Endoscopic full-thickness plication for the treatment of GERD: A multicenter trial

Douglas Pleskow, Richard Rothstein, Simon Lo, Robert Hawes, Richard Kozarek, Gregory Haber, Christopher Gostout, Anthony Lembo

Research output: Contribution to journalArticle

111 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)163-171
Number of pages9
JournalGastrointestinal endoscopy
Volume59
Issue number2
DOIs
StatePublished - Feb 1 2004

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

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    Pleskow, D., Rothstein, R., Lo, S., Hawes, R., Kozarek, R., Haber, G., Gostout, C., & Lembo, A. (2004). Endoscopic full-thickness plication for the treatment of GERD: A multicenter trial. Gastrointestinal endoscopy, 59(2), 163-171. https://doi.org/10.1016/S0016-5107(03)02542-2