Elsevier

Gastrointestinal Endoscopy

Volume 59, Issue 2, February 2004, Pages 163-171
Gastrointestinal Endoscopy

Orginal Article
Endoscopic full-thickness plication for the treatment of GERD: a multicenter trial☆

https://doi.org/10.1016/S0016-5107(03)02542-2Get rights and content

Abstract

Background

A novel endoscopic full-thickness plication device has been designed to inhibit gastroesophageal reflux by placing a transmural plication near the gastroesophageal junction under direct endoscopic visualization. This study assessed the safety and efficacy of endoscopic full-thickness plication in the treatment of patients with symptoms caused by GERD.

Methods

Patients with chronic heartburn requiring maintenance therapy with antisecretory medication were recruited. Exclusion criteria were the following: hiatal hernia (>2 cm), grade III and IV esophagitis, and Barrett's esophagus. The following were assessed over a follow-up period of 6 months: GERD–Health-Related Quality of Life, Gastrointestinal Symptom Rating Scale, and SF-36 Health Survey, medication use, 24-hour esophageal pH monitoring and esophageal manometry. Patients underwent a single, full-thickness plication in the gastric cardia just distal to the gastroesophageal junction. Re-treatment was not permitted.

Results

A total of 64 patients (mean age 46.3 years, range 23-71 years) underwent endoscopic full-thickness plication (mean procedure time 17.2 minutes). At 6 months after plication, proton pump inhibitor therapy had been eliminated in 74% of previously medication-dependent patients. Median GERD–Health-Related Quality of Life scores improved 67% (19.0 vs. 5.0; p<0.001). Improvements also were observed in median Gastrointestinal Symptom Rating Scale and SF-36 Health Survey mental and physical composite scores. Median esophageal acid exposure improved significantly (10 vs. 8; p<0.008) with normalization of pH noted in 30% of patients. No significant change in esophageal manometry was noted. One gastric perforation occurred and was managed conservatively without sequelae.

Conclusions

In this study, a single full-thickness plication placed at the gastroesophageal junction reduced symptoms, medication use, and esophageal acid exposure associated with GERD.

Section snippets

Study design

A prospective multicenter protocol was approved by the institutional review boards at 7 participating study sites, with a target enrollment of 64 patients. Written consent was obtained from each patient. All of the following criteria were satisfied for patients enrolled in the study: (1) history of heartburn or regurgitation of at least 6 months' duration; (2) a pH study (conducted within 6 months of enrollment) demonstrating pathologic reflux (defined as the total percentage of time pH<4 or

Results

Sixty-four patients underwent endoscopic full-thickness plication. The average procedure time, defined as the time from EPS instrument insertion to removal, was 17.2 (12.2) minutes. All patients received a single implant/plication, and no repeat procedure was performed. Complete 6-month follow-up data were obtained for 47 patients; 11 additional patients completed questionnaires but refused to repeat the 24-hour esophageal pH study. The characteristics of the study population are shown in Table

Discussion

Although medical therapy is effective in most patients with GERD, many continue to have regurgitation despite use of antisecretory medications, whereas others are unwilling or unable to take medications every day. The need for effective non-pharmacologic therapy also is demonstrated by the rapidly increasing number of laparoscopic surgical antireflux operations being performed since the introduction of that operation in the early 1990s. The potential advantages of an endoscopic vs. a surgical

Disclosure

Sponsored by NDO Surgical, Inc., Mansfield, Mass.

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    • Cited by (0)

    ☆

    Presented at the annual meeting of the American Society for Gastrointestinal Endoscopy Digestive Diseases Week, May 18-21, 2003, Orlando, Florida.

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    Copyright © 2004 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.