baseline dysplasia status, we have found the incidence of cancer to be 148 cases over 35,600 patient years; representing a cancer incidence of 0.41% per year. The mean age of the population was 59+/–5years. The mean length of BE segment was provided in 26 studies, and was 5.2+/–2.8 cms. In 9 studies, only long segment BE was included. 7 of the studies were from a VA population, and VA patients accounted for 16% of all patients. 10 studies provided separate analysis of the incidence of esophageal cancer among patients with short segment BE. Pooled data from these studies showed that 4 patients developed adeno-carcinoma from short segment NDBE over 1793 patient-years follow up for an annual incidence of 0.2%/year. Non-esophageal mortality data was presented in 16 studies; which included 12,213 patient years, 48 cancers occurred for an incidence of 0.4% a year. However, there were 479 non-esophageal deaths over 12,213 patient years f/u for a mortality of 3.9% per patient year follow-up.Conclusion: Th e incidence of esophageal cancer in patients with NDBE is 0.41% a year. Th is is in patients with mean length of BE of >5 cms and a mean baseline age of 59 years. A large segment of patients were derived from the VA system. Th e risk of cancer in short segment NDBE is only 0.2%a year. Th e overall non-esophageal mortality in NDBE is 3.9% a year, almost 10 x higher than the cancer risk. Surveil-lance and possible ablation strategies must be evaluated in light of these fi ndings.

42

Evaluation of the Eff ect of Arbaclofen Placarbil, a Novel Transported Pro-drug of R-Baclofen, on Cardiac Repolarization in a Th orough QT Study in Healthy SubjectsDan Chen, MD, PhD, Ritu Lal, PhD, F. Jacob Huff , MD, Juthamas Sukbuntherng, PhD, Wendy Luo, MS, James Tovera, BS, Judy Ho, BS, Nora Cavazos, MD, Daniel Bonzo, PhD, Kenneth Cundy, PhD. XenoPort, Inc., Santa Clara, CA.

Purpose: Arbaclofen Placarbil (AP) is a novel Transported Prodrug of the refl ux inhibitor R-baclofen, and is under investigation for the treatment of symptomatic gastroesophageal refl ux disease (GERD) in patients who remain symptomatic on proton pump inhibitors. Th e purpose of this study was to assess the eff ect of steady-state oral dosing of AP on cardiac repolarization (QTcF interval duration) in healthy subjects.Methods: In this randomized, double-blind, double-dummy, placebo- and active-controlled parallel group study, 199 subjects were randomized to receive sustained-release AP treatment, moxifl oxacin (active control) treatment or placebo treatments. Subjects randomized to AP treatment were titrated in escalating doses over 19 days and steady-state levels of AP/R-baclofen were reached on Days 7, 13 and 19 at doses of 30 mg BID, 60 mg BID and 90 mg BID, respectively. Subjects randomized to the moxifl oxacin treatment arm received a single 400-mg dose of moxifl oxacin on Days 7, 13 and 19. Continuous Holter electrocardiograms (ECG) were collected at baseline (Day -1) and on Days 7, 13 and 19. Steady-state AP/R-baclofen and single-dose moxifl oxacin con-centrations were determined using LC/MS/MS methods. Th e primary analysis was on baseline-adjusted QTcF interval using a repeated measures ANCOVA model. Assay sensitivity using moxifl oxacin was analyzed on prospectively specifi ed time points using a hierarchical stepwise testing procedure.Results: Th e baseline-adjusted LS mean change in QTcF (ddQTcF) between AP and placebo treatment from 0.5 to 21 hours post morning dose ranged from 0.5 to 3.8 msec at 30 mg BID, 0.7 to 3.4 msec at 60 mg BID and 0.2 to 3.5 msec at 90 mg BID. Th e largest one-sided 95% CI upper bound for mean ddQTcF was 7.0 at 30 mg BID and 6.9 msec at 60 mg BID and 90 mg BID, all within 10 msec. No subject had a QTcF >480 msec or changes in QTcF from baseline >60 msec. No relationship was detected between ddQTcF and AP/R-baclofen concentrations. Assay sensitivity was established by demonstrat-ing the moxifl oxacin QT prolongation eff ect. No dose of AP investigated was

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age 41 yrs; range 21-59 yrs) were enrolled in the study. Overall, there was reasonable agreement between the Restech and Sandhill devices during simultaneous pH monitoring: 1) 96% of recordings agreed to within ±1.0 pH unit, and 2) 71% of recordings agreed to within ±0.5 pH units. The greatest divergence between the two devices occurred when: 1) the pH was around 4 (Restech detected more events), or 2) early in the morning when in the supine position.Conclusion: 1) At pH values of 4 and 5, the Restech Dx-pH probe is more accurate and/or faster to reach equilibrium. 2) More acidic refl ux is detected by the Restech probe at pH 4, 5 or 6. 3) Th e role of this device in extraesophageal GERD awaits ongoing studies.Disclosure: Dr Michael F. Vaezi, MD FACG - Research Support, Consultant, Restech Corporation.Th is research was supported by an industry grant from Restech Corporation.

44

Results of Esophageal pH-Multichannel Intraluminal Impedance (MII) Testing at a Tertiary Care Center Demonstrate High Rates of Persistently Abnormal Esophageal Acid Exposures on Acid Suppressive Th erapyRyan Madanick, MD,1 Serena Ezzedine, MD,2 Evan Dellon, MD, MPH,1 Sima Patel, MD,2 Douglas Morgan, MD, MPH,1 Nicholas Shaheen, MD, MPH1. 1. Division of Gastroenterology & Hepatology, UNC School of Medicine, Chapel Hill, NC; 2. UNC Hospitals, Chapel Hill, NC.

Purpose: pH-MII testing has rapidly gained favor as the test of choice for evaluating patients with symptoms suggestive of gastroesophageal refl ux disease (GERD), especially in those patients who do not respond to typical therapy for GERD. In controlled studies of patients receiving high-dose acid suppression, approximately 5-10% of patients have persistent acid refl ux, 30-40% have persistent non-acid refl ux, and 50-65% have no signifi cant refl ux. However, the outcomes of pH-MII testing in clinical practice have not been adequately defi ned. Th e aim of this investigation is to assess the outcomes of pH-MII testing in an open-access motility lab at a large tertiary care center.Methods: Data from all pH-MII studies performed since 2006 were abstracted. Studies were classifi ed as abnormal acid (% time pH <4≥ 4.2% total, 6.3% upright or 1.2% supine off acid suppression; 1.3%, 1.5%, or 0.5%, respectively, on acid suppression), abnormal nonacid (≥73 refl ux events with normal acid exposures off acid suppression; ≥ 48 events with normal acid exposures on acid suppression), hypersensitivity (normal acid exposures, normal number of refl ux events, symptom index ≥ 50% for primary symptom), negative (normal acid exposures, normal number of refl ux events, symptom index < 50% for primary symptom) or failure (study not interpretable due to probe failure or brief duration). Data were stratifi ed by age group and treatment status.Results: 393 studies were performed in 375 patients (154 M/221 F; age 1 mo-87.7 yr) between Feb 2006 and Oct 2008. At the time of initial study, 41 pts (11%) were ≤1 yo (infants), 69 (18%) were 1-17 yo (children), and 265 (71%) were ≥18 yo (adults). Among all pts who were being treated with acid-sup-pressive therapy, 46% of studies showed abnormal esophageal acid exposures, 13% showed signifi cant non-acid refl ux only, 7% showed hypersensitivity, 33% were negative, and 2% of studies failed. Th is distribution was similar across age

associated with cardiac dysrhythmia, morphology changes, cardiogenic syn-cope or seizures. AP was well absorbed and rapidly converted to R-baclofen. R-baclofen exposures were proportional to AP dose over the dose range stud-ied. Steady-state levels of intact prodrug in blood were low. Th e most com-monly reported treatment-emergent adverse events were dizziness, nausea, headache, insomnia, somnolence and vomiting, and were of mild or moderate intensity. No clinically signifi cant changes in vital signs, safety ECG or labora-tory values associated with AP treatment were observed.Conclusion: AP does not have an eff ect on cardiac repolarization at doses up to 90 mg BID.Disclosure: All authors are employees of XenoPort, Inc.Th is research was supported by an industry grant from XenoPort, Inc.

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Th e New Restech Dx-pH Probe for GERD: in Vitro and in Vivo ValidationNizar Mukhtar, MD,1 Milton Ochieng’, MD,1 Marion Goutte, BSc,1 James Slaughter, PhD,2 Michael Vaezi, MD, FACG1. 1. Digestive Disease Center, Vanderbilt University Medical Center, Nashville, TN; 2. Vanderbilt University School of Medicine, Nashville, TN.

Purpose: Th e Restech Dx-pH probe was recently introduced as a more sensitive tool for the detection of GERD. However, there are no studies systematically assessing its performance characteristics compared to the cur-rent standard. Th e aims of this study were: 1) To compare test performance of the Restech Dx-pH and Sandhill probes at pH 1-7 in both the liquid and vapor phases, and 2) evaluate probe sensitivities in the clinical setting in patients with GERD.Methods: In vitro liquid/vapor phase - Simultaneous pH measurements using the Restech Dx-pH and Sandhill probes were obtained following their immersion in buff er solutions of pH 1-7 for 5-minute intervals (liq-uid phase). Additionally, using an ultrasonic vaporizing unit, the probes were exposed to aerosolized buff er solutions of pH 1-7 (vapor phase). Th e accuracy of pH measurement (deviation from target pH) and time taken to achieve equilibrium pH was determined for each probe. Probe perfor-mance in clinical setting - Simultaneous ambulatory 24-hour pH monitoring using the Restech Dx-pH and Sandhill probes was performed in patients with GERD (prior response to H2RAs or PPIs and/or history of endoscopic esophagitis). Probes were positioned 5cm above the manometric LES. Th e number of events and percentage of time spent below pH 4, 5, and 6 was determined.Results: In vitro liquid/vapor phase - At all pH values, the Sandhill probe underestimated the true pH by a median (25%-75%) of 0.50 (0.30-0.60) pH units, while the Restech probe slightly overestimated the true pH [0.00 (-0.38-0.45)]. In the liquid phase, the Restech probe had less deviation from the solution pH at pH ≤ 5. Deviation from target pH in the vapor phase was similar for the two probes (0.4 pH units). Median (25%-75%) time to reach equilibrium pH (seconds) was signifi cantly (p< 0.001) faster with the Restech than the Sandhill probe [liquid phase: 5.5 (2.5-11.0) and 21.0 (3.5-45.5); vapor phase: 16.5 (3.0-34.5) and 57.0 (30.5-75.0); respectively]. Probe performance in clinical setting - Eleven patients (45% male; mean

[44] Table 1 . Distribution of study results by age group and treatment status

Age group # of studies Abnormal acid Abnormal non-acid Hypersensitive Negative Failure

Infants On tx ( n =26) 11 (42 % ) 7 (27 % ) 0 (0 % ) 6 (23 % ) 2 (8 % )

Off tx ( n =16) 9 (56 % ) 0 (0 % ) 4 (25 % ) 1 (6 % ) 2 (13 % )

Children On tx ( n =29) 16 (55 % ) 2 (7 % ) 0 (0 % ) 8 (28 % ) 3 (10 % )

Off tx ( n =45) 15 (33 % ) 1 (2 % ) 5 (11 % ) 21 (47 % ) 3 (7 % )

Adults On tx ( n =153) 68 (44 % ) 17 (11 % ) 14 (9 % ) 54 (35 % ) 0 (0 % )

Off tx ( n =124) 52 (42 % ) 5 (4 % ) 12 (10 % ) 51 (41 % ) 4 (3 % )

Overall On tx ( n =208) 95 (46 % ) 26 (13 % ) 14 (7 % ) 68 (33 % ) 5 (2 % )

Off tx ( n =185) 76 (41 % ) 6 (3 % ) 21 (11 % ) 73 (39 % ) 9 (5 % )

© 2009 by the American College of Gastroenterology The American Journal of GASTROENTEROLOGY

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groups (Table 1). Among those pts who were receiving high-dose acid sup-pression, defi ned as at least twice daily proton pump inhibitor (PPI) therapy, a similar distribution was seen (Table 2).Conclusion: In an open-access motility lab at a large tertiary care center, there was a markedly higher percentage of studies with persistently abnormal acid exposure among patients receiving acid suppressive therapy than has tradi-tionally been reported in controlled studies.

45

Impedance pH Confi rms the Relationship Between GERD and BMINasser Hajar, MD, Arsen Zacharian, MD, Nazif Chowdhury, MD, Richard Rackett, LNP, Amine Hila, MD. United Health Services, Johnson City, NY.

Purpose: Background: Th e prevalence of both gastroesophageal refl ux disease (GERD) and obesity has been increasing over the last 40 years in the United States. Although the pathophysiology of GERD is multifactorial, its relation-ship with obesity is still incompletely understood. Multiple previous studies showed increased acid refl ux in patients with higher body mass index (BMI). Aim: To evaluate the association between BMI and refl ux as detected by multi-channel intraluminal impedance and pH (MII-PH) monitoring.Methods: Retrospective review of 122 consecutive MII-pH studies of adult patients: 85 females, mean age = 49 years, data was collected between 11/2006 and 02/2009. BMI was calculated for each patient based on height and weight at the time of MII-pH study. Patients were divided in 3 groups: normal (BMI <25), Overweight (BMI 25-30) and Obese (BMI >30). We evaluated the associ-ation between refl ux and diff erent BMI groups by using number of acid refl ux (AR), non acid refl ux (NAR) and total number of refl ux episodes, as detected by MII-pH. All MII-pH studies were done while patients were on once or twice a day Proton Pump Inhibitor (PPI) therapy.Results: Mean number of refl ux episodes reported in table below:(see table) Patients had a statistically signifi cant higher number of total refl ux episodes and NAR as their BMI increased: p=0.012 and p=0.036 respectively (Kruskal-Wallis test). Th ere was no signifi cant diff erence between groups in AR (p=0.5, Kruskal-Wallis test). Th is is most likely due to the very low incidence of AR in these patients tested while on PPI therapy.Conclusion: Th is study shows a clear association between increased refl ux as detected by MII-PH and higher BMI.

46

Esophageal Food Impactions and the Prevalence of Eosinophilic EsophagitisPreston Jones, MD, John Long, MD. Internal Medicine, Wake Forest University Baptist Hospital, Winston-Salem, NC.

Purpose: Esophageal food impactions are the third most common cause for nonbiliary emergent endoscopy with rings, webs, and strictures being the

primary causes. However, eosinophilic esophagitis (EE) appears to be an emerg-ing cause. Th is study aims to determine the incidence of both food impactions and EE at North Carolina Baptist Hospital over the last 5 years and to determine etiologies of impactions, epidemiology, risk factors, and seasonal patterns. Methods: Th e study is a retrospective chart review including patients >18 years old requiring emergent EGD secondary to food impactions. Th e data collected included age, gender, race, time interval from onset, time/day/month of presen-tation, location and etiology of impaction, method and success rate of removal, complications, and dilations/biopsies that were performed. Results: Data was collected from 1/04 to 9/08 with 159 charts being reviewed. 135 patients were included with 76 being >50 yo and 59 being <50 yo (1.29: 1). Male to female ratio was 1.41: 1. Th ere were 79 males with 42 being >50 yo and 37 being <50 yo (1.1: 1). Th ere was a total of 56 females with 34 being >50 yo and 22 being <50 yo (1.5: 1). 90% (121 pts) were Caucasian and 10% (14) were African American. Incidence per year is as follows: 2004, 24 pts; 2005, 17 pts; 2006, 37 pts; 2007, 24 pts; and 2008 (only 9 months), 33 pts. Th e most common month of presentation was June (20) with January-March having 33, April-June 43, July-September 36, and October-December 23. Most occurred over the weekend with 76 pts presenting Friday-Sunday while 59 presented Monday-Th ursday. Distribution among time of day was equal with 69 pts presenting between 0600-1800 while 66 pts presented between 1800-0600. Success rate for removal of impaction was 92%. Th e type of food varied with beef being most common (32%), then chicken (20%), pork (15%), and other (9%). 25% were not documented. Causes for impactions were rings/webs (38%), unknown (33%), strictures (19%), and EE (10%). Only 34 biopsies were taken, 14 being positive for EE which accounted for 41% of the total biopsies. Conclusion: Th e incidence of food impactions was higher in males compared to females (1.41: 1), consistent with previous studies. Th ere did not appear to be a tem-poral component. Only 10% of the cases were documented EE, but EE accounted for 41% of the biopsies taken. Since EE can present with rings, webs, and strictures, and since only 25% of the cases were biopsied, it is likely that the actual incidence is much higher. Th erefore, in the future, more biopsies should be performed in patients with impactions to rule out EE even in the presence of rings, webs, or strictures since the treatment of EE is completely diff erent than the others.

47

Predictors of Overall Survival in a Large Population Based Barrett’s Esophagus Cohort

2009 ACG/Governor’s Award for Excellence in Clinical ResearchGanapathy Prasad, MD, MS, Kenneth Wang, MD, Yvonne Romero, MD, Nicholas Talley, MD, PhD, Giles Locke, MD, Cathy Schleck, MS, Alan Zinsmeister, PhD, Kelly Dunagan, BS, Mary Frederickson, CCRP, Debra Geno, CCRP, Lori Lutzke, LPN, Lynn Borkenhagen, MS, NP, Ngozi Okoro, MD. Mayo Clinic, Rochester, MN.

Purpose: Data on the infl uence of BE on overall survival is confl icting with both increased and unaff ected mortality being reported in cohort studies. Surveillance has been proposed to detect progression to HGD/esophageal adenocarcinoma (EAC) with the aim of improved survival. However, data to support this strategy is limited. We aimed to 1) Estimate the overall survival of a population based BE cohort in Olmsted County, MN and compare this to that expected. 2) Assess the association of “surveillance state status” (under surveillance vs. not) with overall survival.Methods: All patients with a diagnosis of BE (endoscopically visible colum-nar mucosa: at least 1 cm long, with histologic evidence of intestinal meta-plasia) from 1977-2006 were identifi ed using the Rochester Epidemiology

[44] Table 2 . Distribution of Study results by age group among pts on high-dose acid suppression

Age group # of studies Abnormal acid Abnormal non-acid Hypersensitive Negative Failure

Infants 18 6 (33 % ) 7 (39 % ) 0 (0 % ) 3 (17 % ) 2 (11 % )

Children 19 11 (58 % ) 2 (11 % ) 0 (0 % ) 5 (26 % ) 1 (5 % )

Adults 119 55 (46 % ) 14 (12 % ) 11 (9 % ) 39 (33 % ) 0 (0 % )

Overall 156 72 (46 % ) 23 (15 % ) 11 (7 % ) 47 (30 % ) 3 (2 % )

Mean number of refl ux episodes

BMI Total refl ux NAR AR

< 25 41.67 33.60 8.06

25-30 51.56 36.86 14.07

>30 65.96 52.74 14.10

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Project (REP) resources in Olmsted County and confi rmed via review of medical records. Survival data and cause of death was ascertained from medi-cal records and Minnesota Death Tapes. Overall survival was compared to that expected (MN Whites) based on the age and gender distribution of the cohort. Th e association of demographic factors, comorbidities, (assessed with the Charlson Comorbidity Index), surveillance status state (time dependent covariate) and baseline histology were assessed using a Cox proportional haz-ards regression model.Results: 401 subjects were included and 287 (72%) were males. Mean (SD) age was 63 (14) yrs. Patients with EAC at diagnosis or within 6 m of diag-nosis of BE were excluded. Overall survival at 10 years was 68% (95% CI: 62,75). Causes of death were cardiac in 22, esophageal cancer in 5 and other in 64. Overall survival in the cohort versus that expected is shown in Figure 1. Survival in the BE cohort was not signifi cantly diff erent from that expected (p=0.16, log rank test). Estimated hazards ratios of variables assessed are given in Table 1. Surveillance status state was not associated with overall survival.Conclusion: In contrast to earlier studies, the overall survival of this large population based BE cohort was comparable to that expected. Endoscopic sur-veillance does not appear to infl uence overall survival, which was associated with age and comorbidities.

48

Nausea and Cough May Be Inducing Refl ux in Some PatientsNasser Hajar, MD, Arsen Zacharian, MD, Richard Rackett, LNP, Amine Hila, MD. United Health Services, Johnson City, NY.

Purpose: Introduction: In multichannel intraluminal impedance and pH (MII-pH) monitoring, symptom association with refl ux is an important part of the diagnostic component of the test. Th is was traditionally looked at by

using either symptom index (SI), or Symptom association probability (SAP). Th e SI only takes into consideration refl ux occurring before a symptom, while SAP takes into consideration a 2 minute period around a refl ux episode. Aim: To assess frequency occurrence of MII-pH detected refl ux episodes before and aft er a reported symptom.Methods: Retrospective review of 126 consecutive adult patients (88 females; 40 males; means age 50.2 years). Data collected between 11/2006 and 02/2009. Presence of refl ux episodes within 5 minutes of any reported symptom was counted and then divided by total number of the same symptom for each patient. Th is allowed us to calculate an SI for 5 minutes before and 5 minutes aft er each symptom.Results: Th e table below shows p values comparing the 2 diff erent symptom indices: 5 minutes before and 5 minutes aft er the symptom, Th is data shows us that refl ux episodes occur more frequently before than aft er these symptoms: heartburn, indigestion, throat clearing, regurgitation and chest pain. However, for cough and particularly nausea, there is no statistically signifi cant diff er-ence for the likelihood of refl ux episodes to occur before rather than aft er these symptoms.Conclusion: Nausea and possibly even cough could be symptoms both causing refl ux and due to it. Th is data suggests that including time interval aft er a symp-tom in analyzing symptom association may be error inducing.

49

Self Dilation as a Treatment for Resistant Benign Esophageal Strictures: Outcome, Technique and Quality of Life AssessmentIvana Dzeletovic, MD, David Fleischer, MD, Michael Crowell, PhD, H. Jae Kim, MD, Lucinda Harris, MD, George Burdick, MD, Roxane McLaughlin, RN, Robert Spratley, RN, Virender Sharma, MD. Mayo Clinic Arizona, Scottsdale, AZ.

Purpose: Resistant benign esophageal strictures can have signifi cant and del-eterious eff ects on patients’ quality of life (QoL). A portion of these patients require frequent endoscopic dilations at medical facilities, leading to numerous interactions with their attendant inconvenience, risk, cost and sense of depen-dence. Few published articles discuss self dilation as a treatment for resistant benign esophageal strictures. Th is study demonstrates the effi cacy, safety and eff ect on QoL of this under utilized technique.Methods: A retrospective chart review was performed for all patients undergoing esophageal self dilation at our institution between January of 2003 and Novem-ber of 2008. Demographic and clinical information regarding relief of dysphagia, complications and frequency of endoscopic and self dilation respectively were abstracted. Th e impact on QoL was evaluated using a telephone questionnaire specifi cally designed to explore emotional, social and fi nancial impacts.Results: Of the 11 patients who initially began self dilation for non-malignant strictures, 9 are included in this study. Two patients failed attempts at self dila-tion due to anxiety. Mean age was 62 years (range 34-86 yrs). Etiologies of the strictures were: radiation therapy (n=3), fi brosis at anastomotic site (n=2), eosinophilic esophagitis (n=1), lye ingestion (n=2) and one patient had both radiation induced and peptic stricture. Th e average number of physician per-formed endoscopic dilations from the time of diagnosis to the time of initia-tion of self dilation were 23 (range 6-44). Median follow-up was 35.4 months (range 6-156). No signifi cant complications such as bleeding or perforation were reported. Six patients required endoscopic dilations aft er the initiation of self dilation. When asked to compare self dilation with endoscopic dilation, 75% (6/8) of patients reported fi nancial benefi ts, 75% (6/8) reported feeling less anxious and 62.5% (5/8) reported being more socially active. Overall QoL improvement was reported by 75% of the participants in the study. Global scores for dysphagia and overall QoL were signifi cantly improved under condi-tions of self dilation versus EGD dilation (p=0.008 and p=0.016, respectively).Conclusion: Our results suggest that esophageal self dilation can be a safe and effective treatment modality in motivated patients with benign resistant

Factors included in multivariable proportional hazards regression model for overall survival in a population based BE cohort ( N =338 without HGD / EAC at presentation)

Variable Hazard ratio (95 % CI) P value

Surveillance status 0.81 (0.55,1.18) 0.27

Age 1.04 (1.02, 1.07) 0.003

Male gender 0.95 (0.56, 1.62) 0.85

Low grade dysplasia 1.06 (0.62, 1.82) 0.84

High grade dysplasia 6.84 (2.12, 22.08) 0.001

Charlson comorbidity index 1.30 (1.20, 2.41) < 0.001

Kaplan Meier Curve of survival of BE cohort and expected survival of age and gender matched MN cohort.

Symptom Heart burn Cough Indigestion

Throat clearing

Regur-gitation Nausea

Chest pain

P value 0.0086 0.082 0.027 0.015 0.034 0.43 0.017

© 2009 by the American College of Gastroenterology The American Journal of GASTROENTEROLOGY

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esophageal strictures. Esophageal self dilation has a positive impact on emotional, social, and financial aspects of patient’s life. Improvements in overall health and QoL are substantial. Self dilation should be consid-ered as a treatment option in all patients with benign resistant esophageal strictures.

50

Report of Dysphagia Caused by “Fat Burners” and “Muscle Builders” OTC Tablets in Deployed TroopsLeon Kundrotas, MD, FACG,2 Patrick Storms, MD,1 Kevin Franklin, MD2. 1. 31st Medical Group, Aviano AB, Italy; 2. SAMMC-S, San Antonio, TX.

Purpose: U.S. forces while deployed have access to commercial dietary supplementation for use as fi tness aids. Seven cases of “large pill” induced dysphagia are reported in deployed U.S. military personnel from inges-tion of OTC “fat burners” and “muscle builders” tablets (Hydroxycut® and NaNOx9®).Methods: Over a one year period, 7 (age 20-35 yrs; all males) cases of odynophagia, dysphagia and pill-induced esophagitis were associated with recent ingestion of these substances. Endoscopic findings of all 7 were consistent with “pill esophagitis” or the pill actually being present on endoscopic exam. No impacted tablets required endoscopic removal. In all cases, the patient presented with symptoms of painful swallowing or obstruction soon after product ingestion. No underlying anatomic esopha-geal narrowing or previous history suggestive of a motility disorder was present in any of these young otherwise healthy active duty individuals. All cases were referred to the theatre hospital from forward operating bases in Iraq for treatment of suspect substance impaction and possible endoscopic management.Results: See Table below.Conclusion: Th e large pill size, number of tablets to be ingested per product recommendations (minimal 3 caplets BID; advance to 5 caplets BID just prior to workout) and rapidity of ingestion challenges the known areas of physiologic esophageal narrowing in normal individuals. Product instruction recommends taking these aides just prior to the workout. Bench pressing in the supine posi-tion is part of many of the weight lift ers’ routine work out. Th e muscle builder by assuming a supine position immediately aft er rapid ingestion of these large caplets (3-5 caplets) in an arid environment, with inadequate fl uid ingestion, may contribute to the pill’s delay in esophageal passage in normal individuals and cause subsequent symptoms. Specifi c inquiry into the ingestion of the size, amount and method of intake of one these products may help defi ne the etiol-ogy of symptoms in a known body builder or one with recent use of these OTC supplemental tablets into their exercise routine. Some of these products exist in a powder form to be mixed with water as an alternative form for intake. Educa-tion on the proper ingestion of these large tablets may avoid obstruction and “pill esophagitis.”

51

Management of Benigh Esophageal Strictures via Rendezvous Procedure: A Case SeriesLisa Patel, MD, Michael Demyen, MD, FACG, Nitin Patel, MD, Rajat Parikh, MD, Mark Sterling, MD, FACG, Soly Baredes, MD, Eric Cohen, MD. UMDNJ-NJ Medical School, University Hospital, Newark, NJ.

Purpose: To describe the eff ectiveness of the novel rendezvous procedure and illlustrate its potential to signifi cantly increase patients’ quality of life.Methods: Retrospective review of seven patients treated with esophageal ren-dezvous procedure from Jan 2006-April 2009.Results: 5 out of 7 patients had positive outcomes. 1 patient had complications of esophageal microperforation.Conclusion: Refractory benign esophageal strictures present unique chal-lenges. Th is case series demonstrates the rendezvous procedure could be an eff ective treatment option with minimal adverse eff ects.

Product # Cases Tablet size Comment

Motrin 800 mg tab 20 mm For size reference

Hydoxycut ® 3 20 mm Weight loss supplement \ “ fat burner\ ”

NaNOx9 ® 4 22 mm Strength supplement \ “ muscle builder\ ”

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52

Photodynamic Therapy versus Radiofrequency Ablation Therapy in Barrett’s Esophagus with DysplasiaIrum Zaheer, MD,1 Atilla Ertan, MD,MACG, FACG,1 Alberto Barroso, MD, FACG,1 Shanda Blackmon, MD,2 Arlene Correa, Statistician2. 1. Gastroenterology Department, Th e Methodist Hospital, Houston, TX; 2. Surgery Department, Th e Methodist Hospital, Houston, TX.

Purpose: Various endoscopic modalities for managing Barrett’s dysplasia (BD) are available and no previous comparison of the photodynamic therapy (PDT) vs. radiofrequency ablation therapy (RFT) exists. Th e aim of this study is to com-pare these modalities with regard to endoscopic eradication (EE) of Barrett’s metaplasia (BM) and BD, adverse events, and costs from a single institution.Methods: Prospectively collected data of consecutive patients were used to identify 88 patients with BM and BD who underwent PDT vs. RFT. All PDT patients had high grade dysplasia (HGD) and either refused surgery or were

not considered surgical candidates. Eleven (18%) RFT patients had HGD while others had low grade dysplasia (LGD). Th irty-four patients with BD received PDT and 62 patients with BD underwent RFT with HALO-360 and -90 sys-tems. Combined modalities were performed in 8 patients at diff erent times (PDT prior to RFT in all cases).Results: Th irty-one PDT patients (91%) and 46 (74%) RFT patients were men. Th e mean age was 70.2±12.2 and 66.2±13; the mean length of BM was 5.7±3.3 cm & 5.4±3.1 cm for PDT and RFT patients, respectively. Th e EE of BD was (25/34) 73.5% with PDT vs. (55/62) 88.7% with RFT aft er the completion of fi rst endo-scopic ablation treatment (p=0.06). Th e EE of BM was present in (15/34) 44.1% of PDT vs. (42/62) 67.7% RFT patients, (p=0.03). Th ese EE ratios were improved with subsequent additional ablation therapies. Th e EE of BD was (60/62) 96.8% with an additional HALO-90 touch-up. Post-PDT clinically signifi cant dyspha-gia was seen in 9 patients and managed with multiple endoscopic dilatations and in 2 of those cases needed endoscopic temporary stent. Two of post-RFT dysphagia patients were managed by endoscopic dilatation easily and both had

[51] Stricture characteristics and response

Stricture Location # Attempts Repeat dilations Response

Patient 1 Cricopharyngeal 18 CM 1 2 +

Patient 2 Cricopharyngeal 17 CM 1 1 +

Patient 3 Hypopharyngeal 14 CM 2 4 +

Patient 4 Complete closure of hypopharynx 14 CM 5 N / A −

Patient 5 Subcricoid, near total obstruction 4 CM 2 2 +

Patient 6 Hypopharyngeal 3 CM 2 0 +

Patient 7 Proximal, repeated Candida esophagitis Unsuccessful attempt N / A −

[51] Cancer history and treatment

Type of cancer Radiation Surgery Chemotherapy Time from initiation radiation to sx

Patient 1: 52M Tonsillar ca YES YES NO 5 MOS

Patient 2: 66M Pyriform sinus ca YES NO YES 4 MOS

Patient 3: 67M Sq cell ca of tongue YES NO YES 1 MONTH

Patient 4: 28F Laryngeal ca YES NO YES 4 MOS

Patient 5: 81M Sq cell ca of submental LN YES YES YES 3 MOS

Patient 6: 63M Supraglottic ca YES NO YES 5 MOS

Patient 7: 41F Recurrent Can dida esophagitis NO NO NO N / A

[51]

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also Parkinson’s disease. One patient with PDT had esophageal perforation who was managed with non-surgical measures and no perforation was seen in RFT patients. Th e subsquamous intestinal metaplasia was (4/34) 11.8% with PDT and (2/62) 3.1% with RFT treated patients. According to the calculated cost analysis in our institution, PDT was four times more costly than RFT.Conclusion: Both PDT and RFT can lead to satisfactory eradication of BD and BM. However, RFT management had less adverse events and less costly compared to PDT in patients with BD.Disclosure: Dr Ertan is receiving research grants, lecture & consultant fees from Abbott, Barrx Medical,Centocor, Eisai and UCB.

53

SI & SAP: Useful or Infl ated Importance?Jonathan Schneider, MD, Yasar Ishaq, BS, James Slaughter, PhD, Marion Goutte, BS, Michael Vaezi, MD, PhD, FACG. Vanderbilt University, Nashville, TN.

Purpose: SI (Symptom Index) and SAP (Symptom Associated Probability) are commonly employed indices in associating pt sx’s to refl ux during pH or impedance monitoring. However, neither index is based on outcome measures and they are oft en employed in tx refractory pt’s such as non-erosive or extra-esophageal groups. Surprisingly, the test characteristics for these indices have not been evaluated in “best case scenarios” such as esophagitis, the objective gold standard for GERD. Th erefore, we aimed to assess sensitiviy of sx asso-ciation indices as well as conventional pH parameters in a group of pt’s with erosive esophagitis who had undergone pH monitoring.Methods: Pts with suspected GERD underwent EGD and 48-hr-wireless pH monitoring off therapy aft er an overnight fast. Esophagitis was graded using LA classifi cation. pH data such as % time pH < 4, # of refl ux events for both day 1 & day 2 in the supine and upright periods were determined and SI and SAP calcu-lated. Sensitivity for each pH parameter was determined and compared. SI and SAP were considered positive if >50% and 95%, respectively. Abnormal % time pH<4 were determined for both values greater than 4.2% and 5.5% cutoff s.Results: 250 pts [Mean (range) age=64 (53-73), 26% male, 89% Caucasian) under-went EGD and wireless pH monitoring from 2006-2009. 36/250 (30%) pts had esophagitis (Grade A=48%, Grade B=28%, Grade C=17%; Grade D=7%) [mean (range) age=66 (56-76), 36% male, 88% Caucasian]; Predominant sx’s: HB (54%), cough (37%), and regurg (26%). Median (25%-25%) total % time pH <4 (average for the two study days)=10.5% (9.2%-14.2%). Figure 1 highlights the sensitivity for detecting disease in this group of known GERD pt’s: % time pH < 4 was the most sensitive measure; 86% (5.5% cutoff ) and 94% (4.2% cutoff ), total number of events=78%. SI & SAP had very low sensitivity, 45% and 35%, respectively.Conclusion: 1) In pts with GERD sx’s and esophagitis (“best case scenario”), we found that: a) % time pH <4 was the most sensitive parameter and b) SI and SAP have sensitivities less than 50%. 2) Our data questions the utility of symp-tom indices especially if used in a group of diffi cult to manage non-erosive or extraesophageal pt’s.

54

Cryotherapy for Barrett’s Esophagus and Early Esophageal Cancer: A Pooled Analysis of Cases from 1999-May 2009Emmanuel Gorospe, MD, MPH,1 Joyce Koh, MD,1 Alexander Mallari, MD,2 Kathleen Talamayan, MD, MPH3. 1. Johns Hopkins Bayview Medical Center, Baltimore, MD; 2. Rochester General Hospital, Rochester, NY; 3. University of Illinois Medical Center, Chicago, IL.

Purpose: Endoscopic spray cryotherapy is increasingly recognized to be eff ec-tive in ablating Barrett’s esophagus (BE) and early esophageal cancer (EEC). To summarize the current practice and effi cacy of cryotherapy for BE and EEC, we conducted a systematic literature review.Methods: We individually searched the literature (PubMed, EMBase, Web of Science, Cochrane, DDW and ACG meeting abstracts from 1999 to May 2009, bibliographies of selected articles). The search was limited to English publications, pilot studies and clinical trials with human partici-pants. We excluded studies on advanced esophageal cancer, cryotherapy combined with other ablative modalities and studies not reporting com-plete resolution (CR), defined as no histological evidence of BE or neo-plasia after treatment. We used the following search terms: cryotherapy, cryoablation, Barrett’s esophagus and esophageal cancer. Data from earlier reports by the same authors and study were pooled with their updated reports. Three independent reviewers determined eligibility for inclusion and extracted data.Results: We identifi ed no randomized clinical trials. Our search yielded 46 papers of which 8 met the inclusion criteria. Th ese were published from 2006 to April 2009 with a total of 222 enrolled patients (mean age 68.5 yrs; 50-87% male). All studies were prospective case series, with cryotherapy as either primary or rescue treatment for BE and EEC. Six abstracts reported aggregated data while two abstracts published individual patient data. All used spray cryotherapy with either liquid nitrogen (N2, n=7 studies) or car-bon dioxide (CO2, n=1). Four studies noted failed treatments before cryo-therapy with endoscopic mucosal resection being the most common (n=34 cases). All verifi ed histology by biopsy before treatment. Th ere were 8 cases of early squamous cell cancer combined with the majority of cases reporting BE, high grade dysplasia and intramucosal carcinoma. Studies that reported BE length had a mean of 4.4 cm. Cryotherapy was administered over 2-8 cycles for 10-20 seconds per area, with a mean of 4.3 sessions per patient. Overall, 63% of enrolled patients completed treatment. Th e mean CR was 74% (range: 48-94%). Th e case series with CO2 cryogen had the highest CR rate (94%). Transient abdominal discomfort was the most common side eff ect (n=28 cases). Strictures were the most common serious events (n=9 cases), requiring dilation in 4 patients.Conclusion: The current literature suggests that cryotherapy is a safe and effective modality for BE and EEC. Further research using random-ized trials is needed to establish efficacy, comparison with other modali-ties, optimal dosimetry and choice of cryogen (CO2 vs. N2) for better CR rates.

55

Can Eosinophilic Esophagitis be Diff erentiated From Gastroesophageal Refl ux Disease? A Clinicopathologic Case-Control Study with Predictive ModelingEvan Dellon, MD, MPH, Wood Gibbs, MD, Karen Fritchie, MD, Tara Rubinas, MD, Lindsay Wilson, MD, John Woosley, MD, PhD, Nicholas Shaheen, MD, MPH, FACG. University of North Carolina - Chapel Hill, Chapel Hill, NC.

Purpose: Because features of eosinophilic esophagitis (EoE) and gastroesoph-ageal refl ux disease (GERD) overlap, distinguishing them clinically can be challenging, and eosinophil counts alone do not suffi ce. Th e study aim was to characterize clinical, endoscopic, and histologic fi ndings in patients with EoE and GERD, and determine factors which diff erentiated the two groups of patients.Methods: We performed a retrospective case-control study from 2000-2007. Cases were patients of any age with a new diagnosis of EoE, as defi ned by consensus guidelines (≥15 eosinophils in at least one high-powered fi eld; at least one typical symptom of esophageal dysfunction (i.e. dysphagia, food

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impaction, chest pain, or heartburn); other causes of eosinophilia excluded; and lack of response to proton-pump inhibitor). Controls were patients of any age with GERD (at least one typical symptom; infl ammation on esopha-geal biopsy; and a clinical evaluation excluding other causes). Clinical and endoscopic data were collected, and esophageal biopsy specimens were re-assessed by GI pathologists. Cases and controls were compared, uncondi-tional logistic regression was performed to develop a model to predict EoE, and receiver operator characteristic (ROC) curves were constructed.Results: Data from 151 patients with EoE and 226 GERD patients were ana-lyzed. As compared to GERD patients, the key features that independently predicted EoE included: younger age; symptoms of dysphagia; documented food allergy; esophageal rings, linear furrows, and white plaques or exudates on upper endoscopy; the absence of a hiatal hernia on upper endoscopy; a higher maximum eosinophil count; and the presence of eosinophil degranula-tion on the biopsy specimen. Th e presence of heartburn and erosive esophagi-tis were not predictive. Th e area under the ROC curve for this model was 0.934 (see Figure). It was also reliable by regression diagnostic testing (i.e. Hosmer- Lemeshow goodness-of-fi t; bootstrap stepwise regression).Conclusion: In our cohort, a set of readily available and routinely measured variables reliably diff erentiated EoE from GERD. Although validation is neces-sary, applying this model to cases of suspected EoE may lead to more accurate diagnosis.

56

Progression of Symptoms and Endoscopic Findings with Age: Clues of the Natural History of Eosinophilic Esophagitis?Evan Dellon, MD, MPH, Wood Gibbs, MD, Karen Fritchie, MD, Tara Rubinas, MD, Lindsay Wilson, MD, John Woosley, MD, PhD, Nicholas Shaheen, MD, MPH, FACG. University of North Carolina - Chapel Hill, Chapel Hill, NC.

Purpose: Data concerning the natural history of eosinophilic esophagitis (EoE) are limited. Th e study aim was to determine if presenting symptoms and endoscopic fi ndings in a large cohort of EoE patients varied by age.Methods: We performed a retrospective study of our EoE database from 2000-2007. EoE patients were defi ned by consensus guidelines (≥15 eosino-phils in at least one high-powered fi eld; at least one typical symptom of esoph-ageal dysfunction (i.e. dysphagia, food impaction, chest pain, or heartburn); other causes of eosinophilia excluded; and lack of response to proton-pump inhibitor). Clinical and endoscopic data were collected, and esophageal biopsy specimens were re-assessed by GI pathologists. Symptoms and endo-scopic fi ndings at initial presentation were stratifi ed by age at the time of diagnosis.Results: Data from 151 patients with EoE were analyzed. Symptoms varied by age (Figure 1). Mean age for patients with failure-to-thrive, vomiting, abdomi-nal pain, and heartburn was 10, 15, 20, and 22, respectively. Mean age for food impaction and dysphagia was 29 and 31. Endoscopic fi ndings also varied by

age (Figure 2). Mean age for patients with white plaques, erythema, esophagitis and linear furrows was 13, 18, 23, and 24. Mean age for esophageal narrowing, strictures, and rings was 31, 35, and 37. Mean age at fi rst dilation was 35.Conclusion: Symptoms at presentation and initial endoscopic fi ndings in EoE vary with age. Younger patients display a more infl ammatory phe-notype, while older patients have one which is more fi brotic or stenosing, potentially implying that the natural history of EoE may have a similar pro-gression.

57

Narrow Band Imaging Highlights Endoscopic Findings in Eosinophilic EsophagitisEvan Dellon, MD, MPH, Ryan Madanick, MD, Nicholas Shaheen, MD, MPH, FACG. University of North Carolina - Chapel Hill, Chapel Hill, NC.

Purpose: Typical endoscopic findings in eosinophilic esophagitis (EoE) include rings, linear furrows, and white plaques or exudates. However, up to one-third of patients with EoE have been reported to have an endo-scopically normal esophagus. Because our clinical experience suggests that narrow band imaging (NBI) makes subtle findings more prominent, the aim of this study was to assess whether NBI highlights endoscopic findings in EoE.Methods: We performed a retrospective study of our EoE database from 2000–2007. EoE patients were defi ned by recent consensus guidelines (≥15 eosinophils in at least one high-powered fi eld; at least one typical symptom of esophageal dysfunction; other causes of esophageal eosinophilia excluded; and lack of a response to a proton-pump inhibitor). Endoscopic reports of patients with either known or suspected EoE were assessed, and patients who

Figure 1.

Figure 2.

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had esophageal photos taken under both white and blue light were included in the study. Blinded endoscopic still images were then individually reviewed by each of three physicians with expertise in esophageal disorders and EoE, and qualitatively assessed as to whether the fi ndings were more prominent with NBI or white light.Results: A total of 11 patients were included in this study, mean age was 43 years (range 22-53), 6 (55%) were men, 10 (91%) were Caucasian, and 8 (73%) were confi rmed to have EoE (4 men, 4 women). Eight patients had esophageal rings, 2 of whom had superimposed linear furrows and white plaques, 2 had furrows without rings, and 1 had an endoscopically normal esophagus. Of the 33 image sets assessed in this study, NBI was deemed supe-rior 19 times (58%) compared with 6 times (18%) for white light; white light and NBI were felt to be equivalent 8 times (24%; p=0.001; see Figure). Quali-tatively, use of NBI made the endoscopic fi ndings more prominent and readily visible; linear furrows appeared deeper and more well-defi ned, and rings stood out with greater contrast and shadowing.Conclusion: NBI highlights typical endoscopic fi ndings of EoE, including rings and furrows. Examining the esophagus under blue light may increase diagnostic sensitivity and allow targeted biopsies more effi ciently than using techniques such as chromoendoscopy. Prospective analysis of the impact of this technique is warranted.

58

Prevalence and Predictors of Lymph Nodal Metastasis in Superfi cial Esophageal Cancer: A Systematic ReviewLarissa Fujii, MD, Ananya Das, MD, Michael Crowell, MD, FACG, Virender Sharma, MD, FACG. Mayo Clinic, Phoenix, AZ.

Purpose: Lymph node metastasis is an important prognostic factor in super-fi cial esophageal cancer and is key when considering curative endoscopic therapy. Our recent work using SEER registry data showed that depth of inva-sion, size of tumor ≥20 mm, and histological grade were signifi cant predic-tors of nodal involvement (Gastroenterology 200; 136: A456). Th e objective of this study was to evaluate the overall prevalence and clinco-pathological risk factors for nodal disease in patients with T1 esophageal cancer using systematic review.Methods: A MEDLINE search of articles published from 01-1998 through 12-2008 was performed by a trained librarian. Additional hand search of MED-LINE, bibliography, and abstracts from DDW, ACG, and BSG (2004-2008) was performed. English language studies that reported the prevalence of lymph node metastasis in mucosal and submucosal esophageal cancer were identifi ed and included. Descriptive and Chi square analysis was performed.Results: A total of 37 full-length articles (23 East Asia, 7 United States, and 7 European) and 3 abstracts were included in our analysis (n=6150; 63±3 yrs; 84% male; 74% squamous histology and 26% adenocarcinoma). Lymph nodal involvement was found in 1541 patients (25%; 95% CI - 20%-30%) and was signifi cantly higher in squamous than adenocarcinoma (28.5% vs. 13.9%; p<0.0001). Th ere was a signifi cant increase in the risk of lymph node metastasis with increasing depth of invasion; m1 (intraepithelial; 0%), m2 (lamina pro-pria; 2%; 95% CI - 1%-4%), m3 (muscularis mucosa; 11%; 95% CI - 9%-14%), sm1 (superfi cial ⅓ of submucosa; 22%; 95% CI - 19%-25%), sm2 (middle ⅓ of submucosa; 33%; 95% CI - 29%-36%), through sm3 (deepest ⅓ of submucosa; 49%; 95% CI - 46%–52%; p≤0.03). Poor diff erentiation, size ≥20 mm, non-fl at endoscopic type, lymphovascular involvement (p<0.0001 for ALL analyses) and upper third location (p<0.04) were signifi cantly associated with lymph node metastasis.Conclusion: Our systematic review has identifi ed that depth of invasion, his-tological type and grade, size, location, endoscopic type, and lymphovascu-lar invasion are important determinants of lymph nodal involvement in T1 esophageal cancer. Higher lymphovascular invasion involvement in squamous cancer that predominantly eff ects upper third of the esophagus may represent socio-demographic diff erences in histological subtypes and its eff ect on access to health care. ALL the prognostic factors should be taken into consideration when deciding on curative endoscopic therapy for patients with superfi cial esophageal cancer.

59

Use of Antisecretory Medication aft er Antirefl ux Surgery for Patients with Gastroesophageal Refl ux Disease (GERD): A Systematic Review of Randomized Control Trials (RCTs)Yuhong Yuan, MD, PhD,1 Neil Dattani, BHSc,1 Carmelo Scarpignato, MD, DSc, PharmD,2 Richard Hunt, MB, AGAF1. 1. Department of Medicine, Farncombe Family Digestive Disease Research Institute, McMaster University, Hamilton, ON, Canada; 2. School of Medicine & Dentistry, University of Parma, Parma, Italy.

Purpose: Although antirefl ux surgery (ARS) is eff ective for some patients with GERD, a proportion of these patients require further antirefl ux medication (ARM) aft er a variable period. We investigated the need for further ARM aft er ARS in RCTs.Methods: MEDLINE and EMBASE databases were searched to March 2009 for published, English-language, RCTs investigating the effi cacy of ARS for GERD in adults, and reporting ARM use aft er ARS. Th e proportion of patients using ARM aft er ARS were sample size weighted and pooled applying a ran-dom-eff ects model using StatsDirect 2.7.2®.Results: In total, 18 RCTs met inclusion criteria with follow-up ranging from 1 month to 11.4 years. Th ree were follow-up reports (1–10 years) from 3 other RCTs (1 month-5 years) and 2 trials reported data for more than one time point. Th ree studies were partial randomized trials (patients ran-domized to PPIs could be converted to surgery aft er a defi ned time period). Most surgical interventions were fundoplication, 5 trials compared fun-doplication with ARM (most were PPIs), and others compared diff erent types of fundoplication (i.e. partial or total). When all trials were pooled, regardless of follow-up duration, and only considered the last measured data for the same study, 14% (95%CI 9%–20%) of patients required ARM aft er ARS (15 RCTs, n=1585) (Fig). Th e corresponding data for the use of PPIs was 11% (6%-17%, 10 RCTs, n=1027). When subgroup analyses were performed for diff erent follow-up periods, the proportions of patients who required ARM aft er ARS were 5% (0.05%-19%, 3 RCTs, n=304), 6% (3%-9%, 7 RCTs, n=849), 13% (9%-18%, 5 RCTs, n=548), and 34% (20%-48%, 5 RCTs, n=378) for 1–6 months, 1–3 years, 5–6.9 years, and 9.1–11.4 years, respectively.Conclusion: Aft er antirefl ux surgery in randomized control trials, 14% of patients still require antirefl ux medication. Th is fi gure increases with the duration of follow-up and up to 34% of patients required antirefl ux medication aft er 10 years. Some patients still suff er refl ux symptoms even aft er corrective surgical therapy which identifi es an important unmet need.

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60

Link of Gallstones and Endoscopically Suspected Esophageal Metaplasia (ESEM) in Japanese Patients: Case-control studyJuntaro Matsuzaki, MD,1 Hidekazu Suzuki, MD, PhD,1 Keiko Asakura, MD, PhD,2 Kenro Hirata, MD,1 Yoshimasa Saito, MD, PhD,1 Toru Takebayashi, MD, PhD,2 Toshifumi Hibi, MD, PhD, FACG1. 1. Division of Gastroenterology, Department of Internal Medicine, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan; 2. Department of Preventive Medicine and Public Health, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan.

Purpose: Bile and acid exposure is thought to be a major risk factor for Barrett’s esophagus in Western countries. Th e association of gallstones with Barrett’s esophagus has not been fully evaluated. Th e present study was designed as a case-control study for determining the possible factors associ-ated with endoscopically suspected esophageal metaplasia (ESEM), defi ned as an endoscopic fi nding suggestive of BE, in Japanese patients.Methods: 528 patients with ESEM were allocated to the case group, while 528 age- and gender-matched patients without ESEM were allocated to the control group. Findings on esophagogastroduodenoscopy and clinical back-ground factors were compared using multivariate logistic regression model.Results: Th e presence of gallstones (GS) and hiatus hernia (HH), and the extent of GA was independently associated with the presence of ESEM (Odds Ratio [OR] 1.67, 95% confi dence interval [CI] 1.03-2.69; OR 2.75, 95% CI 1.75-4.33; OR 1.25, 95% CI 1.01-5.6, respectively). Compared with subjects with neither gastric corpus atrophy (GCA) nor GS, although subjects with GS alone were not associated with the presence of ESEM (OR 1.59, 95% CI 0.87-2.92), sub-jects with both GCA and GS were strongly associated with the presence of ESEM (OR 2.94, 95% CI 1.40-6.17).Conclusion: Th e presence of GS and HH and the extent of GA independently associated with the presence of ESEM in the Japanese outpatient population, suggesting a causal association of distal esophageal bile acid exposure with the development of ESEM. Further studies are needed to confi rm our fi ndings in cases with histologically confi rmed Barrett’s esophagus.

61

A Prospective Study to Compare a Symptom-Based Reflux Disease Questionnaire with Bravo pH Capsule Monitoring for the Identifi cation of Gastroesophageal Refl ux DiseaseBrian Lacy, PhD, MD, FACG,1 Robert Chehade, MD,1 Michael Crowell, PhD, AGAF, FACG2. 1. Dartmouth-Hitchcock Medical Center, Lebanon, NH; 2. Mayo Clinic, Scottsdale, AZ.

Purpose: Th e accurate diagnosis of gastroesophageal refl ux (GERD) is prob-lematic. Th e GERD-Q is a validated, 6-item questionnaire developed to help identify patients with GERD. Prospective data comparing this questionnaire to Bravo pH capsule results is lacking. Th e aim of this study was to evaluate the association between GERD-Q scores and parameters of 48-hr wireless pH recording in patients (Pts) studied either on or off acid suppression.Methods: Consecutive patients referred for Bravo pH testing were eligible for inclusion. Demographics, symptoms, type, dose and frequency of acid suppres-sants were obtained. Th e GERD-Q score was calculated as the sum of heartburn, regurgitation, upper abdominal pain, nausea, diffi culty sleeping, and need for additional medication (total score 0-18). Bravo pH data and symptom association probability (SAP) were calculated for Day 1, Day 2, and total (48 hours). A per-cent pH <4.0 for more than 5.8% of the 48-hour period was considered abnormal. SAP scores >95% were considered abnormal. Endoscopic fi ndings were recorded. Multivariate logistic regression models, controlling for age, gender, and BMI, were used to evaluate the association between amplifi ed GERD-Q scores and abnormal esophageal acid refl ux and SAP scores in Pts studied on or off PPI.Results: Bravo pH-metry was completed in 204 patientss (age 51+15 yrs; BMI=28+7 kg/m2; 70% women; 95% Caucasian). Th e mean duration of symptoms was 92+104 months. Capsules were placed during EGD (55%) or transorally without sedation (45%). Th e pH study was completed while on PPI in 53% of Pts (48% q.d.; 52% b.i.d.). Premature detachment or loss of signal resulted in the exclusion of 5 studies (2.5%). Abnormal acid exposure was noted in 18/105 (17%) Pts on PPI and 49/94 (52%) Pts off PPI. Controlling for age, gender, and

BMI, the odds of an abnormal study were 5.9 (95% CI, 2.99-11.54) times greater in patients studied off PPI. Th e mean GERD-Q score was 9.3+2.8 in patients off PPI and 8.3+2.6 in Pts on PPI (p<0.01). In patients studied off PPI, the GERD-Q was associated with increased odds of an abnormal pH study (OR 1.25; 95% CI 1.04-1.49) and SAP (OR 1.22; 95% CI 1.08-1.39), but not in patients studied on PPI. More frequent use of extra medications to treat refl ux symptoms was posi-tively associated with an abnormal pH study (OR 2.21, 95% CI 1.37-3.55) and SAP (OR 1.69; 95% CI 1.02-2.80) in patients studied off PPI only.Conclusion: Higher GERD-Q scores were predictive of an abnormal pH study in patients studied off PPI. Higher scores for the use of additional medications were most likely to predict an abnormal Bravo pH capsule study. Th e test per-formed most robustly for patients studied off PPI therapy. Additional prospec-tive studies to confi rm these results are required.

62

Transatlantic Barrett’s Esophagus: Are We Divided By More Th an the ‘O’?Sean Preston, BSc (Hons), PhD, MBBS, MRCP,1 Ashley Simpson, BSc,1 Simon Leedham, PhD, MBBS, MRCP,1 Stuart McDonald, PhD,2 Adam Graham, MBBS,1 Trevor Graham, PhD2. 1. Barts and the London NHS Trust, London, United Kingdom; 2. Cancer Research UK, London, United Kingdom.

Purpose: In January 2006, the British Society of Gastroenterology (BSG) updated their guidelines on the management of Barrett’s Esophagus (BE). Th e most notable change cited in this publication was that intestinal metaplasia (IM) was no longer required within the columnar lined esophagus (CLE) to make the diagnosis of BE. Signifi cantly, this made the UK defi nition far more inclusive than American College of Gastroenterology (ACG) defi nition of BE, throwing the future of transatlantic research in to doubt. Are we in the same ballpark?Methods: A retrospective analysis of all case notes and endoscopic records of patients diagnosed with BE aft er January 2006, as per the BSG guidelines, from a single UK tertiary referral centre was carried out. Th ose with a CLE but no IM (BSG diagnosis) were compared to those with CLE and IM (ACG diagno-sis) and signifi cant diff erences in the length of CLE, the number of biopsies taken and the presence of infl ammation and hiatus hernia sought.Results: 196 patients were identifi ed, all fulfi lling the BSG diagnosis of BE; of those 76 had no detectable IM within the CLE, not diagnostic of BE by ACG criteria. Th ose patients meeting the ACG and not the BSG defi nition of BE had approxi-mately 2.5 times more biopsies taken of their CLE (MWU, p=1.7 � 10-5) than those without IM within the CLE. Interestingly, the number of biopsies taken per cm was not signifi cantly diff erent between the two groups (MWU p=0.1838); patients with IM tended to have slightly fewer biopsies per cm (1.1/cm in the IM group vs. 1.2/cm in the non-IM group). Th e CLE was on average 1cm longer (MWU, p=0.043) in patients with IM within their CLE and they were more likely to have esophagitis (Chi-squared test p=0.016). No association was found between IM and the presence or length of an hiatus hernia, indicating correct anatomical sampling. Interestingly, those with IM were, on average, 7.5 years older than those without IM (p=.003). No gender diff erence detected between the two groups.Conclusion: Oscar Wilde was wrong, the US and UK are now separated by more than a common language; the former needs IM, the latter does not. From our data, is appears that strict adherence to the Seattle biopsy protocol in the UK would increase the diagnosis of IM. Consecutive CLE biopsies taken at a younger age in the US, however, may not detect IM, resulting in discharge from the BE screening program. In CLE less than 3 cm in length we suggest a minimal of 8 are biopsies taken; size does matter. However, in the absence of a unifi ed diagnosis transatlantic research in BE is in jeopardy.

63

Bravo pH Testing: Should Patients be Tested On or Off Acid Suppressants?Brian Lacy, PhD, MD, FACG,1 Andrew Dukowicz, MD,1 Julia Weiss, MS2. 1. Dartmouth-Hitchcock Medical Center, Lebanon, NH; 2. Department of Community and Family Medicine, Hanover, NH.

Purpose: Th e decision to evaluate patients with acid refl ux symptoms on or off acid suppression is controversial. Prospective data on the use of Bravo pH capsule

© 2009 by the American College of Gastroenterology The American Journal of GASTROENTEROLOGY

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testing on or off acid suppression is lacking. Our aim was to assess the role of Bravo pH monitoring either on or off acid suppression in patients with typical refl ux or extraesophageal (chest pain, chronic cough, asthma, ENT) symptoms.Methods: Data was collected prospectively from patients referred for Bravo pH testing. Demographics, duration of symptoms, the reason for the test (heartburn, regurgitation, chest pain, chronic cough, asthma, ENT symp-toms), and the type, dose, and frequency of acid suppression were recorded at the time of Bravo pH capsule placement. Standard pH data (total number of refl ux episodes, number of episodes >5 minutes, % total time with acid refl ux, DeMeester score, symptom association probability (SAP)) was cal-culated and analyzed for Day 1, Day 2 and 48 hours (total). A study was considered abnormal if the total fraction of time with acid refl ux >5.8% or if the 48-hour DeMeester score >14.72. SAP scores >95% were considered sig-nifi cant. Patients with prior esophageal or gastric surgery were excluded.Results: 269 patients were evaluated (mean age=48 years; 65% women). 97% were Caucasian; the mean duration of symptoms was 66 months. 105 patients (39%) were evaluated for acid refl ux symptoms (heartburn or regurgitation) off acid suppression. 74% of these studies were abnormal; 26% were normal (p<.0001); 79% had an abnormal SAP for refl ux symptoms. 95 patients (35%) were evaluated for refl ux symptoms on acid suppression; 25% had an abnormal study, while 75% were normal (p<.0001). 69 patients (26%) were evaluated for extraesophageal symptoms; 42% had an abnormal study. 66% were abnormal off acid suppression while 21% were abnormal on a daily PPI and 6% were abnormal on a twice daily PPI (p<.0001). Patients with chest pain (n=35) and chronic cough (n=23) were more likely to have a normal study on PPI therapy than off (p<.0002 for chest pain; p< .02 for chronic cough). Abnormal SAP scores were infrequent in the extraesophageal group—24% off meds, 7% on a q.d. PPI, and 6% on a b.i.d. PPI.Conclusion: Th is prospective Bravo pH capsule study demonstrates that acid refl ux is uncommon in patients with extraesophageal symptoms on PPI therapy. Th ese patients should be evaluated off acid suppression to objectively assess the relationship between symptoms and acid refl ux. Th e majority of patients (75%) with refl ux symptoms tested on acid suppression had a normal study with a normal SAP indicating that symptoms were not associated with acid refl ux. Patients with a low pretest probability of having acid refl ux should be tested off PPI therapy.

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Covered Esophageal Stent for the Treatment of Iatrogenic Esophageal PerforationAnand Raman Kumar, MD, MPH, Julian Perez, MD, Dan Sher, MD. Medicine/Gastroenterology, Albert Einstein Medical Center, Philadelphia, PA.

Purpose: Esophageal perforation is a life-threatening complication of esophageal dilation. We describe a case of esophageal perforation following dilation of a refrac-tory benign refl ux stricture that was treated conservatively with a covered stent. Case Presentation: A 62 year old African American male nursing home resident presented to the emergency department with episodes of melena and hypotension around 6 days aft er his last esophageal dilation. He had a severe refractory lower esophageal sphincter (LES) refl ux stricture failing bougie and balloon dilation on several occasions, with multiple episodes of food impaction. His past medical his-tory was signifi cant for 50 pack-years of smoking, ethanol abuse, Barrett’s mucosa without dysplasia, end-stage renal disease on hemodialysis and coronary stents. He was uncooperative and no further history could be obtained. Hospital Course and Follow-up: Th e patient was admitted to the intensive care unit. His hemoglobin had dropped from a baseline of 12 to 6 gm/dl requiring transfusion. His initial chest x-ray was unremarkable. Subsequent nasogastric lavage demonstrated bright red blood that did not clear. Upper endoscopy revealed copious fresh blood in the esophagus and stomach, ulceration at the stricture site and a defect in the distal esophagus at 38 cm. Subsequently, it was decided to place a non-metal covered (Polyfl ex®) 9 mm stent in the esophagus under fl uoroscopic guidance and antibiotic treatment was initiated. A second look endoscopy and an esophagogram confi rmed the position and patency of the stent and showed no evidence of leak. Th ough the patient recovered without any further events, he was evaluated for eventual esophageal resection secondary to the refractory nature of the refl ux stricture and perforation.

Conclusion: Th is case highlights two signifi cant complications of esophageal dilations for strictures - perforation and bleeding. Occlusive esophageal stents provide a non-surgical, safe and eff ective way of treating patients with an iatrogenic esophageal perforation. Early recognition of perforation and sub-sequent stent placement has been found to improve the rates of perforation closure and tolerance of oral diet. Th e placement of these stents also avoids the morbidity associated with thoracotomy and/or laparotomy in an already sick patient.

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Does Bile Have a Role in the Development of Barrett’s Esophagus and Consequently the Increasing Incidence of Esophageal Adenocarcinoma?Mukhtar Al-Saadi, MD. Internal Medicine, Detroit Medical Center, Detroit, MI.

Purpose: Th e incidence of esophageal adenocarcinoma (EAC) is increasing considerably. In the United States, the rate of increase in EAC in the last 30 year is greater than that of any other major malignancy. Our aim is to identify evi-dence evaluating an association between exposure of the esophageal mucosa to bile and development of EAC.Methods: A medline search was performed to identify all pertinent English language reports of GERD, duodenogastroesophageal refl ux (DGER), Barrett’s esophagus (BE), and EAC until December of 2008.Results: Th e rising incidence of EAC represents a real increase of disease bur-den. BE is considered the only confi rmed risk factor of EAC and caused by chronic GERD. GERD symptoms can be relieved in about 80-90% of cases with acid suppression therapy (AST); however, no decrease in the incidence of EAC has been documented. Th ere is a concern that partial gastric acid sup-pression into PH ranges of 3-6 by AST encourages the formation of non polar-ized, soluble bile acids, which can penetrate and injure esophageal mucosa. AST does not suppress DGER and direct measurement of esophageal bilirubin exposure as a marker for DGER has shown that about half of patients with GERD have increased esophageal exposure to duodenal secretions. Animal studies have shown that bile refl ux into the esophagus increases the preva-lence of BE and EAC. Experimental studies showed that combined bile and gastric acid can induce genes involved in diff erentiation, signal transduction and carcinogenesis of the esophageal epithelium and up regulate oncogenes implicated in BE and EAC. Acid and DGER was the predominant refl ux pat-tern in 95% of patients with BE.Conclusion: Combined bile and gastric acid refl ux could result in more severe esophageal mucosal injury manifested as BE and EAC. Incomplete acid sup-pression with AST may predispose to the development of BE and consequently EAC. Th is theory may explain the increasing incidence of EAC that has been observed concomitantly with the increasing use of AST.

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Comparison of Standard, Large Capacity, and Jumbo Forceps for Sampling of Barrett’s Esophagus: Results of a Randomized TrialSusana Gonzalez, MD,1 Woojin Yu, MD,1 Michael Smith, MD, MBA,2 Heidrun Rotterdam, MD,1 Kristen Slack, BS,1 Julian Abrams, MD, MS,1 Charles Lightdale, MD, FACG1. 1. New York Presbyterian Hospital-Columbia University Medical Center, New York, NY; 2. Temple University Hospital, Philadelphia, PA.

Purpose: For Barrett’s esophagus (BE) surveillance, the Seattle protocol rec-ommends the use of jumbo forceps, which require the use of a therapeutic upper endoscope, although ACG guidelines do not specify forceps size for BE surveillance. Th ere are newer forceps, with larger outer diameters than previ-ous standard forceps that can be used with standard-sized endoscopes. It is unclear whether there are diff erences with regard to quality of sampling using standard forceps, newer large capacity forceps, and jumbo forceps.Methods: From May to October 2008, patients with BE undergoing surveil-lance endoscopy were randomly assigned to have biopsies taken with 1 of 3 biopsy forceps (Boston Scientifi c, Natick, MA): Radial Jaw 3 (RJ3; 2.2mm outer diameter (OD)); Radial Jaw 4 Large Capacity (RJ4; 2.4 mm OD); and Radial Jaw 4 Jumbo (Jumbo; 2.8 mm OD). Random four quadrant biopsies

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were taken for every 1-2 cm of BE. Specimens were reviewed by two expert GI pathologists, who were blinded to the forceps used. We recorded number of gross pieces, maximum diameter, tissue layers included, specimen orientation, and adequacy. Th e a priori defi nition of an adequate biopsy was a well-oriented specimen ≥2 mm in diameter with muscularis mucosa present.Results: Sixty-fi ve patients underwent upper endoscopy with surveillance biopsies: 21 (32%) with RJ3, 21 (32%) with RJ4, and 23 (35%) with jumbo. Th e mean age was 68, and 72% of patients were male. Th e mean BE length was 1.7 cm, and 54% of patients had received prior treatment for BE. Mean biopsy diameter was 3.12 mm for jumbo, 2.76 mm for RJ4, and 2.69 mm for RJ3 (Jumbo vs. RJ4, p=0.0002; jumbo vs. RJ3, p<0.0001). Th ere was no signifi cant diff erence in the proportion of pieces ≥2 mm across the three groups. However, a signifi cantly higher proportion of biopsies using RJ4 compared to jumbo forceps was well-oriented (44.2% vs. 35.2%, p=0.03), contained muscularis mucosa, (56.7% vs. 44.1%, p=0.004), and were considered adequate (37.8% vs. 25.2%, p=0.002). Th ere were no signifi cant diff erences between the three forceps with regard to detection of dysplasia (p=0.97) or intestinal metaplasia (p=0.46). Th ere were no complications due to biopsies in any of the subjects.Conclusion: In our randomized trial, jumbo forceps obtained larger biopsies, but large capacity forceps were superior with respect to specimen orientation, depth of biopsy, and overall specimen adequacy for pathological interpreta-tion. We did not fi nd diff erences in dysplasia detection rates, although our study was not specifi cally designed to answer this question. Large capacity RJ4 forceps produced optimal biopsies in BE surveillance and did not require the use of a therapeutic endoscope.Th is research was supported by an industry grant from Boston Scientifi c.

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Clinical Characteristics of Patients Who Fail Radiofrequency Ablation for Barrett’s EsophagusHaleh Pazwash, MD, Dana Inzeo, APRN, Arthur Antler, MD, MD, FACG, Vivian Bethala, MD, MD, Anthony Delillo, MD, Babak Firoozi, MD, Donald Kutner, DO, Robert Pittman, MD, Michael Rahmin, MD, Mitchell Rubinoff , MD, FACG, Robert Korst, MD, Valley Hospital, Ridgewood, NJ.

Purpose: Although radiofrequency ablation (RFA) is successful in eradicating intestinal metaplasia in the majority of cases, in a distinct minority of patients, this modality is unsuccessful in achieving this goal. We sought to describe the clinical characteristics of a cohort of patients who failed RFA treatment.Methods: A Barrett Esophagus Center was established at a single institution which accrued 59 patients over a two year period (May 2007-May 2009) under the auspices of an IRB approved protocol. In total, 81 RFA treatments were performed in 37 patients with Barrett’s Esophagus (BE) using the BARRX device. Pre-treatment histology included no dysplasia, indefi nite for dyspla-sia, low grade as well as high grade dysplasia. Failure of RFA was defi ned as either healing with a recurrent columnar lining, or persistent ulceration pres-ent more than two months following RFA, despite doubling of the dose of the proton pump inhibitor (ppi). Data collected included patient age and gender, size of hiatal hernia, length of Barretts segment, the histologic characteriza-tion of BE, the historical duration of refl ux symptoms, and the presence or absence of persistent refl ux symptoms while taking proton pump inhibitors.Results: Of 37 patients undergoing RFA, six met the defi nition for failure. 5 patients were male and 1 patient was female. Mean age was 59 years (47-72). Th e average duration of heartburn symptoms experienced by these patients was 7 years (2-20 years). 5 of these patients experienced symptoms of heart-burn despite being on double-dose daily ppi therapy. Histologically, 4 had no dysplasia, 1 was indefi nite for dysplasia, and one was a low grade dysplasia which progressed to high grade during the duration of the study. Th e mean hiatal hernia size was large 5.8 cm (3-8 cm). Th e mean length of the BE was long 9 cm (7-11 cm). 3 of the 6 patients subsequently opted to have surgical fundoplication post-RFA treatment.Conclusion: A subset of patients did not show eradication of Barrett’s using RFA and required surgical fundoplication. Long segment BE and/or presence of a large hiatal hernia could be predictors of treatment outcomes. Longer and larger stud-ies will be needed for further evaluation.

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Esophageal Squamous Papillomas and Infl ammatory Squamous Polyps: A Comparative Clinicopathologic StudyJonathan Glickman, MD, PhD. Caris Diagnostics, Newton, MA.

Purpose: Th e pathogenesis of esophageal squamous papillomas (ESP) is uncertain. While some studies have suggested that they are the result of human papilloma virus infection, other investigators consider them a reac-tive hyperplasia in response to esophagitis. Infl ammatory squamous polyps (ISP) are another benign esophageal polyp that is not well described but is thought to arise in the setting of gastroesophageal refl ux disease (GERD). Some investigators have proposed that this lesion is a histologic subtype of ESP. Th e objective of this study was to compare the clinicopathologic features of these two lesions.Methods: Th e case database of a large national pathology laboratory was searched for examples of ESP and ISP during the period March 2007 to March 2008. Clinical (age, gender, symptoms, endoscopic fi ndings) and pathologic features (location, morphologic growth pattern, associated esophagitis and Barrett’s mucosa) were collected and compared between the two groups.Results: A total of 278 patients with ISPs and 90 with ESPs were identifi ed (out of 40214 patients who had esophageal biopsies); three patients had both types of lesions. Compared to ESPs, ISPs were more likely to occur in male patients (M/F ratio 1.5:1 vs. 0.55:1, p<0.001) and to be associated with a clinical history or symptoms of GERD (70 vs. 49%, p=0.004). ISPs were located predominantly in the lower third and GEJ region (73%), whereas ESPs were most frequently in the middle and upper third of the esophagus (65%) (p<0.001). ISPs and ESPs were histologically distinct, with the latter comprised of thickened endophytic squamous epithelium associated with infl ammation, and the former consisting of exophytic squamous epithelium with fi brovascular stalks.Conclusion: Esophageal squamous papillomas and infl ammatory squamous polyps are histologically distinct benign lesions that occur in overlapping but diff erent clinical settings. Th ese fi ndings support the hypothesis that they most likely diff er in their pathogenesis.

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Endoscopy vs. Standard Manometry vs. High Resolution Esophageal Pres-sure Topography (HREPT) for Detection of Hiatal HerniaSyed Hashmi, MD, Konrad Schulze, MD, Robert Summers, MD, Satish Rao, MD, PhD, FACG. Internal Medicine, University of Iowa Hospitals and Clinics, Iowa City, IA.

Purpose: Gastroenterologists routinely diagnose hiatal hernia with an upper endoscopy (EGD). However, the diagnostic yield of endoscopy for the detection of hiatal hernia when compared to manometry has been scarcely assessed. HREPT provides information on esophageal manometry, topogra-phy and bolus transport in the supine and upright positions. Hypothesis: HREPT is more accurate than EGD for the detection of hiatal hernia. Aim: To examine the diagnostic yield of EGD, supine esophageal manometry and HREPT in the standing upright position for the detection of hiatal hernia and to examine changes in esophageal function.Methods: 50 patients (m/f= 24/26; mean age 49 yr) with GERD and/or dyspha-gia underwent both EGD and HREPT. Endoscopist reported the presence and length of hiatal hernia. HREPT was performed by placing a 36 sensor (Sierra Scientifi c) probe, 1 cm apart from the pharynx to stomach, and the manometric/topographic changes were examined in supine (standard) and upright positions. A hiatal hernia was identifi ed on HREPT as two separate bands of HPZ, at least 1cm apart. Also LES pressure, length and HPZ length were assessed.Results: (Table, mean+SEM Bold=p<0.05): EGD detected signifi cantly fewer (p=0.0001) subjects with hiatal hernia when compared to HREPT, but its yield was similar to standard supine manometry (see Table). HREPT in the standing position detected twice as many subjects (p=0.0001) with a hiatal hernia when compared to standard supine manometry (see Table). Th e length of hiatal

© 2009 by the American College of Gastroenterology The American Journal of GASTROENTEROLOGY

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hernia was signifi cantly longer (p=0.0001) with HREPT in the standing posi-tion when compared to EGD. LES pressure was higher (p=0.0001), mean length was longer (p=0.0003), and length of HPZ was longer (p=0.0001) in upright than supine position.Conclusion: HREPT when performed in the standing position is superior to endoscopy or supine manometry for the detection of hiatal hernia, and should be the preferred approach for identifying hiatal hernia in subjects with GERD. Esophageal function and manometric parameters are signifi cantly aff ected by body position.

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Utility of Endoscopic Ultrasound to Determine the Depth of Cryospray Ablation Th erapy of Dysplastic Barrett EsophagusJayaprakash Sreenarasimhaiah, MD, Shailender Singh, MD, Luis Lara, MD. Medicine/Gastroenterology, University of Texas Southwestern Medical Center, Dallas, TX.

Purpose: Barrett esophagus has been shown by histology to be confi ned to the mucosa. Dysplasia, however, may aff ect deeper layers with more advanced his-tology. Cryospray ablation has now become established as a mininally-invasive therapy for treatment of dysplastic Barrett tissue with low morbidity and favor-able clinical outcomes. While post-therapy studies examining histology have been performed, there is only limited data regarding the depth of esophageal wall involvement by cryospray ablation. Th us, the objective of this study is to determine the depth of cryospray therapy on the esophageal wall using mini-mally invasive tools such as endoscopic ultrasound (EUS) to confi rm complete mucosal ablation.Methods: Th e database for all patients who had undergone therapy for dys-plastic Barrett esophagus in the past 12 months was examined. Th is included 7 patients (6 male, 1 female, mean age of 69.4 years) in whom pre-treatment and post-treatment EUS exams were available for comparison. EUS was per-formed with a radial echoendoscope (Olympus GIF-UE160) prior to the fi rst therapy and at 8 weeks aft er the fi nal ablation session. Th e thickness of the mucosa, submucosa, and total esophageal wall were recorded. Cryospray abla-tion was performed with liquid nitrogen using a spray catheter per standard treatment protocol (CSA Medical, Baltimore, MD, USA). Patients were fol-lowed at 8 week intervals on twice daily dose of esomeprazole and treated again for residual Barrett mucosa. Four-quadrant biopsies were taken at 1 cm intervals aft er the treatment was completed at 8 weeks to determine ablation success.Results: Increased esophageal full wall thickness was noted in all patients after therapy. The muscularis propria (4th esophageal layer) appeared endosonographically to be intact with well-defined borders but developed increased thickness. Both the mucosa and submucosa increased in thick-ness as well from baseline. In one patient, successful endoscopic mucosal resection (EMR) of a dysplastic nodule was performed following cryother-apy. In all patients, eradication of dysplasia was achieved. EUS revealed no celiac or peri-esophageal lymph nodes either before or after therapy. See Table.Conclusion: EUS imaging demonstrates the depth of cryospray therapy to involve both the mucosa and submucosa. Th e total thickness of the esophagus wall increased with therapy. However, the muscularis propria appeared intact which suggests that successful EMR can be performed following cryospray ablation. Th e EUS fi ndings may represent deep tissue ablation but may also depict scarring and fi brosis and thus needs to be validated with studies of full-thickness esophageal histology.

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Hybrid Th erapy with EMR and RFA Th roughout Treatment Sessions for Barrett’s NeoplasiaVani Konda, MD, Jennifer Chennat, MD, John Hart, MD, Amy Noff singer, MD, Frank Caira, BS, Mark Ferguson, MD, Mitchell Posner, MD, Irving Waxman, MD. University of Chicago Medical Center, Chicago, IL.

Purpose: Patients with high grade dysplasia (HGD) and intramucosal carci-noma (IMC) in the setting of Barrett’s esophagus (BE) may undergo a combi-nation of modalities to achieve total Barrett’s eradication (TBE). Initial EMR of any visible lesions followed by a radiofrequency ablation (RFA) in repeated sessions is emerging as a method to achieve TBE. Our aim is to report our initial experience with a combined approach of EMR and RFA to treat both initial and follow up lesions in the management of HGD and IMC in BE.Methods: Patients referred to our institution for the treatment of BE with HGD and IMC were enrolled in a protocol for treating long segment BE with EMR of any suspicious abnormalities in initial or follow up visits and ablation of remaining epithelium with RFA. Detailed white light exams and exams with narrow band imaging and acetic acid were performed to look for suspicious abnormalities. Follow-up sessions were performed at 3-6 month intervals.Results: Sixteen patients entered the hybrid protocol between February 2007 and May 2009 (mean age 66.9 y; 3 F: 13 M). Th e average length of BE was 7.8 cm. Ten patients had visible lesions. Two patients were referred with a biopsy diagnosis of IMC, and the rest had HGD. A total of 61 treatment sessions were performed with 40 EMR sessions, 20 circumferential RFA sessions, and 21 focal RFA appli-cations. 16 sessions employed a combination of EMR and RFA. An average of 7 EMRs were performed per patient with total of 111 EMR specimens. Th e 2 patients with IMC had only HGD on their fi rst EMR, whereas 3 patients with a pretreatment diagnosis of HGD were upstaged to IMC aft er initial EMR. Th irty-fi ve EMR sessions were performed aft er an RFA session to diagnose and treat the residual BE, and 16 of these yielded pathology of HGD. Eradication of dysplasia has been achieved in 4 patients, 3 of whom also have eradication of BE. Th e remaining patients were still undergoing treatment sessions. Six patients have experience esophageal stenoses, managed with endoscopic dilations (median 1.5). One patient required multiple dilations and steroid injection.Conclusion: Th e accurate histopathologic diagnosis and deliberate treatment of neoplasia in BE may require a combination of EMR and RFA not only at the initial sessions, but also in the treatment of follow-up sessions. Th e most eff ec-tive way to manage residual areas of neoplasia needs to be addressed.

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Spectral-Domain Endoscopic Optical Coherence Tomography (EOCT) Using a Balloon Probe for Esophageal ImagingGerard Isenberg, MD, MBA, Wei Kang, PhD, Hui Wang, PhD, Yinsheng Pan, PhD, Michael Jenkins, PhD, Amitabh Chak, MD, Deepak Agrawal, MD, Andrew Rollins, PhD. Medicine, Case Western Reserve University, Cleveland, OH.

Purpose: EOCT obtains micron-scale, cross-sectional structural images to depths exceeding 1 mm in the esophagus. Th e 1st generation EOCT systems

Mean LES length cm

LES basal Pr mm Hg

HPZ length cm

H. hernia length cm

H. hernia detected

H. hernia not detected

Upright HREPT

2.9 ± 0.12 39.3 ± 1.5 4.7 ± 0.28 3.3 ± 0.33 39 11

Supine Manometry

2.5 ± 0.13 23.2 ± 1.7 1.1 ± 0.15 0.6 ± 0.15 18 32

EGD 1.5 ± 0.43 17 33

Patient Age

Pre-TX MU + SM

(mm)

Post-TX MU + SM

(mm)

Pre-TX FT

(mm)

Post-TX FT (mm)

% Change in MU + SM

% Change in FT

A 62 4.9 7.2 8.6 9.1 46 6

B 71 1.7 4.2 2.5 6.0 147 140

C 77 2.4 3.5 2.9 6.0 46 107

D 71 2.2 3.8 3.1 4.8 73 55

E 61 1.0 1.4 1.3 4.0 40 208

F 76 1.8 4.0 4.1 6.8 122 66

G 68 2.1 2.5 2.4 4.4 19 83.3

AVG 69.4 2.3 3.8 3.6 5.9 70.4 95

Mu=mucosa; SM=Submucosa; FT=Full thickness; *EMR.

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employed a time-domain OCT (TD-OCT) confi guration with fi ber-optic catheter probes that could be inserted through standard endoscopes. However, the low imaging speed of TD-OCT was an obstacle for 3D visualization of long segments. Also, these probes were designed for spot examination of focal lesions. Th is is not suitable for surveillance of Barrett’s esophagus (BE) where the area of mucosa would be 20 sq cm or more. 1st generation EOCT only cov-ers a few millimeters, which is similar to the normal hit-and-miss biopsy. With the advent of Fourier-domain OCT (FD-OCT) technology, imaging speeds increased 10-fold allowing rapid in-vivo imaging. We demonstrate here the 1st ballon-based high-speed SD-EOCT system for comprehensively imaging the esophagus in vivo with the potential for surveillance of long-segment BE within minutes.Methods: Th e balloon SD-OCT system employs a 12.5 mW, broadband light source with a full width at half maximum bandwidth of 60 nm centered at 1310 nm. Th e spectral interference fringes were detected by a custom-designed, linear-k spectrometer. Th e proximal end of the catheter consisted of a fi ber rotary joint, which was driven at speeds approaching 570 rpm. A urethane low durometer balloon with a diameter of 18 mm and length of 25 mm was bound to the distal end of the catheter. During the scanning, the fi ber probe was driven by the rotary joint to circumferentially scan the whole lumen of esophagus. Simul-taneously, the pull-back system pulled the catheter longitudinally so that the probe scanned along a helical path to obtain 3D comprehensive images of the esophagus. Th e image acquisition and display was coordinated by a soft ware program written in C++. Th e system was tested in anesthetized live swine as approved by the Case Animal Lab IRB.Results: A total of 10 swine were utilized for the study with successful OCT imaging in all animals. Th ere were no equipment failures. Th ere were no com-plications. Diff erent layers could clearly be identifi ed, including the squamous epithelium, lamina propria, muscularis mucosa, submucosa and muscularis propria. 3-D imaging was possible in all 10 swine. Th e images were displayed in real-time and the entire OCT examination of the esopagus took an average of 2.7 minutes. Th e SD-EOCT balloon system proved to be both feasible and safe.Conclusion: We report here a specially designed SD-EOCT balloon system that is capable of comprehensive imaging of long segments of the esophagus, and thus can be used for real-time, in-vivo, high-speed EOCT imaging for sur-veillance of BE.

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ABSTRACT WITHDRAWN

74

Endoscopic Ultrasound (EUS) Guided Fiducial Marker Placement in Esophageal and Rectal Cancer for Radiation Treatment PlanningShivakumar Vignesh, MD,1 James Barthel, MD, FACG,1 Jason Klapman, MD,1 James Lin, MD,1 Matthew Biagioli, MD,2 Sarah Hoff e, MD2 . 1. Gastrointestinal Oncology, Moffi tt Cancer Center, Tampa, FL; 2. Moffi tt Cancer Center, Department of Radiation Oncology, Tampa, FL.

Purpose: Describe the feasibility, positional and temporal stability, safety, and utility of fi ducial markers placed with EUS, in delineation of tumor extent for radiation treatment planning in locally advanced esophageal and rectal can-cer.Methods: Patients with locally advanced esophageal and rectal cancer seen on EUS were referred for fi ducial placement with EUS. Fiducial placement was performed to demarcate the proximal and/or distal extent of tumor. Patients underwent linear EUS by 1 of 3 endoscopists. Gold cylindrical fi ducials (0.75 mm�10 mm; VISICOIL™) were back loaded into a 19 g EUS needle and sealed with bone wax. Upon EUS guided needle insertion into the target, the

fi ducial was deployed by advancing the stylet. Fiducial placement was con-fi rmed by EUS in all patients and additionally with fl uoroscopy in 7 patients. A prophylactic antibiotic was administered to all patients. A chart review was conducted to collect data including demographics, cancer stage, follow-up imaging and complications. Th is study was approved by our IRB.Results: 20 patients (18 men and 2 women), with a mean age of 70 years (range 54-92 years), underwent EUS guided fi ducial placement. 12 patients with locally advanced esophageal adenocarcinoma (staged: T3N1M0 in 5, T3N1M1a in 1, and T1N1M0 in 5 patients) and 8 patients with locally advanced rectal adenocarcinoma (staged: T3N0M0 in 5, T2N1M0 in 2, and T3N1M0 in 1 patient) underwent EUS fi ducial placement. 7 of 12 patients with esophageal cancer and 2 of 8 patients with rectal cancer had recurrent disease as the indication for fi ducial placement. A total of 39 fi ducials were placed in 20 patients; 1-3 fi ducials (mean=2) were placed in each patient. Locations of fi ducial placement included celiac node (1), rectal wall (8) and esophageal wall (11). Th e mean duration of follow-up was 11 months (range 2 to 19 months). EUS guided fi ducial placement was successful in 20/20 patients (100%) as con-fi rmed by EUS and/ or fl uoroscopy. Fiducial placement was verifi ed on treat-ment CT scans and incorporated into radiation planning in all cases. Migration of the fi ducial from site of initial placement was noted in 1 patient with rectal cancer of 20 patients (1 of 39 markers placed; 2.5%) but did not result in com-plications or aff ect treatment planning. No patient experienced complications at the end of the follow-up period.Conclusion: EUS guided fi ducial placement for locally advanced esophageal and rectal cancer is safe, precise and useful in defi ning tumor extent for radia-tion treatment planning. Migration of fi ducial markers placed with EUS guid-ance may occur rarely.

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Initial Experience with Combined High Resolution/Impedance ManometryKenneth DeVault, MD,1 Dawn Francis, MD, MPH,2 Ernest Bouras, MD,1 Mark Stark, MD,1 Sami Achem, MD1. 1. Gastroenterology, Mayo Clinic, Jacksonville, FL; 2. Mayo Clinic, Rochester, MN.

Purpose: Esophageal testing has been in a state of evolution over the past sev-eral years with two new, competing technologies attempting to better defi ne motility disorders (high resolution and impedance testing). Th ere are now sys-tems that provide both of these technologies in a single catheter/system. We sought to report our initial results with such a system.Methods: 20 consecutive patients referred to our laboratory for esophageal motility testing are the subject of this preliminary report. Each patient under-went a combined impedance/motility study, which was subsequently read and reported by one of the physician authors. A single reviewer (KD) pulled the clinical reports from the electronic medical record and recorded the indica-tion, clinical diagnosis, distal esophageal peristaltic pressure and proportion of swallows classifi ed as peristaltic, simultaneous, nontransmitted and trans-mitted but ineff ective. Th e studies were then re-analyzed using the Sandhill BioView program. Impedance data included percentage complete bolus transit and bolus transit time. Th e program also reclassifi ed swallows into peristaltic, simultaneous, nontransmitted and retrograde based on manometry pattern. Finally, the high-resolution tracing were used to re-examine any study with <80% normal contractions by any of the three methods (clinical MD review, impedance, computerized analysis).Results: The indications for the procedure were reflux evaluation (55%), dysphagia (30%), chest pain (15%). 11 studies (55%) were normal by all three methods. The results for the 9 patients who were abnormal by at least one method are in the table. High resolution testing confirmed the clini-cal interpretation in 4 patients (pt #2,6,7,8), suggested better peristalsis in 4 (pt #3,4,5,9) and worse peristalsis in 1 (pt #1). Impedance testing on the other hand tended to be normal in some patients with a clear mano-metric diagnosis (achalasia in patient #8 and a severe IEM in patient #7), although we subsequently discovered that many studies were being done in 30-45 degree upright position, which may have interfered with imped-ance testing.

© 2009 by the American College of Gastroenterology The American Journal of GASTROENTEROLOGY

Abstracts S31

Conclusion: High resolution adds to the understanding of esophageal func-tion in a signifi cant proportion of patients undergoing motility testing most commonly suggesting better esophageal function. In this study, impedance seemed less eff ective. We believe that patient position may have contributed to the failure of impedance and continue to examine and refi ne our tech-nique.

76

Enhanced Salivary Protection in Patients with Negative Endoscopically Refl ux Disease Could be a Factor Contributing to Prevention of the Esoph-ageal Mucosal Injury and Complications

2009 ACG/AstraZeneca Senior Fellow AwardMarek Majewski, MD, PhD,2 Grzegorz Wallner, MD, PhD,2 Richard McCallum, MD, FACG,3 Jerzy Sarosiek, MD, PhD, FACG1. 1. Kansas University Medical Center, Kansas City, KS; 2. Medical University of Lublin, Lublin, Poland; 3. TTU HSC Paul L Foster School of Medicine, El Paso, TX.

Purpose: Gastroesophageal refl ux disease represents a spectrum of clinical manifestation from negative endoscopically refl ux disease (NERD) to Barrett’ esophagus (BE). Although the mean value of the esophageal acid exposure time is greater in BE than NERD population, the individual values in both groups overlap greatly. As the esophageal mucosal integrity depends upon the balance between aggressive factors and protective mechanisms (Majewski M. et al. Clin. Gastroenterol. & Hepatol. 5:430-8, 2007), exploration of the rate of salivary mucin secretion, the major protective factor in saliva, may help to bet-ter understand the pathophysiology of these disorders. Th erefore, the aim of the study was to explore the diff erence in the rate of salivary mucin secretion between patients with NERD and BE.Methods: Th e study was conducted in 10 patients (4F, mean age of 40) with NERD with a positive 24h esophageal pH monitoring test and 16 patients (3F, mean age of 47) with long segment (over 3cm) of BE. Salivary secretions were collected under basal conditions, during mastication and during intra-esophageal mechanical (tubing with soft infl ated balloons) and chemical [saline, HCl/pepsin (pH 2.1) and fi nal saline solution] mimicking the natu-ral gastroesophageal refl ux scenario. Th e mucin in salivary secretions was measured using periodic acid-Schiff (PAS) methodology. Statistical analysis was performed during Σ-Stat (Systat Inc. CA).Results: Th e rate of salivary mucin secretion in patients with GERD during mastication was 95% higher (P<0.05) than in patients with BE, 120% higher (P<0.01) during intraesophageal mechanical stimulation, 161% higher (P<0.01) during intraesophageal exposure to acid and pepsin solution (pH 2.1) and 269% higher (P<0.001)during the fi nal infusion of saline at the end of the experimental procedure.Conclusion: 1) The profoundly higher rate of salivary mucin secretion in patients with NERD versus subjects with BE, especially during the esopha-geal mucosal exposure to HCl/pepsin, mimicking the natural gastroesoph-

ageal reflux scenario may indicate that their protective mechanisms are in place to prevent mucosal injury. 2) Significantly lower salivary protective response in terms of mucin secretion in patients with long segment of BE may at least partly explain their susceptibility to the loss of mucosal integ-rity.

77

Implication of Intragastric pH Monitoring During pH/Impedance Study in Refractory GERD Patients on Twice Daily Proton Pump InhibitorsGuoxiang Shi, MD, PhD, Ann Ouyang, MD, FACG, Taipng Lee, MD. Penn State S. Hershey Medical Center, Hershey, PA.

Purpose: Th e mechanism of refractoriness to PPI in GERD patients remains unknown, but may be multifactorial. Could a lack of adequate inhibition of gastric acid be involved? Twenty-four hour pH/impedance monitoring is widely used to evaluate GERD patients refractory to PPIs. An intragastirc pH sensor is incorporated in some systems, but the implication of intragastric pH measurement during pH/impedance study is unclear. Th e aim of this study was to determine the pattern of intragastric pH measured during pH/impedance study and the association of intragastric pH with esophageal acid refl ux and symptom index in PPI refractory GERD patients.Methods: pH/impedance studies (Sandhill system) from 12/2006 until 5/2009 were retrospectively reviewed. Studies done while the patients were on twice daily doses of PPI were included. Th e percent time with intragastric pH <4, the percent time of esophageal acid refl ux, the total number of refl ux episodes and the symptoms index of predominant symptoms were analyzed.Results: Th ree hundred and ten pH/impedance studies were performed of which 145 (18-79 yrs, 42 men) were on twice daily doses of PPIs. Th e distribu-tion of the percent time with gastric pH<4 (PTgpH<4) is shown in the Figure. Th e median percent time was 41.2% (interquartile range 16.8-66.4%). Th ere was no diff erence in PTgpH<4 between patients on diff erent PPIs. Th ere was a negative correlation between age and PTgpH<4 (r=–0.2, p<0.05). Twenty-nine (20%) patients had >75% time with gastric pH <4 (poor acid control, PAC) and 48 (33%) had <25% of time with gastric pH <4 (good acid control, GAC). Th e esophageal acid exposure was signifi cantly greater in PAC patients than GAC patients (4.1±5.1 vs. 0.7±1.5, p=0.002) while the total number of refl ux episodes detected by impedance (acid plus non-acid) was not signifi -cantly diff erent between two groups (67.9±36.3 vs. 59.7±35.2 (normal <48), p=0.3). Th e proportion of patients with positive symptom index (i.e >50%) was not signifi cantly diff erent between PAC and GAC patients (33% vs. 20%, p>0.05).Conclusion: Th e duration of an intragastric pH<4 is highly variable in GERD patients refractory to twice daily doses of PPIs. Th e mechanism of this variabil-ity is unclear. Further evaluation of the effi cacy of PPIs regarding the timing of medication and drug interaction will be essential.

[75]

Pt# Indication % Transit (impedance) Computer interpretation Initial MD interpretation Interpretation with high resolution

1 GERD 100 % 10 % NT 30 % NT 70 % NT

2 GERD 100 % 20 % NT 30 % Retro 30 % NT 30 % NT

3 GERD 100 % 10 % Retro 20 % Ineff 30 % NT 10 % NT

4 GERD 90 % 20 % Sim 70 % NT 10 % Retro

10 % Ineff 60 % Sim 20 % NT

5 GERD 100 % 20 % Retro 70 % Ineff 100 % NL

6 Dysphagia 100 % 100 % NL 40 % NT 30 % Sim 40 % NT 30 % Sim

7 Dysphagia 100 % 10 % Sim 40 % Retro 40 % Ineff 50 % NT 40 % Ineff 50 % NT

8 Dysphagia 100 % 30 % NT 70 % Retro 100 % Sim 100 % Sim

9 Chest Pain 100 % 20 % NT 30 % Retro 20 % Ineff 30 % NT 30 % NT

NT=nontransmitted, Retro=retrograde, Sim=Simultaneous, NL=normal, Ineff=ineffective.

The American Journal of GASTROENTEROLOGY VOLUME 104 | SUPPLEMENT 3 | OCTOBER 2009 www.amjgastro.com

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78

Gender Diff erences in Esophageal Sensation Induced by Barostat Distention in Normal SubjectsMargaret Freede, RN, MS, JD,1 Philip Miner, MD, FACG,1 Howard Proskin, Statistician,2 Sattar Zubaidi, GI Lab1. 1. OFDR, Oklahoma City, OK; 2. Howard M. Proskin and Associates, Rochester, NY.

Purpose: To compare gender diff erences among normal subjects to fi rst sen-sation, fi rst discomfort, and maximum tolerable sensation induced by Baro-stat balloon distention in both the proximal esophagus and distal esophagus. Th e role of gender in manifestation of FGID symptoms is likely multifacto-rial involving inherent physiological diff erences in response to pain, visceral sensitivity, motility, and autonomic nervous system balance. It is important to understand sensory pathways in GI symptoms and associated physiologi-cal processes in both genders. Evidence linking visceral hypersensitivity to gender diff erences in FGIDs exists, however, the cause is not clear. Th e esophagus is a unique organ with distinct somatic and visceral innervation. Th e distal esophagus perceives visceral pain and the proximal esophagus perceives somatic pain. Th e aim of this study was to compare gender dif-ferences to fi rst sensation to maximum tolerable sensation in proximal and distal esophagus using the Barostat.Methods: Barostat with balloon distention 5 cm above the LES and 3 cm below the UES with endpoints fi rst sensation, fi rst discomfort, and maximum toler-able balloon distention by pressure ramp (mmHg) and by volume step (ml.). Eight (8) male and thirteen (13) female normal subjects participated with 2 procedures performed on each subject. Th e average result was used as the data point for each patient. P-values were determined from t-tests.Results: See Table that shows there are diff erences in sensitivity between males and females at end of text.Conclusion: Gender diff erences in fi rst sensation, fi rst discomfort, and maxi-mum tolerable sensation were dramatic in a small number of normals, illus-trating major diff erences in both somatic and visceral sensitivity in males and females.

79

Gastroenterologists May Inadequately Assess Bone Mineral Density in Patients Maintained on Proton Pump InhibitorsMarie Borum, MD, EdD, MPH, FACG, Deborah Graham, MD, Huy Nguyen, MD, Nitin Sardana, MD. Division of Gastroenterology, Th e George Washington University Medical Center, Washington, DC.

Purpose: Recent studies have shown that patients on long-term proton pump inhibitors (PPIs) are at increased risk for hip fractures. While the exact mecha-nism of how PPIs aff ect calcium absorption and bone reabsorption remains unclear, there have been recommendations for physicians to evaluate bone mineral density (BMD) of individuals maintained on PPI therapy. It is uncer-tain if physicians consistently obtain BMD in this setting. Th is study evaluated the rate at which gastroenterologists obtain BMD testing on patients main-tained on >1 month of PPI therapy.Methods: A retrospective chart review of consecutive patients maintained on PPI therapy who were referred to an urban university gastroenterology practice over a three month period was conducted. Patient age, gender, race and performance of DEXA scan were obtained. A database was created using Microsoft Excel. Statistical analysis was performed using Fisher’s Exact test with significance set at p<0.05. The study was approved by the IRB.Results: 115 patients on PPI therapy >1 month were identifi ed. Th ere were 75 women and 40 men with a mean age of 56.1 years. Th ere were 48 Afri-can-American, 46 whites, 11 Latinos, 3 Asians and 7 patients whose race was not documented. 33 of the 115 (28.7%) were referred BMD testing. Gender analysis revealed that 29 of 75 women (38.7%) and 4 of 40 men (10%) were referred for a DEXA. Th ere was a statistically signifi cant diff erence (p=0.002) in the rate at which women and men maintained on PPIs were referred for BMD testing. Th ere was no signifi cant diff erence (p=0.83) in the rate at which African-Americans and white patients were referred for BMD testing.Conclusion: Studies have shown that prolonged PPI use places patients at risk for osteoporosis and subsequent hip fractures. It is recommended that patients are counseled about the need for BMD testing and supplementa-tion if required. Th is study revealed that there was suboptimal assessment of BMD in patients maintained on PPI for >1 month. Additionally, men were less frequently referred for BMD testing when compared to women. Eff orts are needed to increase physician awareness of potential PPI risks and ensure that all patients receive BMD testing as recommended.

80

Eosinophilic Esophagitis: Epidemiology, Clinical Features and Allergies in the Pediatric Population of Puerto RicoVylma Velazquez, MD, Carlos Camacho, MD, Alfredo Mercado, MD, Jadira Irizarry, MD. Hospital Episcopal San Lucas, Ponce, PR.

Purpose: Describe the demographic characteristics, clinical features and atopic profi le of pediatric patients diagnosed with eosinophilic esophagitis.Methods: Cross sectional study in which 41 records of patients diagnosed with eosinophilic esophagitis by endoscopic and histological fi ndings of biopsies. We conducted an evaluation of age and sex distribution, profi le of symptoms and atopic history of families and patients. Environment and food allergy test-ing of patients were done. Data analyzed.Results: In 41 patients, 53.6% were male and 46.4% were female. Th e median age of the sample was 8 years old. Th e largest age group was 5-10 years old. Th e most common presenting symptoms were abdominal pain with 56% followed by epigastric pain in 34% and gastroesophagic refl ux in 20% of cases. Vomiting was more frequent in children of less than 4 years of age. 80% of patients presented at least one type of allergy. Th ere was a strong family history of allergies and most patients were allergic to environmental allergens, mostly dust mites. Food aller-gies were present in 15% of cases mostly common to milk, egg and wheat.Conclusion: In our population, there was a male predominance as in previous studies in literature. Also most common symptoms were epi-gastric and abdominal pain. Allergies were prevalent in a great proportion of patients in our study, but there was a predominance of environmental

[77]

Comparison of upper and lower esophageal sensation in males and females

Upper Esophagus Lower Esophagus

Males Females P value Males Females P value

P. 1st. Sens 12.66 5.68 0.0156 16.49 9.09 0.0355

P. 1st Disc 25.50 13.97 0.0174 32.20 16.35 0.0033

P. Max Pn 41.17 24.51 0.0152 47.84 30.02 0.0048

V. 1st Sens 8.13 4.04 0.0282 12.81 5.96 0.0099

V. 1st Disc 18.13 9.42 0.0241 27.63 12.88 0.0064

V. Max Pn 38.75 20.00 0.0122 48.44 24.42 0.0010

© 2009 by the American College of Gastroenterology The American Journal of GASTROENTEROLOGY

Abstracts S33

allergies over food allergies as described in literature. Food allergies are outgrown by 5 years of age and that may be the reason of the shift ing of prevalence from food allergies to environmental allergies in these popula-tion of patients.

81

A Distinct Motor Pattern is Responsible for Esophageal Emptying in Achalasia Esophagus Using High Frequency UltrasoundSu Jin Hong, MD,1 Valmik Bhargava, PhD,1 Yanfen Jiang, MD,2 Debbie DenBoer, BS,1 Ravinder Mittal, MD, FACG2. 1. Gasteroenterology, University of California San Diego, San Diego, CA; 2. University of California San Diego, San Diego, CA.

Purpose: Mechanism of esophageal (ESO) emptying in achalasia, character-ized by failure of the lower esophageal sphincter relaxation (LES) and ESO body aperistalsis, is unknown. Th is study was performed to defi ne the ESO and esophageal gastric junction(EGJ) motor patterns using high-resolution manometery (HRM) and high frequency intraluminal ultrasound (HFIUS) imaging to characterize the mechanism of ESO emptying in these patients.Methods: Using HRM, we assessed swallow-induced pressure changes in esophagus, upper esophageal sphincter(UES) and esophageal gastric junc-tion (EGJ) over 12 s period, (2 before, 10s aft er swallow). ESO pressure, peak EGJ pressure, ESO length (UES to EGJ), UES length and common cavity (CC) length were determined. ESO emptying was assumed when ESO and EGJ pres-sures were equal or impedance study confi rmed fl ow across the EGJ. HFIUS and HRM with impedance recordings were synchronized and analyzed at 2 and 10 cm above the EGJ.Results: 5 swallows were selected randomly from each of the 32 patients and 160 swallows were divided into pattern A (25 swallows/9 patients), B (113 swallows/25 patients), and C (22 swallows/5 patients) (Figure 1). Pattern B swallows were followed by increase in ESO pressure, associated with or without emptying. Mechanism of ESO pressure increase of pattern B swallow was due to a decrease in ESO length, CC length or a combina-tion. Decrease in ESO length was related to UES descent, LES ascent or a combination. Decrease in CC length is related to the above+increase in UES length+contracted proximal segment of esophagus. HFIUS showed increase in muscle cross sectional area (CSA), marker of longitudinal muscle contraction), both at 2(46%) (Figure 2) and 10 cm (17%) above the EGJ during increase in ESO pressure. CSA increase was signifi cantly smaller at 10 com-pared to 2 cm level.Conclusion: ESO shortening due to longitudinal muscle contraction is the major mechanism of ESO pressure increase and ESO emptying in patients with achalasia.

82

Retrospective Assessment of Immediate-Release Omeprazole/Sodium Bicarbonate in Improvement of GERD Symptoms in Patients Who Failed Delayed-Release Proton Pump InhibitorsJohn Jolley, MD. University of California, San Francisco, CA.

Purpose: Prior open-label, randomized crossover studies have shown that immediate-release omeprazole (IR-OME) is more eff ective in controlling nighttime and daytime intragastric acidity compared with delayed-release pro-ton pump inhibitors (DR-PPIs). Because of its unique formulation, IR-OME does not require pre-meal dosing, allowing for bedtime dosing to control noc-turnal intragastric acidity.Methods: Th is study was an open-label retrospective review of patients’ medical records (01 Jan 06 to 31 Dec 08), which evaluated the eff ectiveness of IR-OME in relieving GERD symptoms in patients who failed one or more DR-PPIs. Patient records were selected by GERD diagnosis, DR-PPI treatment

[81] Figure 1: HRM patterns of ESO contraction.

[81] Figure 2: HRM, M-mode HFIUS image and CSA plot.

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AbstractsS34

(≥ eight weeks) with inadequate symptom relief, and treatment with IR-OME 40 mg at bedtime. Medical records of 50 patients (33 females [66%]) were reviewed and included in this study.Results: Forty-fi ve patients (90%) were ≤ 65 years of age. Mean age was 51.40 years±19.47 and median treatment for 8 weeks (4 to 20 weeks). Results aft er IR-OME treatment showed 47 patients (94%) had improvement or resolu-tion of GERD symptoms, classifi ed according to the Montreal Defi nition and Classifi cation of GERD (Table). Age or sex did not aff ect treatment outcome. Patients had undergone treatment with one (n=30, 60%), two (n=15, 30%), and three or more (n=5, 10%) DR-PPIs. Among patients who had taken ≥ two DR-PPIs, 19 (95%) had resolution, while one (5%) had improvement of GERD symptoms with IR-OME. Among patients who had taken one prior DR-PPI, 24 (80%) had resolution, while 3 (10%) had improvement, and 3 (10%) had wors-ening or no change of GERD symptoms aft er IR-OME. One (2%) patient who had worsening or no change later underwent biopsy and was diagnosed with eosinophilic esophagitis. One patient (2%) discontinued IR-OME because of nausea, tingling, and lightheadedness, and was re-treated with her prior DR-PPI. No other AEs were reported.Conclusion: Th is study suggests that IR-OME is well tolerated and eff ective in controlling GERD symptoms aft er inadequate relief with DR-PPIs.Disclosure: Santarus: Speaker’s Bureau, Grant Support.Th is research was supported by an industry grant from Santarus.

83

Long Term Placement of Self-expanding Plastic Stents is Safe for Benign Esophageal DiseaseRuben Acosta, MD,1 William Norris, MD,2 Bruce Greenwald, MD3. 1. Gastroenterology, National Naval Medical Center, Bethesda, MD; 2. Walter Reed Army Medical Center, Washington DC, DC; 3. University of Maryland, Baltimore, MD.

Purpose: Removable self-expanding plastic stents (SEPS) are used for the short-term treatment of benign esophageal diseases including strictures and esophageal fi stulae. Th e purpose of this study was to determine the effi cacy and safety of SEPS left in place for greater than 90 days for benign esophageal disease.Methods: Patients receiving a SEPS from 2003-2009 for benign esophageal disease at a single university center were retrospectively identifi ed using an endoscopic database (Provation Medical, Minneapolis, MN). Patients with a stent left in place for more than 90 days were included in this study. Indication for stent placement, stent size, duration of stent placement, fol-low-up endoscopy and imaging studies, and the effi cacy of treatment were collected.

Results: Nine patients were included. Indication for stent was benign stric-ture refractory to dilation (8) or esophageal fistula (1). Cause of the stricture was esophagectomy (7), esophageal Castleman’s disease (1). Median age was 53.4 years; 8 were males. SEPS placement was successful in all patients. Th e median stricture length was 2 cm (range 1-8 cm). Stents were left in place for 3-34 months (median 11). In 7, the stent was removed without diffi culty. Six received a second stent for stricture recurrence. Th e most commonly used stent had a diameter of 18mm. Follow-up EGD was performed in eight patients. One patient had stent placement confi rmed aft er 23 months by a CT scan. Stent migration occurred in 3 patients. Th e most common endo-scopic fi nding was granulation tissue adjacent to the proximal or distal stent margin. One stent migrated proximally into the proximal esophagus, causing ulceration and stricture requiring dilation. In another patient with proximal stent placement for 27 months, a trachea-esophageal fi stula developed aft er stent removal, requiring placement of a new stent and jejunostomy tube.Conclusion: SEPS can be safely left in place for greater than 3 months in some patients with benign esophageal disease refractory to other treatments. Complications developed in those with proximal esophageal placement. Stent migration was seen in 3/9 (33.3%) of patients.

84

EMR Aft er EMR: Can a Second EMR be in the Region of Prior EMR?2009 Presidential Poster

Yutaka Tomizawa, MD, Ngozi Okoro, MBBS, Ganapathy Prasad, MD, Louis Wong Kee Song, MD, Navtej Buttar, MD, Lynn Borkenhagen, NP, Lori Lutzke, CCRP, Kelly Dunagan, RA, Kenneth Wang, MD, FACG. Mayo Clinic, Rochester, MN.

Purpose: Endoscopic mucosal resection (EMR) has been found to be impor-tant in the diagnosis and treatment of Barrett’s esophagus (BE). However, there has been a concern about its use aft er prior EMR. Prior resection gener-ating fi brosis could make subsequent EMR more technically diffi cult. Our aim is to examine if prior EMRs aff ect the risk and ability to perform subsequent EMR.Methods: Th is is a retrospective cohort study from a tertiary referral insti-tution. Patient demographics and clinical outcome were extracted from a prospectively maintained database. 99% of sessions were performed by a single experienced endoscopist using standard techniques. Patients were divided into two groups, those that only had a single EMR session and those that underwent a second EMR session in the region. Th e overall occurrence

GERD symptoms and IR-OME treatment

N

Worsened or no change,

n ( % ) Improved,

n ( % ) Resolved,

n ( % )

Overall resolution, (improved +

resolved) n ( % )

Esophageal symptoms

30 2 (6.7) 28 (93.3) 28 (93.3)

Extraesophageal symptoms

16 2 (12.5) 14 (87.5) 16 (100.0)

Both esophageal and extraesopha-geal symptoms

2 1 (50.0) 1 (50.0) 2 (100.0)

Eosinophilic esophagitis

1 1 (100.0)

Eosinophilic esophagitis with typical refl ux syndrome

1 1 (100.0) 1 (100.0)

Total 50 3 (6.0) 4 (8.0) 43 (86.0) 47 (94.0)

Subject Stricture type (PS=Post-Surgical)

Duration stent in place (Months) Outcomes

1 PS, Radiation 34 Alive, stent in place

2 PS, Fistula 7 Died, complications of esophago-pulmonary fi stula

3 PS 6 Dilations (36) over 8 months, now stricture free

4 PS 3 Died of recurrent cancer, stent in place

5 PS 23 Died of metastatic disease, stent in place

6 Castleman’s 7 Dilations (6) over 44 months due to recurrent stricture

7 PS 5 Stent prox migration with ulcer-ation and stricture, requiring periodic dilation and feeding tube placement

8 PS 27 Alive, stent in place

9 PS 13 Alive with metastatic cancer, stent in place by CT

© 2009 by the American College of Gastroenterology The American Journal of GASTROENTEROLOGY

Abstracts S35

of perforation, bleeding and stricture in all EMR procedures were assessed as outcomes with variable modifying factors (age, mean length of BE, num-bers of EMR, usage of NSAIDs and usage of anticoagulants). We excluded those with any other intervening therapies than EMRs (such as PDT and RFA). We compared the complications and the size of the EMR between these two groups.Results: Records of 681 patients (562 male, mean age 70 yo, mean length of BE 3.0 cm) who underwent 1388 sessions of EMR from 1995-2008 were reviewed. A total of 2513 EMRs were performed. EMR was performed using the Olympus EMR kit in 77% of cases, band & snare technique in 5% and Wilson Cook duette kit in 18%. Number of EMRs/session increased over the time interval. Stricture rate decreased over the time interval. Th ere were no perforations. Overall, bleeding related to EMR occurred in 8 sessions (0.58%) and strictures due to EMR were found in 7 sessions (0.50%). We assessed if any variable modifying factors aff ected on bleeding or stricture by uni-variate analysis, but there were no signifi cant correlations on the bleeding or stricture. 935 sessions were only EMRs without any other treatments. Solo EMRs were performed in 515 sessions and 420 sessions had a follow-up EMR done. Bleeding (5) and stricture (2) were found in the solo EMR, respectively, whereas in the follow-up EMR group had 3 bleeds and 5 strictures. Th ere were no signifi cant diff erences in the occurrences of both bleeding (p=0.74) and stricture (p=0.25) between the two groups. Th e mean size of the resected specimens was 1.1 cm in the solo EMRs and 0.9 cm in the follow-up EMR (p<0.05).Conclusion: This is the first report assessing the effect of prior EMR on the complication of EMR procedure from a high volume specialized unit. Our study showed there were no significant differences in the rate of com-plications between the first EMR and the subsequent EMR after initial EMR.

85

Prospective Analysis of Esophageal Eosinophil Peroxidase(EPX) Staining in Pediatric Eosinophilic Esophagitis: Final ResultsRayna Grothe, MD,1 Brock Doubledee, DO,3 Gary Neidich, MD,3 Cheryl Protheroe, BA,2 James Lee, PhD,2 Yvonne Romero, MD,1 Felicity Enders, PhD1. 1. Mayo Clinic, Rochester, MN; 2. Mayo Clinic, Scottsdale, AZ; 3. Sanford USD Medical Center/Children’s Hospital, Sioux Falls, SD.

Purpose: Background: Th e diagnosis of eosinophilic esophagitis (EoE) is based on the histologic fi nding of ≥20 eosinophils/high powered fi eld (eos)/hpf in esophageal biopsies collected at upper endoscopy (EGD). Our objec-tive was to determine if the eosinophil granular protein eosinophil peroxidase (EPX) correlated with ≥20 eos/hpf and could be used to accurately determine the presence and severity of EoE in pediatric patients.Methods: Prospective, multi-center, nested case-control study of outpatients (ages 1 to 17 years) at Sioux Valley Hospital, SD, and Mayo Clinic, MN, sched-uled to undergo EGD to evaluate vomiting, failure to thrive, feeding aversion, abdominal pain, or dysphagia. All eligible clinical patients were invited to par-ticipate. Subjects whose guardians gave written informed consent underwent a clinically indicated EGD, with histology held as the gold standard. Subjects with ≥20 eos/hpf are cases; subjects with zero eos/hpf are controls. Cases and controls were age and sex matched. Investigators were blind to case/control status. All cases and controls underwent anti-eosinophil peroxidase mono-clonal antibody (EPX-mAb) based immunochemistry staining of esophageal biopsies with assessment of intact eosinophils and degranulation with EPX. Preliminary EPX results on the fi rst 6 subjects were reported at the NASP-GHAN World Congress August 2008. Th e following is the complete analysis of case and controls.Results: N=20 cases [12 males; mean age 7.6 yrs (range 15 mos to 17 yrs)], N=20 controls [12 males; mean age 7.6 yrs (range 13 mos to 17 yrs)]. Intact eosinophils were observed with EPX in 20/20 cases and 1/20 controls (p<0.0001). Degranulation was observed in 18/20 cases and 1/20 controls (p<0.0001).Conclusion: Results suggest that positive esophageal EPX correlates with ≥20 eos/hpf on esophageal biopsy. Degranulation is observed with EPX in the majority of EoE cases, although one control did show degranulation in the

absence of positive EPX eosinophil staining. Further studies are required to delineate the possible role of EPX degranulation in prospectively distinguish-ing EoE from other causes of esophageal eosinophilia in children as well as in detecting “evolving” EoE.

86

Eosinophilic Esophagitis and Barrett’s Esophagus: A Study of 31 PatientsIulia Platte, MD, MHA, Mihaela Batke, MD, Mitchell Cappell, MD, PhD, FACG, Michael Duff y, MD, FACG, Tusar Desai, MD, FACG. William Beaumont Hospital, Royal Oak, MI.

Purpose: Eosinophilic esophagitis (EE) is a relatively new entity in the spec-trum of gastroenterological diseases, and its clinical features continue to be characterized. To date, no association with Barrett’s esophagus (BE) has been described in adults. Th e aim of this study was to present the clinical character-istics of 31 patients with EE and BE.Methods: A retrospective analysis of the pathology database of a large commu-nity hospital for the interval January 1, 2006 through December 31, 2008 was performed. Th irty-one patients with concurrent EE and intestinal metaplasia were identifi ed using the key words “esophagus,” “eosinophilic,” “Barrett’s,” and “metaplasia.”Results: Most patients were male (74%). Th e mean age was 55.4 years (range 8-86 years). More patients were diagnosed in spring and summer (19/31), but this was not statistically signifi cant (p=0.65). For 18 patients, both the diagno-sis of EE and of BE was made for the fi rst time. Eleven patients had a previous diagnosis of BE for 1-9 years, and 2 patients had a previous diagnosis of EE for 1-6 years. Fift een patients had prior endoscopies and 11 patients had a total of 17 follow-up endoscopies. On follow-up, 6/11 patients continued to have both EE and BE on biopsies, and overall both BE and EE were present in 6/17 biop-sies. Twenty-nine percent of patients had long-segment BE, 58% had short-segment BE, and in 13% BE was not suspected at endoscopy. Rings or furrows were identifi ed in 7 of the 31 endoscopies. Sixty-one percent of patients had a hiatal hernia, and 25% had a Schatzki ring. Th e indication for endoscopy was gastroesophageal refl ux or Barrett’s screening in most patients; dysphagia was listed as an indication in only 8, and food impaction in 2 patients.Conclusion: Th is is the fi rst reported series of patients with concurrent EE and BE. As expected, most patients were middle-aged men, but the youngest patient was only 8 years old. Th irty-fi ve percent of patients had known BE when EE was diagnosed. Only a few patients had follow-up endoscopy, and only half of those continued to have both EE and BE on biopsy. Both BE and EE had a fl uctuating clinical course, being only intermittently identifi ed on biopsy specimens.

87

Esophageal Manometric Findings Among Patients with Esosinophilic EsophagitisYoung Choi, MD, Shilun Li, MD, Sheri Long, LPN, Kathy Kukacka, LPN, Holly Noy, LPN, Panagiotis Panagiotakis, MD, Meher Rahman, MD. Gastroenterology, ISJ Clinic, Mankato, MN.

Purpose: Eosinophilic esophagi is (EE) is histologically defi ned as greater than 20 intraepithelial eosinophils in a high power fi eld (Attwood SE et al., 1993). Many with EE present with food impaction and dysphasia. Despite these symptoms, there have not been any esophageal manometric studies in these patents. Th erefore, we attempted to gather esophageal motility data among those diagnosed with EE.Methods: We reviewed four patients with EE. Th ree patients had prior his-tories of EGD without clear diagnosis and had one or more episodes of food impactions. One patient had refractory refl ux. All patients were male; three were 33 years old and one was 32 years old. Th ey all underwent Sierra High-Resolution Esophageal Motility studies (SHREM). Later EGD’s were repeated and they all met the histological criteria for EE.Results: Th e EGD of the patient who only had refractory refl ux had grossly normal esopahgus. Th ree others had histories of one or more episodes of food impactions and had endoscopic fi ndings of mucosal friability, felinization of the

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AbstractsS36

esophagus, and small esophageal caliber. Esophageal biopsies on all four subjects showed 25-100 eosinophils per high power fi eld. Th e SHREM on the patient who had refl ux showed high peristaltic amplitudes waves (>200 mm Hg) with normal LES function. Th ose with histories of food impactions had SHREM showing signifi cantly impaired esophageal peristalsis i.e. ineff ective peristalsis (<30 mm Hg), simultaneous contractions, and/or aperistalisis.Conclusion: In this small study, all patients with eosinophilic esophagitis had abnormal manometric fi ndings. Th ose who presented with food impactions and dysphasia tended to have gross abnormalities in esophageal mucosa and impaired esophageal peristalsis. Th erefore, impaired peristalsis may contribute to the food impaction.

88

Barrett’s with High Grade Dysplasia: Endotherapy vs. Observation OnlyXinqing Fan, MD,1 Jeff ery Lee, MD2. 1. Gastroenterology, University of Texas Southwestern Medical Center, Dallas, TX; 2. University of Texas MD Anderson Cancer Center, Houston, TX.

Purpose: Th e incidence of esophageal adenocarcinoma complicating Barrett’s esophagus is increasing in the United States and western countries in the past two decades. Endoscopic ultrasound (EUS) has been shown to provide the most accurate locoregional staging for esophageal adenocarcinoma. However, utility of EUS in Barrett’s (BE) with high grade dysplasia (HGD) is still unclear. Th e natural history of BE with HGD is also undefi ned. Th e aims of this study were to evaluate the utility of EUS in BE with HGN and to investigate the out-comes of endotherapy of BE with HGD.Methods: A retrospective review of patients who underwent EGD/EUS was done for the period of 2005 to 2008. A database containing the fi ndings of upper endos-copy (EGD), EUS, age, gender, race information was created and analyzed.Results: 46 patients with diagnosis of BE with HGN were identifi ed. Two patients were excluded as they were lost in follow-up. Th e mean age of the 44 patients was 68±11 (mean±SD) with 39 being male. Demographics were 37 white, 5 Hispanic, and 2 African-Americans. 21/44 had nodular mucosa within BE; 6/21 (29%) were found to have adenocarcinoma (ACA)(5 with T1N0 and 1 with T2N0 ). 15/21 had normal EUS. 23/44 were without a nodule or nodular mucosa. In 12 patients with HGD were treated with PDT (7 patients), RFA (5 patients) or either modality combined with endoscopic mucosal resection (EMR)(3 patients), no ACA was found in follow-up of 30 months. In 22 patients with HGD who were followed under surveillance program, ACA was found in 8 in 30 months. No statistical diff erence was found in the length of BE or the size of hiatal hernia between patients with and without ACA (P>0.05, student T-test). However, nodular mucosa was a signifi cant risk factor in developing ACA (P<0.01, �2 test).Conclusion: EUS is useful in evaluating HGD in patients with focal nodule or nodular mucosa within BE. Focal nodule or nodular mucosa within the BE mucosa increase the risk of ACA. Th e endotherapy utilizing EUS staging, EMR, PDT, RFA may alter the natural progression of BE with HGD.

89

Comparison of Electron Microscopy vs. Light Microscopy for Diagnosing GERD in Patients with Refractory HeartburnBrandon Craft , MD, David Lewin, MD, Janice Freeman, RN, Debra Hazen-Martin, PhD, Marcelo Vela, MD, FACG. Department of Medicine, Medical University of South Carolina, Charleston, SC.

Purpose: In patients with ongoing heartburn despite acid suppression with PPIs, especially in the absence of endoscopic changes, the diagnosis of GERD is challenging and oft en requires prolonged refl ux monitoring. Histological changes attributed to refl ux in esophageal biopsies examined by light micros-copy (LM) are suboptimal for diagnosing GERD. Dilation of intercellular space distance (ISD) in esophageal epithelium assessed by electron microscopy (EM) is emerging as a robust marker of GERD. Our aim was to compare the sensitiv-ity and specifi city of EM vs. LM for the diagnosis of GERD in patients with persistent heartburn despite PPI.

Methods: Patients with persistent heartburn despite PPI BID underwent 24 hr-hr ambulatory impedance-pH (MII-pH), and endoscopy (EGD) with biop-sies 5 cm above the Z line for analysis by EM and LM. Two schemes with dif-ferent rigor used to diagnose GERD: “rigorous criteria” were esophagitis on EGD or abnormal MII-pH defi ned by increased esophageal acid exposure; “less rigorous criteria” added positive symptom index (>50% symptoms asso-ciated with refl ux) to defi nition GERD. In both schemes, functional heartburn patients (FH) had normal EGD and MII-pH. Intercellular space distance (ISD) determined blindly by EM at 5,000 magnifi cation using computer-assisted morphometry (Image J soft ware). 10 ISD measurements taken in each of 10 micrographs, mean ISD was the average of 100 measurements. Upper limit of normal ISD was 0.68 μm (the 95th percentile ISD in ten healthy volunteers with normal pH-metry). Light microscopy evaluation performed by single, blinded gastrointestinal pathologist aft er routine hematoxylin and eosin stain-ing, who provided a diagnosis of GERD based on rete papillae elongation or basal cell hyperplasia. Th e sensitivity and specifi city of EM and LM for GERD were then compared.Results: Use of the more rigorous EGD/MII-pH criteria yielded 6 GERD and 16 FH patients; sensitivity and specifi city were 83% and 88% for EM, 67% and of 44% for LM. Th e less rigorous criteria yielded 12 GERD and 10 FH patients; sensitivity and specifi city were 58% and 100% for EM, 67% and 50% for LM. Specifi city for GERD appears good for EM and poor for LM. Sensitivity is fair and comparable for EM and LM using less rigorous criteria for GERD, sensi-tivity is better for EM compared to LM when using more stringent criteria.Conclusion: Increased intercellular space distance measured by Electron Microscopy has good specifi city and is thus very reliable (and superior to LM) for excluding GERD in patients with refractory heartburn, provid-ing good accuracy for the diagnosis of functional heartburn. EM has good sensitivity, especially in patients with GERD diagnosed by more rigorous criteria.

90

Establishing the Normal References of High-Resolution Esophageal Mano-metric Measurements in Southeast Asian Population: A Pilot ProjectMarilyn Li, MD, FRCPC, Louis Liu, MEng, MD, PhD, FRCPC. Gastroenterology, University of Toronto, Toronto, ON, Canada.

Purpose: Th e aim of our pilot study is to provide preliminary data to form high resolution manometry (HRM) reference values for a Southeast Asian popula-tion. A secondary objective is to detect if variables, such as patient position, infl uence esophageal manometric profi les.Methods: We performed esophageal manometry on 23 consecutive, asymp-tomatic patients using HRM. HRM was performed using the A100 esophageal manometry probe for ManoScan 360 (Sierra Scientifi c). Measurements were taken at rest and with 10 wet swallows, using 5 cc water boluses in both the upright and supine (head inclined at 30 degree) positions. Data were analyzed using ManoView (Sierra Scientifi c) and Excel (Microsoft ) soft ware packages. Mean values for LES basal pressure, esophageal length, wave ampliture pres-sure front velocity, and distal contractile integrals were calculated.Results: A total of 23 asymptomatic Southeast Asian patients were evalu-ated. Th e mean LES basal pressures were 12.9 and 19.4 mm Hg, mean esoph-ageal lengths were 26.5 and 25.0 cm, mean wave amplitudes were 74.2 and 82.9 mm Hg, mean pressure front velocities were 3.4 and 1.9 cm/s, and mean distal contractile integrals were 4140.7 and 7987.8 mm Hg cm s, in the upright and supine positions respectively. Th ese were consistently within the Chicago Classifi cation. Secondly, in the supine position compared to upright, esophageal lengths were shorter, wave amplitudes stronger, pres-sure front velocities slower, and distal contractile integrals larger, but not signifi cantly.Conclusion: Th e normal reference ranges for HR esophageal manometry in Southeast Asian patients do not seem to diff er from the established Chicago Classifi cation. HR measurements in the supine position trends towards stron-ger contractions and slower velocities, suggesting that a standardized protocol should be adopted at centres performing HRM. Larger prospective studies are needed to validate fi ndings of this pilot study.

© 2009 by the American College of Gastroenterology The American Journal of GASTROENTEROLOGY

Abstracts S37

91

Management Based Upon pH-Multichannel Intraluminal Impedance (MII) Results Varies Signifi cantly Between Patients and Across Age GroupsRyan Madanick, MD,1 Serena Ezzedine, MD,2 Evan Dellon, MD, MPH,1 Sima Patel, MD,2 Douglas Morgan, MD, MPH,1 Nicholas Shaheen, MD, MPH1. 1. Division of Gastroenterology & Hepatology, UNC School of Medicine, Chapel Hill, NC; 2. UNC Hospitals, Chapel Hill, NC.

Purpose: pH-MII testing is commonly used in patients who do not respond to therapy for gastroesophageal refl ux disease (GERD). However, the resulting change in management is not well documented. Th e aim of this study was to describe the actions taken by physicians as a result of pH-MII testing at a large tertiary care center.Methods: Data from all pH-MII studies performed since 2006 were abstracted. Studies were classifi ed as abnormal acid (% time pH <4≥4.2% total, 6.3% upright or 1.2% supine off acid suppression; ≥1.3%, 1.5%, or 0.5%, respectively, on acid suppression), abnormal nonacid (≥73 refl ux events with normal acid exposures off acid suppression; ≥48 events with normal acid exposures on acid suppression), hypersensitive (normal acid exposures, nor-mal number of refl ux events, and symptom index ≥50% for primary symp-tom), negative (normal acid exposures, normal number of refl ux events, & symptom index < 50% for primary symptom) or failure (study not interpre-table due to probe failure or brief duration).Results: 393 studies were performed in 375 patients (154 M/221 F; age 1 mo-87.7 yr) between Feb 2006 and Oct 2008. Sixty-three percent of patients had at least one physician action documented as a result of the fi ndings (69% if positive for acid or non-acid; 54% for hypersensitive or negative studies; Table 1). Among those with positive studies, the most common action was a change in acid suppression (33%) or fundoplication (26%). Of patients with positive studies (and at least one follow-up encounter), 20% had no change in their refl ux therapy. Among those with negative or hypersensitive studies, the most common actions were no change in therapy (34%), addition/alteration of a centrally acting neuromodulator (26%), or a change in acid suppression (23%). When the results were stratifi ed by age (Table 2), infants who had abnormal studies were signifi cantly more likely (48%) to undergo a fundoplication than children (29%) or adults (21%) (p=0.01), whereas infants were signifi cantly less likely (11%) than children (29%) and adults (37%) to receive a change in their acid suppressive therapy (p=0.03). Of adults with positive studies, 15% had a centrally-acting neuromodulator added/altered, compared with only 3% of children and 0% of infants (p=0.02). Of children, 35% had no change in their refl ux related therapy, compared with 19% of infants and 16% of adults (p=0.04).

Conclusion: Th e response to pH-MII fi ndings at a large tertiary care center was varied, irrespective of test result. In most patients, a specifi c change in management occurred, however 20% of patients with positive fi ndings had no change. Infants who had a positive pH-MII test were more likely to undergo fundoplication than were children or adults.

92

Endoscopic Mucosal Resection of High Grade Dysplasia (HGD) and Early-Stage Esophageal Adenocarcinoma Using the ‘Ligate and Cut’ Technique with the Multi-band Mucosectomy DeviceRyan Pyles, DO, Ananya Das, MD, Giovanni DePetris, MD, Cuong Nguyen, MD, FACG, H. Jae Kim, MD, David Fleischer, MD, Virender Sharma, MD, FACG. Mayo Clinic Arizona, Scottsdale, AZ.

Purpose: Background: Th e multi-band mucosectomy device facilitates the per-formance of endoscopic mucosal resection (EMR) using the ‘ligate and cut’ tech-nique. We report our experience of performing endoscopic resection for high grade dysplasia and early-stage esophageal adenocarcinoma with this device.Methods: Adult patients (52 males, 7 females; mean age of 70; range 44-89) with Barrett’s esophagus complicated by development of focal nodular HGD or early-stage esophageal adenocarcinoma who refused or were not candidates for surgery. EMR was performed using the multi-band mucosectomy device in an outpatient setting. Eff ectiveness of the procedure was evaluated in terms of complete clear-ance and recurrence. All procedural adverse events were also recorded.

[91] Table 1 . Actions taken by test result

Abnormal acid Abnormal non-acid Hypersensitive Negative Failure A + NA H + N All studies ( n =172) ( n =32) ( n =35) ( n =141) ( n =14) ( n =203) ( n =176) ( n =393)

Change acid suppression 34 % 25 % 34 % 20 % 14 % 33 % 23 % 27 %

Add promotility agent 4 % 9 % 6 % 2 % 0 % 5 % 3 % 4 %

Add baclofen 2 % 9 % 11 % 1 % 0 % 3 % 3 % 3 %

Add / change central neuro-modulator

11 % 13 % 26 % 26 % 0 % 11 % 26 % 17 %

Add / change peripheral neuro-modulator

1 % 3 % 6 % 5 % 0 % 1 % 5 % 3 %

Repeat study 4 % 3 % 6 % 1 % 29 % 4 % 2 % 4 %

Fundoplication 26 % 25 % 6 % 4 % 14 % 26 % 5 % 16 %

Other 3 % 9 % 6 % 7 % 0 % 4 % 7 % 5 %

No change 19 % 25 % 20 % 38 % 43 % 20 % 34 % 27 %

Unknown 13 % 3 % 9 % 10 % 0 % 11 % 10 % 10 %

A + NA: Abnormal acid and nonacid studies combined; H + N: Hypersensitive and Negative studies combined.

[91] Table 2 . Actions taken among pts with abnormal acid or non-acid study

Infants Children Adults (n=27) (n=34) (n=142)

Change acid suppression 11 % 29 % 37 %

Add promotility agent 7 % 3 % 5 %

Add baclofen 0 % 0 % 4 %

Add / change central neuromodulator 0 % 3 % 15 %

Add / change peripheral neuromodulator

0 % 3 % 1 %

Repeat study 0 % 3 % 5 %

Fundoplication 48 % 29 % 21 %

Other 0 % 6 % 4 %

No change 19 % 35 % 16 %

Unknown 15 % 6 % 12 %

Am J Gastroenterol 2009; 104:S37–S59; doi:10.1038/ajg.2009.492

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AbstractsS38

Results: A total of 59 patients with Barrett’s esophagus underwent endo-scopic resection of focal nodular lesions (mean diameter=13 mm). Th irty-one (53%) of these had early-stage (T1N0M0) esophageal adenocarcinoma and 17 (29%) had HGD. In 42 patients (82%), complete clearance was achieved and no major complications were encountered including the 25 patients who had been previously treated with either radiofrequency ablation (RFA) or photody-namic therapy (PDT). Two patients required endoscopic clips and one patient required epinephrine injection for minor intra-procedure bleeding. Th ose patients with incomplete clearance of HGD or adenocarcinoma in the resected specimens were treated by additional EMR or other endoscopic therapy (RFA for HGD; PDT for early-stage esophageal adenocarcinoma). Th ere was recur-rence of the early-stage esophageal adenocarcinoma in 4 patients (7%) over a median follow-up period of 20 (range=7-27) months.Conclusion: In combination with other ablative techniques, EMR with the multi-band mucosectomy device is a safe and eff ective treatment in patients with focal nodular HGD and early-stage esophageal adenocarcinoma.Disclosure: Dr Virender K. Sharma - Research support from Barrx Medical.

93

Concordance Between Liquid and Viscous Esophageal Manometry and Impedance in Patients with Non-obstructive Esophageal DysphagiaEllen Stein, MD, Philip Katz, MD, FACG, R. Gideon, BA. Gastroenterology, Albert Einstein Medical Center, Philadelphia, PA.

Purpose: Esophageal manometry is the traditional method for evaluating non-obstructive dysphagia, but only measures peristaltic sequence. Impedance allows for measurement of bolus movement, and when combined with manometry off ers additional information in these patients. We have performed combined manometry/impedance in all patients with non-obstructive dysphagia using both liquid and viscous media since 2006. Th e fi rst 58 patients in which this approach was used were analyzed for concordance in diagnosis for liquid and viscous media.Methods: We reviewed all charts of patients between 2006 and 2008, and we examined the manometric and impedance fi ndings of 58 consecutive patients with esophageal dysphagia as their primary symptom. We excluded patients with classic achalasia, since they did not receive viscous media during routine testing in our laboratory. Liquid and viscous manometry and impedance were compared separately and then in combination. Esophageal contractions and motility disorders were classifi ed using previously published criteria. Concor-dance was defi ned as agreement between liquid and viscous fi ndings.Results: 72% of patients were female. Th e patients had a variety of diagnos-tic fi ndings based on manometry/impedance: 40% normal, 33% Ineff ective Esophageal Motility, and 24% Distal Esophageal Spasm, 3% Nutcracker. Con-cordance of manometry between liquid and viscous fi ndings was 67%. Con-cordance of impedance between liquid and viscous results was 67%. Overall, combined manometry and impedance showed 50% concordance between liq-uid and viscous fi ndings.Conclusion: Our data reveal less than optimal concordance between liquid and viscous manometry and impedance. Th e clinical importance of these fi nd-ings will require prospective study to more fully assess their signifi cance.

94

Have Referral Patterns to Esophageal Laboratories Changed Over Time? A Study of Esophageal Manometry in 2008 Compared to 1987Ellen Stein, MD,1 Stacey Zavala, MD,1 Satish Kedika, BS,2 R. Gideon, none,1 Philip Katz, MD, FACG1. 1. Albert Einstein Medical Center, Philadelphia, PA; 2. Th omas Jeff erson University, Philadelphia, PA.

Purpose: Compare distribution of specifi c esophageal motility abnormalities and reason for referral to a tertiary esophageal function laboratory in 2008 compared to twenty years ago.Methods: A retrospective review was conducted of patients referred to our esoph-ageal function laboratory from July 2003 to June 2008 (Group A). Th e primary symptom for referral was identifi ed. Th e distribution of motility fi ndings, were compared to a prior study conducted by the senior author in 1987 (Group B). Patients were grouped into 3 categories based on primary symptom; dysphagia,

noncardiac chest pain, and other (e.g. globus, cough, heartburn, etc.), the latter of which was not included in the fi nal analysis as this was not reported in 1987. Th e manometric diagnosis for each patient was classifi ed as Normal, Achalasia, Distal esophageal spasm (DES), hypocontractile motility disorder (Ineff ective Esophageal Motility [IEM] and/or low LES pressure) and hypercontractile motil-ity disorder (nutcracker and/or high LES pressure). Th ese results were then com-pared to the data obtained from a large review published by Katz et al (Annals Int Med, 1987) of 1161 patients with noncardiac chest pain or dysphagia and similar manometric classifi cations. In 1987, patients with hypocontractile motil-ity disorders were labeled as Nonspecifi c esophageal motility disorder. By today’s criteria, they are suffi ciently similar to be so classifi ed. Statistics: Chi-Square test to compare groups A to B. A p-value <0.05 is statistically signifi cant.Results: 1263 studies reviewed; other (N=490), dysphagia and chest pain (see Table).Conclusion: Reason for referral for esophageal function testing has substan-tially changed dramatically compared to 1980s. Dysphagia (and other) symp-toms predominate over chest pain. Th ere is a signifi cant increase in the number of abnormal studies and distribution of motility abnormalities likely refl ective of the change in referral pattern.

95

Inter-Observer Agreement for Symptom Associated Description and Char-acteristics of Skilled Related Interpretation Time in Impedance-pH TestingJason Roberts, MD, Erick Singh, MD, Jason Wilson, MD, Neeraj Sharma, MD, Donald Castell, MD, FACG. Medical University of South Carolina, Charleston, SC.

Purpose: Background: Combined multichannel intraluminal impedance—pH (MII-pH) is the gold standard for monitoring refl ux. Interpreting the data col-lected from a 24 hour ambulatory study with this technology requires more time and experience than conventional pH only studies. Despite its increasing use, little is known about the inter-observer variability or the “learning curve” for novice readers, the accuracy, and the time to read these studies. Aim: Th is study evaluates the accuracy, inter-observer variability, and time to read in readers with varied skill levels.Methods: Single center, prospective, blinded randomized controlled trial. Readers (n=4) were divided into novice (n=2), intermediate (n=1), and expert (n=1) groups. Th e fi rst consecutive 40 MII-pH studies were independently interpreted by each reader. Th e results included: number of impedance detected refl ux episodes (acid and non-acid), symptom index (SI), symptom association probability (SAP), and time to read the study. STATISTICAL ANALYSIS: Th e inter-reader agreement for impedance results was assessed by Cohen’s kappa. Th e distribution of positive or negative SI and SAP calculation were compared between readers using the Fisher’s exact test. Th e time to read was compared among groups using the ANOVA test.Results: 40 MII-pH studies analyzed in this study included 29 patients on a PPI. Th e number of refl ux episodes was (median; 25%-75%) 38, 20-51; 25,

Normal Achalasia DES Hypocon-tractile

Hypercon-tractile

Dysphagia

Group A ( N =566)

160 (28 % ) 180 (32 % ) 48 (8 % ) 110 (19 % ) 68 (12 % )

Group B ( N =251)

119 (47 % ) 48 (19 % ) 17 (7 % ) 51 (20 % ) 16 (6 % )

* P < 0.05 * P < 0.05 P =0.42 P =0.74 * P =0.01

Chest pain

Group A ( N =207)

111 (53 % ) 5 (2 % ) 22 (11 % ) 47 (23 % ) 22 (10 % )

Group B ( N =910)

655 (72 % ) 5 ( < 1 % ) 25 (3 % ) 92 (10 % ) 133 (15 % )

* P < 0.05 * P =0.01 * P < 0.05 P =0.22 P =0.13

*Statistically signifi cant.

© 2009 by the American College of Gastroenterology The American Journal of GASTROENTEROLOGY

Abstracts S39

10-43; 22, 7-44; 29, 14-54 for novice readers 1 and 2, intermediate, and expert readers respectively. Compared to the expert reader, novice readers 1 and 2 agreed 80% and 88%, respectively (kappa=0.6, 0.7). Th e agreement for the inter-mediate reader was 84% (kappa=0.7). Th ere was no diff erence in the overall distribution of positive or negative SI/SAP results when comparing readers 1-3 to the expert (SI; p=0.5, 0.4, 0.1 and SAP; p=1, 0.9, 0.7). Th ere was a statistically greater number of negative SI/SAP results for all readers (p=0.03). Th e median read times for readers 1-3 were 2730 sec, 720 sec, and 360 sec.Conclusion: Th e number of refl ux episodes detected by expert analysis was signifi cantly diff erent than less experienced readers. Despite this diff erence in accuracy, the SI and SAP results did not appear aff ected as the number of positive or negative results for readers 1-3 were similar to the expert. A reading time for the expert was not measured because of teaching time devoted during expert reading sessions; however, the reading time was signifi cantly shorter for the intermediate reader compared to the novice readers.Disclosure: Dr Castell - Consultant: Sandhill Scientifi c.

96

Everyone Deserves a Second Chance: Validation of a Double LESP Profi le TechniqueJason Roberts, MD, Janice Freeman, BSN, Donald Castell, MD, FACG. Medical University of South Carolina, Charleston, SC.

Purpose: Traditional measurement of resting lower esophageal sphincter pres-sure (LESP) is obtained by slow withdrawal of pressure transducers across the LES at the beginning of the study. Patients are asked to refrain from swallowing during the pull through so that an average pressure can be calculated without the artifact of a relaxation and peristaltic wave. Oft en, patients do swallow mak-ing it diffi cult to measure a high pressure zone during quiet respirations. Aim: Th is present study evaluated the feasibility of obtaining a resting LESP at the conclusion of the manometry study as compared to the beginning.Methods: We analyzed 100 manometry tracings performed at the Esophageal Laboratory at the Medical University of South Carolina from January 2008 to July 2008. Th e tracings were selected in random fashion from our database of esophageal manometry (EM) studies. Esophageal function testing (EFT) was

performed with a Koenigsberg 9-channel probe (Sandhill EFT catheter, Sand-hill Scientifi c, Inc, Highlands Ranch, CO). Th e EFT catheter was passed trans-nasally into the stomach to a depth of 60 cm. two circumferential transducers spaced 5 cm apart at the distal end of the catheter were used to identify the lower esophageal sphincter (LES) using a station pull-through technique. Th e proximal transducer is slowly pulled across the LES and the distal one is left in the high pressure zone during the full study. Aft er all swallows were completed, the distal transducer in the HPZ was pulled across the LES using the station pull-through technique.Results: A total of 200 LES profi les were analyzed in 100 patients. Th e mean LESP was 31.7 mmHg±1.8 for the initial pull through and 29.6 mmHg±1.7 for the second (p=0.12) with ranges of 6-101 mmHg and 5-93 mmHg, respec-tively. Th e Pearson’s correlation coeffi cient was 0.71 (r 2=0.51). Th e slope of the regression line was 0.88 with the y intercept at 0 (Figure 1).Conclusion: An LES pull through at the end of the manometric study reliably confi rms the initial value. Th e strong correlation indicates that either profi le can be used to report resting LESP.Disclosure: Dr Castell - Consultant: Sandhill Scientifi c.

97

Baseline Intraluminal Impedance in the Distal Esophagus Does Not Predict Intercellular Space DistanceJason Roberts, MD, Brandon Craft , MD, Janice Freeman, MD, Debra Hazen-Martin, PhD, Marcelo Vela, MD, FACG. Medical University of South Carolina, Charleston, SC.

Purpose: Background: Esophageal distal baseline impedance (DBI) measured during multichannel intraluminal impedance (MII) is decreased in patients with major motility abnormalities. Th e mechanism for this is not clear but fl uid retention in the distal esophagus or increased conductance across the esophageal epithelium may explain the lowered impedance. Dilation of the intercellular space distance (ISD) measured by electron microscopy is a reli-able morphometric marker of increased epithelial permeability. Changes in transepithelial impedance have been shown to be associated with dilation of ISD in esophageal mucosa injured by acid and pepsin. It is not clear if a low DBI measured through MII correlates with increased ISD. Aim: Determine whether distal impedance measured through MII correlates with the intercellular space distance assessed by transmission electron micros-copy of esophageal biopsies.Methods: Healthy volunteers (HV) and patients with heartburn refractory to twice daily PPI underwent impedance-manometry (MII-EM), 24-hr MII-pH, and upper endoscopy with biopsies taken 5 cm above the esophagogastric junction for analysis by electron microscopy. Patients with esophagitis on EGD or abnormal MII-pH defi ned by increased distal esophageal acid exposure or a positive symptom index (>50% symptom events associated with a refl ux episode) were classifi ed as GERD. Patients with normal EGD and MII-pH were classifi ed as functional heartburn (FH). To determine ISD, 10 discrete measurements were made between adjacent cells in 10 micrographs (5,000� magnifi cation) per patient, using computer-assisted morphometry (Image J soft ware). Th e mean ISD was the average of these 100 measurements. MII-EM was assessed to determine the pre-swallow DBI at 5 cm above the LES during a quiescent period during which there was no swallowing. A DBI > 1,000 ohms was considered normal.

Inter-observer characteristics and symptom refl ux associations

Reader 1 Reader 2 Reader 3 Expert

Total number of refl ux episodes †

38 25 22 29

( + / − ) SI ‡ 42 / 48 29 / 60 25 / 65 36 / 54

( + / − ) SAP ‡ 27 / 63 23 / 67 28 / 62 26 / 64

SI agreement (kappa)

0.60 0.74 0.66 1

SAP agreement (kappa)

0.60 0.64 0.63 1

Reading time (seconds) †

2730 720 360 —

† (p < 0.05); ‡ (p>0.05) .

[97]

Number of patients Mean age Mean DBI

(ohms) P vs. HV P vs. FH Mean ISD ( ì m) P vs. HV P vs. FH

Healthy Volunteers (HV)

10 39 2559 — 0.26 0.27 — 0.053

Functional Heartburn (FH)

10 47 1951 0.26 — 0.38 0.053 —

GERD 14 46 1917 0.19 0.97 0.83 0.007 0.03

The American Journal of GASTROENTEROLOGY VOLUME 104 | SUPPLEMENT 3 | OCTOBER 2009 www.amjgastro.com

AbstractsS40

Results: 10 healthy volunteers, 10 FH, and 14 GERD patients were included. Demographics, mean ISD and mean DBI for each group shown in the Table. Upper limit of normal ISD was 0.68 μm, defi ned by the 95th percentile ISD in HV. Th ere was no correlation between ISD and DBI by Spearman coeffi cient (r=�0.33, r2=0.08; p=0.07). Assessment in only those patients with increased ISD (>0.68 μm) also showed lack of correlation between ISD and DBI (r=�0.32, r2=�11; p=0.5). Chi square test showed no intervariable dependence for nor-mal/abnormal ISD and normal/abnormal DBI.Conclusion: Esophageal DBI measured by MII at 5 cm above the LES does not correlate with ISD determined by electron microscopy of esophageal biopsies from t the same location. A low DBI measured using MII is not a reliable indi-cator of increased ISD.

STOMACH

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Sensitivity of Gastric Biopsy and Stool Antigen for H. pylori DiagnosisGregg Valenzuela, MD, Donna Dickinson, RN. Riverside Health System, Tappahannock, VA.

Purpose: Helicobacter pylori (HP) poses a signifi cant risk for development of gastric carcinoma, for risk of bleeding with NSAIDS (nonsteroidal anti-infl am-matory drugs) and for the occurrence of peptic ulcer disease. Gastric biopsy for detecting urease activity is frequently used for diagnosis of infection with Heli-cobacter pylori. We compared the sensitivity of gastric biopsies tested for urease (CLO)(CLOtest, Tri-Med Specialties Inc. Lenexa, KS) and stool Helicobacter pylori antigen (HP-AG) obtained by stool aspirate (Mayo Medical Laboratories, Rochester MN, ELISA with a plurality of monoclonal HP antibodies).Methods: 100 consecutive patients requiring upper and lower endoscopy for diagnoses of dyspepsia and gastrointestinal bleeding had 2 biopsies of the antrum and greater curve submitted for CLO testing and stool aspirates sent for HP-AG.Results: Th ere were assumed to be no False Positive results. A total of 26/100 patients were positive for either CLO or HP-AG. Six were positive only for CLO; 14 were postive only for HP_AG; 6 were positive for both. For CLO test-ing, the results were: CLO RESULTS: True Positive 12 False Positive 0 False negative 14 True negative 74 CLO sensitivity was 46%; HP_AG sensitivity was 77%. Th e false negative rate for CLO was 54%. Th e negative predictive value for CLO was 84%, for HP_AG was 92%.Conclusion: Discussion: CLO testing has a low sensitivity compared to HP_AG, but a single HP-AG by stool aspirate itself missed 23% of positive patients. In patients where it is important to know the Helicobacter pylori sta-tus, doing both tests by stool aspirate at the time of colonoscopy or by sending a separate stool sample, provides a better sensitivity and is much better than CLO testing alone which missed the diagnosis in over half of the patients.

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Long Term Proton Pump Inhibitor Th erapy and its Association with Fundic Gastric PolypsKireet Agrawal, MBBS,1 Viplove Senadhi, MD,2 Sudhir Dutta, MD, FACP3. 1. Division of Gastroenterology, Department of Medicine, Sinai Hospital/Johns Hopkins School of Medicine/John H. Stroger, Jr. Hospital of Cook County., Baltimore, MD; 2. Division of Gastroenterology, Department of Medicine, Sinai Hospital/Johns Hopkins School of Medicine, Baltimore, MD; 3. Division of Gastroenterology, Department of Medicine, Sinai Hospital/Johns Hopkins School of Medicine and University of Maryland School of Medicine, Baltimore, MD.

Purpose: Proton pump inhibitors (PPI) have been eff ectively used to treat acid peptic disease for a few decades now. Recent studies have associated long term PPI use with osteoporosis, increased incidence of Clostridium diffi cile colitis, Vitamin B12 defi ciency and more recently with development of Fundic Gastric Polyps (FGPs). Th e association of PPIs with FGPs continues to be controversial and poorly understood. Th e purpose of this study was to present in detail a series of three cases that developed FGPs with long term PPI therapy and had complete resolution aft er discontinuation of the PPI.

Methods: In this longitudinal study, three patients (average 57 years; range 52 to 66 years) with documented Gastroesophageal Refl ux Disease (GERD) with long term PPI therapy (average 9 years; range 6 to 13 years) were included. Each patient had well documented endoscopy with mucosal biopsies prior to PPI ther-apy, during and following discontinuation of PPI therapy. Helicobacter pylori testing was performed on the mucosal biopsies using standard techniques.Results: No polyps were observed in the body of the stomach in all three cases prior to PPI therapy. Aft er long term PPI therapy (6 to 12 years), a follow-up endoscopy performed to evaluate persistent GERD symptoms revealed pres-ence of multiple sessile polyps. At this point of time, association of FGPs with PPI use was considered and therefore PPI therapy was discontinued. Repeat endoscopies 1 to 2 years aft er discontinuation of PPI therapy revealed near complete disappearance of these FGPs in all three cases. All three cases were negative for Helicobacter pylori infection.Conclusion: Th ese observations suggest that long term use of PPI therapy in a select group of patients may be associated with development of numerous fundic polyps in the stomach. Th is phenomenon seems to be reversible with discontinuation of PPI therapy.

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Association of H. pylori with Iron Defi ciency Anemia: Myth or Reality?Rizwan Kibria, MD,1 Khurram Bari, MD,1 Qasim Khalil, MD,1 Kanan Sharma, MD,1 Muhammad Beg, MD,2 Salma Akram, MD, FACG,1 Syed Ali, MD, FACG1. 1. Gastroenterology, Wright State University SOM, Dayton, OH; 2. University of Cincinnati, Cincinnati, OH.

Purpose: Clinical and epidemiological studies suggest that infection with H. Pylori is associated with iron defi ciency. Whether routine gastric biopsies should be performed for H. pylori in patients undergoing upper GI endoscopy with iron-defi ciency still remains controversial.Methods: A retrospective review of Dayton VA Medical Center patients who underwent endoscopic evaluation for iron defi ciency between January 2005-December 2007 was performed. Exclusion criteria included: 1) Recent acute GI hemorrhage; 2) Upper and lower endoscopy fi ndings expalining iron defi e-icncy anemia; 3) Other conditions that could justify microcytic anemia as thal-assemia or malignancy.Results: Out of a total 413 EGDs, gastric biopsies were obtained in 109 (26%) cases. Biopsies were positive for H. pylori in 21 (19%) cases. 102 out of total 109 patients (93%) were males. Age at the time of EGD was 66 and 65 years amongst patients with H. pylori negative and positive biopsy, respectively. Age at time of EGD, time from diagnosis of anemia to EGD, MCV and iron saturation were not statistically diff erent between the 2 groups. Patients with H. pylori positivity were more likely to be B12 defi cient (6% vs. 24%; p-value 0.02). Aspirin use and PPI therapy were more common amongst patients who were H. pylori negative (14% vs. 42%; p-value 0.02; 19% vs. 55 %; p-value 0.04).Conclusion: Th e prevalence of H. pylori in our cohort was lower than general population. We could not demonstrate a clear association between presence of H. pylori and iron defi ciency anemia. Further studies are needed to accept or refute this idea.

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Comparison Between Oral vs. Intravenous Administration of PPI with Gastric pHJin Il Kim, MD, PhD,1 Dae Young Cheung, MD, PhD,1 Se Hyun Cho, MD, PhD,1 Hwoon Yong Jung, MD, PhD,2 Jae Gyu Kim, MD, PhD,3 Jae Jun Kim, MD, PhD,4 Sang Woo Lee, MD, PhD5. 1. Th e Catholic University of Korea, Seoul, Korea, South; 2. University of Ulsan College of Medicine, Seoul, Korea, South; 3. Chung-Ang University School of Medicine, Seoul, Korea, South; 4. Sungkyunkwan University School of Medicine, Seoul, Korea, South; 5. Korea University College of Medicine, Seoul, Korea, South.

Purpose: In patients with peptic ulcer bleeding, a proton pump inhibitor (PPI) is administered intravenously (IV) following endoscopic treatment. However, if oral administration (PO) of the PPI obtains the same antisecretory eff ect as IV administration of the PPI (IV PPI), PO PPI treatment will be more