1
650 Use of Hemostatic Clips in Patients Undergoing Colonoscopy in the Setting of Coumadin Anticoagulation Therapy Douglas A. Howell, Sheila L. Eswaran, Burr J. Loew, Michael K. Sanders, John F. Erkkinen, Kirk P. Bernadino, Bejamin B. Potter, Gordon A. Millspaugh, James H. Morse, Michael A. Roy, Andreas M. Stefan, Karl C. Sze, Janice M. Campana Background: Coumadin anticoagulation (CAC) presents a significant dilemma in the performance of colonoscopy. ASGE guidelines have suggested management options, but no consensus exists regarding resumption of CAC which increases the risk of post-polypectomy hemorrhage by 5 fold (GIE 2004;59:44). Definitive hemostasis at the time of polypectomy might permit minimal or no interruption of CAC. An IRB approved, multi-departmental, prospective study is presented. Patients and Methods: Patients (pts) on CAC referred for colonoscopy were identified as low- risk or high-risk for interruption of CAC by ASGE criteria. Low-risk pts held CAC 4 days; high-risk held CAC for only 48 hours, with no heparin initiated. During colonoscopy, all polypectomy sites larger than forceps biopsies were treated with either hemostatic clips (Tri Clip (Cook Medical), QuickClip (Olympus), Resolution Clip (Microvasive)) or Endoloops (Olympus). Definitive hemostasis was judged as ideal, satisfactory, or unsatisfactory. Resumption of CAC depended on the success of hemostasis. The option of post-polypectomy heparin therapy was considered on an individual basis. Follow-up was by telephone at 1, 7 and 30 days. Results: 71 (M Z 44, F Z 27) pts (low-risk n Z 53, high-risk n Z 18) enrolled from 02/05-11/05. 45/71 pts had polyps (29/45 (64%) had at least 1 adenoma). Total number of polyps removed: n Z 105 (mean Z 2.3, median Z 2, range 1 to 10). Total number of clips used: n Z 111 (QuickClip n Z 54, Resolution Clip n Z 30, Tri Clip n Z 27), Endoloop n Z 2. Mean number of hemostatic device per polyp was 1.1 and per patient was 2.5. Definitive hemostasis was judged to be ideal or satisfactory in 44/45 (98%) and unsatisfactory 1/45 (2%). Mean INR values at the time of procedure: low-risk pts 1.4 (range 1.1 - 2.8), high-risk pts 1.6 (range 1.1 - 2.6). CAC was immediately resumed in 65 of 71 pts (92%). 6 pts had a delay in resuming coumadin for 2 to 4 days due to the removal of large sessile polyps or physician preference. In follow-up, there was 1 case of a moderate LGIB reported at post-procedure day 21. No pts were hospitalized for heparin or experienced a thromboembolism. Conclusions: Patients receiving coumadin can safely undergo colonoscopy with or without polypectomy, by brief interruption of Rx and employing definitive mechanical hemostasis if polypectomy is needed. Immediate re-anticoagulation can generally be advised without a significant risk of delayed post-polypectomy bleeding. Favorable results were noted in both the low-risk (4 day hold) and high-risk (2 day hold) groups. Reimbursement to cover the costs of clips should be provided by third-party payers. 714 Is Variable Stiffness Colonoscope Better Than Regular Adult Colonoscope for Colonoscopy? Meta-Analysis of Randomized Controlled Trials. Mohamed O. Othman, Angela G. Bradley, Praveen K. Roy Introduction: Variable Stiffness Colonoscope (VSC) is believed to have theoretical advantages over the standard adult colonoscope (C). There are conflicting data regarding the usefulness of VSC. We conducted a meta-analysis to compare the efficacy of VSC with C. Methods: MEDLINE (from 1966-2005) and abstracts of gastroenterology scientific meetings in the last 5 years were searched (search date November 2005). Only randomized clinical trials (RCTs) conducted in adult subjects were included. We performed a meta-analysis with fixed effects model to compare cecal intubation rate, cecal intubation time abdominal pain scores and use of ancillary maneuvers. Separate analyses were performed for each main outcome by using weight mean difference (WMD) or odds ratio (OR) depending on the nature of the outcome. Results: Six RCTs satisfied the inclusion criteria with a total of 1092 patients. Three RCTs compared adult VSC to C, while the other three trials evaluated pediatric VSC. There was no significant heterogeneity among the studies. All studies evaluated VSC among experienced colonoscopists, while, one study evaluated VSC among inexperienced colonoscopists. Cecal intubation time was similar between the VSC and C groups (WMD Z 0.00, CI Z -0.68 to 0.69). Furthermore, subgroup analysis of RCTs with pediatric VSC also did not show any difference in cecal intubation time between pediatric VSC and C (WMD Z 0.13, CI Z -0.62 to 0.88). However, cecal intubation rate was higher with the use of VSC (OR Z 1.88, CI Z 1.10- 3.24). Compared to C, VSC was associated with less abdominal pain (SMD Z -0.23, CI Z -0.41 to 0.06) and decreased need for ancilliary maneuvers during colonoscopy. Conclusion: VSC does not appear to offer any distinct advantage over standard adult colonoscopes for routine colonoscopy. Further studies are needed to identify subgroups of patients that may benefit from the variable stiffness technology. 715 The Cost Effectiveness of Colonic Stenting As a Bridge to Curative Surgery in Patients with Acute Left-Sided Malignant Colonic Obstruction: A Canadian Perspective Harminder Singh, Laura E. Targownik, Steven Latosinsky, Brennan M. Spiegel Acute colonic obstruction will develop in up to one-third of patients with colon cancer. Traditionally, patients with acute colonic obstruction require emergency surgery for creation of a diverting colostomy, followed by surgical resection of the tumour if there is no evidence of metastatic disease. Over the last several years, colonic stents has also been proven to be efficacious for relieving malignant obstruction in both the palliative setting and as a bridge to surgical resection. The aim of this study was to determine the most cost-effective strategy for patients with acute malignant left-sided colonic obstruction in a Canadian setting. Methods: We developed a decision analytical model to calculate the cost-effectiveness of three competing strategies: 1) emergent colonic stenting (CS) followed by elective surgical resection and reanastomosis, 2) emergent resective surgery (RS) followed by creation of either a diverting colostomy or primary reanastomosis, 3) emergent diverting colostomy (DC) followed by elective surgical resection and reanastomosis. The costs were estimated from the perspective of Manitoba’s provincial health plan. Clinical outcomes evaluated included the proportion of patients requiring a permanent or temporary stoma, the total number of operations required by a patient, and overallmortality. Results: The use of CS results in fewer total operative procedures per patient (mean operations 1.03 vs. 1.32 with RS and 1.9 with DC), a lower mortality rate (5% vs. 11% with RS and 13% with DC) and a lower likelihood of requiring a permanent stoma (7% vs. 14% with RS as well as DC). CS is slightly more expensive than DC, but less costly than RS (11,851 with DC vs. $13,164 for CS vs. $13,820 with RS). The incremental cost effectiveness ratio (ICER) associated with the use of CS vs. DC is $1,415 to prevent a temporary stoma, $1,516 to prevent an additional operation, and $15,734 to prevent an additional death. Conclusions: Colonic stenting for patients with acute colonic obstruction secondary to a resectable colonic tumor is comparable in cost to surgical options and reduces the likelihood of requiring both temporary and permanent stomas, and may also be associted with lower procedure related mortality. Colonic stenting should be offered as the initial therapeutic modality for Canadian colorectal cancer patients presenting with acute obstruction as a bridge to definitive surgical resection. Cost per patient (\$CDN) Mean Operations per patient % requiring temp. stoma % requiring permanent stoma % mortality Emergency Colonic Stenting (CS) 13,164 1.03 7 2 5 Emergency Resective Surgery (RS) 13,820 1.32 44 14 11 Emergency Diverting Colostomy (DC) 11,851 1.90 100 14 13 Cecal intubation rate Cecal intubation time Abstracts www.giejournal.org Volume 63, No. 5 : 2006 GASTROINTESTINAL ENDOSCOPY AB99

The Cost Effectiveness of Colonic Stenting As a Bridge to Curative Surgery in Patients with Acute Left-Sided Malignant Colonic Obstruction: A Canadian Perspective

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Page 1: The Cost Effectiveness of Colonic Stenting As a Bridge to Curative Surgery in Patients with Acute Left-Sided Malignant Colonic Obstruction: A Canadian Perspective

650

Use of Hemostatic Clips in Patients Undergoing Colonoscopy

in the Setting of Coumadin Anticoagulation TherapyDouglas A. Howell, Sheila L. Eswaran, Burr J. Loew, Michael K. Sanders,John F. Erkkinen, Kirk P. Bernadino, Bejamin B. Potter,Gordon A. Millspaugh, James H. Morse, Michael A. Roy,Andreas M. Stefan, Karl C. Sze, Janice M. CampanaBackground: Coumadin anticoagulation (CAC) presents a significant dilemma in theperformance of colonoscopy. ASGE guidelines have suggested managementoptions, but no consensus exists regarding resumption of CAC which increases therisk of post-polypectomy hemorrhage by 5 fold (GIE 2004;59:44). Definitivehemostasis at the time of polypectomy might permit minimal or no interruption ofCAC. An IRB approved, multi-departmental, prospective study is presented. Patientsand Methods: Patients (pts) on CAC referred for colonoscopy were identified as low-risk or high-risk for interruption of CAC by ASGE criteria. Low-risk pts held CAC 4days; high-risk held CAC for only 48 hours, with no heparin initiated. Duringcolonoscopy, all polypectomy sites larger than forceps biopsies were treated witheither hemostatic clips (Tri Clip (Cook Medical), QuickClip (Olympus), ResolutionClip (Microvasive)) or Endoloops (Olympus). Definitive hemostasis was judged asideal, satisfactory, or unsatisfactory. Resumption of CAC depended on the success ofhemostasis. The option of post-polypectomy heparin therapy was considered on anindividual basis. Follow-up was by telephone at 1, 7 and 30 days. Results: 71 (M Z 44,F Z 27) pts (low-risk n Z 53, high-risk n Z 18) enrolled from 02/05-11/05. 45/71 ptshad polyps (29/45 (64%) had at least 1 adenoma). Total number of polyps removed:n Z 105 (mean Z 2.3, median Z 2, range 1 to 10). Total number of clips used: n Z111 (QuickClip n Z 54, Resolution Clip n Z 30, Tri Clip n Z 27), Endoloop n Z 2.Mean number of hemostatic device per polyp was 1.1 and per patient was 2.5.Definitive hemostasis was judged to be ideal or satisfactory in 44/45 (98%) andunsatisfactory 1/45 (2%). Mean INR values at the time of procedure: low-risk pts 1.4(range 1.1 - 2.8), high-risk pts 1.6 (range 1.1 - 2.6). CAC was immediately resumed in65 of 71 pts (92%). 6 pts had a delay in resuming coumadin for 2 to 4 days due to theremoval of large sessile polyps or physician preference. In follow-up, there was 1case of a moderate LGIB reported at post-procedure day 21. No pts werehospitalized for heparin or experienced a thromboembolism. Conclusions: Patientsreceiving coumadin can safely undergo colonoscopy with or without polypectomy,by brief interruption of Rx and employing definitive mechanical hemostasis ifpolypectomy is needed. Immediate re-anticoagulation can generally be advisedwithout a significant risk of delayed post-polypectomy bleeding. Favorable resultswere noted in both the low-risk (4 day hold) and high-risk (2 day hold) groups.Reimbursement to cover the costs of clips should be provided by third-party payers.

714

Is Variable Stiffness Colonoscope Better Than Regular Adult

Colonoscope for Colonoscopy? Meta-Analysis of Randomized

Controlled Trials.Mohamed O. Othman, Angela G. Bradley, Praveen K. RoyIntroduction: Variable Stiffness Colonoscope (VSC) is believed to have theoreticaladvantages over the standard adult colonoscope (C). There are conflicting dataregarding the usefulness of VSC. We conducted a meta-analysis to compare theefficacy of VSC with C. Methods: MEDLINE (from 1966-2005) and abstracts ofgastroenterology scientific meetings in the last 5 years were searched (search dateNovember 2005). Only randomized clinical trials (RCTs) conducted in adult subjectswere included. We performed a meta-analysis with fixed effects model to comparececal intubation rate, cecal intubation time abdominal pain scores and use ofancillary maneuvers. Separate analyses were performed for each main outcome byusing weight mean difference (WMD) or odds ratio (OR) depending on the natureof the outcome. Results: Six RCTs satisfied the inclusion criteria with a total of 1092patients. Three RCTs compared adult VSC to C, while the other three trialsevaluated pediatric VSC. There was no significant heterogeneity among the studies.All studies evaluated VSC among experienced colonoscopists, while, one studyevaluated VSC among inexperienced colonoscopists. Cecal intubation time wassimilar between the VSC and C groups (WMD Z 0.00, CI Z -0.68 to 0.69).Furthermore, subgroup analysis of RCTs with pediatric VSC also did not show anydifference in cecal intubation time between pediatric VSC and C (WMD Z 0.13,CI Z -0.62 to 0.88). However, cecal intubation rate was higher with the use of VSC(OR Z 1.88, CI Z 1.10- 3.24). Compared to C, VSC was associated with lessabdominal pain (SMD Z -0.23, CI Z -0.41 to 0.06) and decreased need for ancilliarymaneuvers during colonoscopy. Conclusion: VSC does not appear to offer anydistinct advantage over standard adult colonoscopes for routine colonoscopy.Further studies are needed to identify subgroups of patients that may benefit fromthe variable stiffness technology.

Cecal intubation rate

Cecal intubation time

Abstracts

www.giejournal.org

715

The Cost Effectiveness of Colonic Stenting As a Bridge

to Curative Surgery in Patients with Acute Left-Sided Malignant

Colonic Obstruction: A Canadian PerspectiveHarminder Singh, Laura E. Targownik, Steven Latosinsky,Brennan M. SpiegelAcute colonic obstruction will develop in up to one-third of patients with colon cancer.Traditionally, patients with acute colonic obstruction require emergency surgery forcreation of a diverting colostomy, followed by surgical resection of the tumour if thereis no evidence of metastatic disease. Over the last several years, colonic stents has alsobeen proven to be efficacious for relieving malignant obstruction in both the palliativesetting and as a bridge to surgical resection. The aim of this study was to determine themost cost-effective strategy for patients with acute malignant left-sided colonicobstruction in a Canadian setting. Methods: We developed a decision analytical modelto calculate the cost-effectiveness of three competing strategies: 1) emergent colonicstenting (CS) followed by elective surgical resection and reanastomosis, 2) emergentresective surgery (RS) followed by creation of either a diverting colostomy or primaryreanastomosis, 3) emergent diverting colostomy (DC) followed by elective surgicalresection and reanastomosis. The costs were estimated from the perspective ofManitoba’s provincial health plan. Clinical outcomes evaluated included theproportion of patients requiring a permanent or temporary stoma, the total number ofoperations required by a patient, and overall mortality. Results: The use of CS results infewer total operative procedures per patient (mean operations 1.03 vs. 1.32 with RSand 1.9 with DC), a lower mortality rate (5% vs. 11% with RS and 13% with DC) anda lower likelihood of requiring a permanent stoma (7% vs. 14% with RS as well as DC).CS is slightly more expensive than DC, but less costly than RS (11,851 with DC vs.$13,164 for CS vs. $13,820 with RS). The incremental cost effectiveness ratio (ICER)associated with the use of CS vs. DC is $1,415 to prevent a temporary stoma, $1,516 toprevent an additional operation, and $15,734 to prevent an additional death.Conclusions: Colonic stenting for patients with acute colonic obstruction secondaryto a resectable colonic tumor is comparable in cost to surgical options and reduces thelikelihood of requiring both temporary and permanent stomas, and may also beassocited with lower procedure related mortality. Colonic stenting should be offeredas the initial therapeutic modality for Canadian colorectal cancer patients presentingwith acute obstruction as a bridge to definitive surgical resection.

Cost perpatient(\$CDN)

MeanOperationsper patient

%requiringtemp.stoma

% requiringpermanentstoma

%mortality

EmergencyColonic Stenting(CS)

13,164 1.03 7 2 5

EmergencyResectiveSurgery (RS)

13,820 1.32 44 14 11

EmergencyDivertingColostomy (DC)

11,851 1.90 100 14 13

Volume 63, No. 5 : 2006 GASTROINTESTINAL ENDOSCOPY AB99