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2010 25: 658Nutr Clin PractKrishdeep Singh Chadha, Chandana Thatikonda, Michael Schiff, Hector Nava and Michael D. Sitrin

Device in Head and Neck and Esophageal Cancer PatientsOutcomes of Percutaneous Endoscopic Gastrostomy Tube Placement Using a T-Fastener Gastropexy

  

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658

Nutrition in Clinical PracticeVolume 25 Number 6

December 2010 658-662© 2010 American Society for

Parenteral and Enteral Nutrition10.1177/0884533610385350

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Cancers of the head and neck account for 5% of all new cancers in the United States with an annual incidence of approximately 45,000 cases.1

The incidence of esophageal cancer has been increasing with about 16,400 estimated newly diagnosed cases in 2008.1 Patients with head, neck, and esophageal cancers

From the 1Department of Medicine, State University of New York at Buffalo, Buffalo, New York; the 2Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York; and the 3Department of Surgery, Roswell Park Cancer Institute, Buffalo, New York.

Address correspondence to: Michael D. Sitrin, Division of Gastroenterology, Hepatology and Nutrition, State University of New York at Buffalo, ECMC, 462 Grider Street, Buffalo, NY 14215; e-mail: dpnish62@gmail.com.

frequently present with or will develop dysphagia during the course of their treatment.

Percutaneous endoscopic gastrostomy (PEG) tube placement is frequently used in these patients to improve nutrition status, avoid dehydration, and improve quality of life. Retrospective studies have suggested that early PEG placement at the beginning of chemo-radiation in patients with head and neck tumors maintains their nutrition state and reduces treatment interruptions.2 Studies have found complication rates with PEG tube placement, mostly infec-tious, to be higher in patients with head and neck cancers than in other subsets of patients.3,4 This could be related to the patient’s underlying malnutrition and immune-sup-pression. There is increased risk of tumor-associated bleed-ing and mechanical difficulty encountered in PEG placement with the use of the conventional pull technique

Background: Percutaneous endoscopic gastrostomy (PEG) tube placement by the pull technique in head, neck, and esophageal cancer patients has a high complication rate, particularly in infections, and a small risk of tumor implantation. The T-fastener gastropexy technique uses a transabdominal approach to place the PEG device. Objectives: The objective of this study was to review the clinical outcomes and complica-tions related to endoscopic PEG placement with the T-fastener gastropexy technique in patients with head, neck, and esopha-geal cancers. Methods: This study was a retrospective review of all patients with head, neck, and esophageal cancers with PEG placement from January 1998 to June 2008. Clinical data including patient’s age, gender, type and stage of cancer, date of PEG placement and removal, and reason for PEG removal was recorded. Results: The study group consisted of a total of 356 patients of which 244 were male and 112 were female with a mean age of 63.3 years. There were 276 patients with

head and neck cancer, 75 patients with esophageal cancer, and 5 with gastro-esophageal junction cancer. Staging data was available for 326 patients of which 56 (17.1%) had early stage disease (stage 1 and 2) and 270 patients (82.9%) had late stage (3 and 4) disease. None of these patients received antibiotic prophylaxis prior to PEG placement. Cellulitis around the PEG site occurred in 8.4% of cases and an abscess in 3.7% of cases. Only 4 (1.2%) infectious complications were within the first 30 days of PEG placement, and there were no intraopera-tive deaths or cases of tumor implantation. Conclusions: In the authors’ experience, the T-fastener gastropexy technique for PEG placement in head, neck, and esophageal cancer patients carried a low overall complication rate and compared favorably with the results of pull method reported in the literature. (Nutr Clin Pract. 2010;25:658-662)

Keywords: enteral nutrition; gastrostomy

Outcomes of Percutaneous Endoscopic Gastrostomy Tube Placement Using a T-Fastener Gastropexy Device in Head and Neck and Esophageal Cancer Patients

Krishdeep Singh Chadha, MD1; Chandana Thatikonda, MBBS1; Michael Schiff, MD2; Hector Nava, MD3; and Michael D. Sitrin, MD1

Financial disclosure: none declared.

Clinical Research

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because of upper aero-digestive tract obstruction by the tumor.5 There is data showing a small but definite risk of tumor seeding of the PEG site with the use of the pull technique in upper aero-digestive tumors.

In the introducer technique, the gastrostomy tube is introduced by means of percutaneous puncture, avoiding passage through the mouth and any tube contamination by upper aero-digestive organisms or tumor cells. It can be performed under either radiological or endoscopic guidance.6,7 The T-fastener gastropexy technique described by Brown and Muller is a variant of the intro-ducer technique using T-fasteners to place the PEG device.8,9 At Roswell Park Cancer Institute (RPCI), endo-scopic PEG placement using this technique has been used exclusively for head, neck, and esophageal cancer patients. The objective of the study was to review the clinical outcomes and complications related to PEG placement using the T-fastener gastropexy device in patients with head, neck, and esophageal cancers.

Methods

This study was a retrospective study of all patients with head, neck, and esophageal cancers undergoing PEG placement with the T-fastener gastropexy device over a period of 10 years from January 1998 to June 2008. A total of 356 patients were included in the study. All PEG procedures were performed by multiple physicians at RPCI in an endoscopy suite or operating room. Clinical data including patient’s age, gender, type and stage of cancer, and survival were recorded. Complete staging data were available on 326 patients. Peg-related compli-cations, removals (if done), and reasons for PEG removal were noted.

In RPCI, the technique described by Brown and Muller is used for PEG placement.9 First, the T-fasteners are loaded on the introducer needle and are placed under endoscopic guidance through the anterior abdominal wall, pulling the stomach up against the abdominal wall. About 4 T-fasteners are placed circumferentially over the anterior abdominal wall. The site for the actual PEG placement lies in the center of the T-fasteners. A 1-cm horizontal incision is made at the identified site of PEG placement and a guidewire is introduced into the stom-ach with help of a cannula. The cannula is removed and the tract is then serially dilated with the help of dilators, which are introduced over the guidewire. The gastros-tomy tube is then placed over the guidewire, through the abdomen, and into the stomach, then secured with the help of sutures. The entire procedure is done under endo-scopic visualization and the gastrotomy tube bypasses the upper aero-digestive tract completely by this technique. Like all other PEG procedures, this can be done under conscious sedation. No systemic antibiotics are used for

perioperative prophylaxis of PEG-related infections and postprocedure skin care is same as with other PEG place-ments, including use of an antibiotic ointment. The T-fasteners remain in place for 2 weeks and are then removed.

Statistical Analysis

Categorical patient characteristics (eg, gender) were sum-marized as proportions with exact 95% confidence inter-vals (CI). Fisher’s exact test was used to compare the complication rates among patient subgroups. Continuous variables (eg, age) were summarized by using the mean (standard deviation [SD]) and median (range).

Logistic regression was used to evaluate univariate associations between continuous predictors and the inci-dence of major complications, as well as to construct multivariable predictor models for complication rates.

Results

Patient Characteristics

The study group consisted of a total of 356 patients of which 244 were males and 112 were females with mean age of 63.25 years. There were 276 patients with head and neck cancer, 75 patients had esophageal cancer, and 5 had gastro-esophageal junction cancer. The staging data was available for 326 patients of which 56 (17.1%) had early stage disease (stage 1 and 2) and 270 patients (82.9%) had late stage (stage 3 and 4) disease. Table 1 summarizes the patient characteristics.

Complications

The most common complications reported were minor complications related to discomfort and skin excoriations around the PEG site. Cellulitis was the most common major complication accounting for 30 (8.6%) patients and abscess at the PEG site was seen in 13 (4%) patients. One patient developed a splenic abscess, more than 30 days postprocedure, which was treated with intravenous anti-biotics. Minor bleeding, which spontaneously stopped, was reported in 13 (4%) patients. There were no intraop-erative deaths related to PEG placement. No cases of tumor implantation at the PEG site were identified. If the patients underwent premature PEG tube removal and replacement, it was mostly because of leakage (n = 30) and accidental dislodgement (n = 10). One patient under-went PEG removal for abscess and the other because of discomfort around the PEG site. The various complica-tions associated with premature PEG placement and reasons for PEG removal are summarized in Table 2. There were no differences in various complication rates

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related to the site of cancer, type of cancer, stage, or other patient characteristics using logistic regression with mul-tivariable predictor models.

Discussion

In cancers of the upper aero-digestive tract, PEG tubes are often used for nutrition support. The pull method was the first technique used for PEG placement and is still the most widely used.10 When this method is used in patients with head and neck malignancies, the overall reported complication rate is 20% to 50% with a mortality rate of 5%.11-14 Most of these complications occur as a result of PEG site infection. In the pull technique, the gastrostomy catheter passes through the mouth, pharynx, and esophagus before reaching in the abdominal wall. This is likely to transport oropharyngeal organisms to the PEG stoma in the abdominal wall, thereby increasing the risk of early PEG site infections. This is the rationale for using prophylactic antibiotics prior to the procedure,15,16 particularly in cancer patients who are prone to peristo-mal infection.17,18 In a small prospective study of 28 patients with head and neck cancers, the PEG site infec-tion rate was noted to be 36% with the pull method even with antibiotic prophylaxis.19 The same bacteria cultured from the oropharynx were also isolated from the PEG site infection.

Retrospective studies with the introducer technique showed a low risk of peristomal infection and complica-tions.7,20 A small number of nonrandomized prospective studies comparing the pull technique with the introducer technique have shown that the latter was associated with lower risk of peristomal infection and aspiration pneumo-nia and shorter postoperative hospital stay.21-23 A lower risk of infection and tumor implantation has motivated several authors to adopt the introducer method instead of the pull technique for PEG placement.24,25

The introducer technique bypasses the oropharyngeal mucosa and results in no contamination of PEG site by oral flora; therefore, no antibiotic prophylaxis is thought to be required. The Brown Mullen introducer technique involves fixation of the anterior gastric wall to the abdom-inal wall with the help of 4 T-fasteners (gastropexy) and then placing the PEG tube transabdominally. At RPCI, no prophylactic systemic antibiotics were used for endo-scopic PEG placement with the Brown Muller introducer technique. We have previously reported the use of this technique on 148 head and neck cancer patients from 1999-2003.9 In this current study, we have accepted addi-tional head and neck cancer patients updating our data

Table 1. Clinical Characteristics of Patients With Head, Neck, and Esophageal Cancer

Undergoing PEG Placement Using the Brown Muller Introducer Technique

Patient age in years Mean = 63.2Gender Male = 244

Female = 112Tumor stage N = 326Early (1, 2) 56 (17.1%)Late (3, 4) 270 (82.9%)Cancer location Esophagus 75 (21.0%) Tongue 58 (16.3%) Larynx 54 (15.1%) Tonsil 34 (9.5%) Floor of mouth 32 (8.9%) Oropharynx 14 (3.9%) Mouth 13 (3.8%) Neck 9 (2.5%) Piriform 9 (2.5%) GE junction 5 (1.4%) Othersa 53 (14.9%) GE; gastroesophageal; PEG, percutaneous endoscopic gas-trostomy.aOthers in the table included soft palate, hard palate, hypophar-ynx, and multiple site involvement.

Table 2. Complications of PEG Placement and Reasons for Premature PEG Removal

ComplicationsNumber of

PatientsPercentage of

Patients

Infectious Complicationsa

Abscess 13 3.7 Cellulitis 30 8.4Infectious complications within 30 days

4 1.2

Bleedingb 13 3.7Discomfort around PEG site 52 14.6Skin excoriations around PEG site

63 17.7

Mechanical complications Dislodgement 35 9.8 Migration 7 2.0Technical issues PEG tube leakage 30 8.4 Obstructed PEG tube 14 3.9Reasons for premature PEG removal Dislodgement 10 3.0 Leakage 30 8.4 Discomfort 1 0.3 Abscess 1 0.3

PEG, percutaneous endoscopic gastrostomy.aOnly 3 cases of cellulitis and 1 case of abscess were noted within 30 days of PEG placement.bAll cases were self-limiting and stopped simultaneously. None of the cases required endoscopic intervention.

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through 2008; we also included our experience with esophageal and gastro-esophageal junction cancer patients. Our PEG site infection rate in this study was noted to be about 12%, which is slightly higher than reported for PEG placement in general, but less than the reported data on head and neck cancer patients.11-14 There was only 1 case of PEG site abscess and 3 patients developed cellulitis within 30 days of PEG placement. All other infections occurred after 30 days of PEG placement and would not have been prevented by periprocedure antibiotic prophylaxis. In a recent multicenter prospective study of 97 patients from Europe who underwent PEG placement by the introducer technique, there was no dif-ference in infection rates at 7 days post-PEG follow-up when preprocedure antibiotics were used.26 A potential drawback with our retrospective review is that infectious complications like cellulitis may be overstated as there is a low threshold of using antibiotics in already immune-suppressed patients. Multivariate analyses did not find any difference in complication rates between head, neck, and esophageal cancer patients.

In a large study of 435 patients presenting with malignant neoplasia and undergoing PEG placement by a variant of the introducer technique using stitches, there were 12 reported complications (2.8%) with 2 cases of pneumoperitoneum that required laparotomy. One patient developed a gastro-cutaneous fistula, 1 patient had peris-tomal infection, and there was 1 death related to the procedure.27 In our study using T-fasteners, there were fewer major complications and no deaths or complica-tions requiring surgery.

Tumor seeding or metastasis at the PEG site is a rare complication (1%) with the pull method. The median time to development of this complication is approximately 8 months post-PEG placement and leads to loss of a curable patient.28 In a recent meta-analysis of 44 peristomal metastases, PEG site implantation has been commonly associated with less well-differentiated tumors and usually squamous carcinomas.29 Therapeutic risk factors for stomal metastases included the follow-ing: endoscopic PEG placement, pull-string PEG tech-nique, untreated primary cancer, or known local recurrence after treatment before PEG. Although hematogenous spread is possible, the mechanism of implantation is thought to be most likely a direct seed-ing of the tumor as the PEG tube shears off cells dur-ing placement.30,31 In a recent study of 218 patients with head and neck cancer who had PEG placement by pull technique, 2 patients were noted to have PEG site metastases.32 When upper aero-digestive cancers metastasize to the PEG site, the patient survival is lim-ited even after extensive resection. Hence, the intro-ducer method, which bypasses the tumor site, would be potentially advantageous in this group of patients.

To summarize, PEG placement in patients with upper aero-digestive cancers carries a high risk of complications, mostly infectious. There is also a small but definite risk of PEG site metastases. Our experience with the Brown Muller T-fastener introducer technique has been favora-ble, with fewer infectious complications and PEG site metastases than reported in the literature for the pull technique or other introducer methods. Further prospec-tive studies directly comparing various PEG placement techniques in patients with upper aero-digestive malig-nancies are needed to definitively define the optimal method.

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28. Schneider AM, Loggie BW. Metastatic head and neck cancer to the PEG exit site: a case report and review of the literature. Am Surg. 1997;63:481-486.

29. Cappell MS. Risk factors and risk reduction of malignant seeding of the percutaneous endoscopic gastrostomy track from pharyn-goesophageal malignancy: a review of all 44 known reported cases. Am J Gastroenterol. 2007;102:1307-1311.

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