Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease: A Randomized, Sham-Controlled Trial

Richard Rothstein, Charles Filipi, Karel Caca, Ronald Pruitt, Klaus Mergener, Alfonso Torquati, Gregory Haber, Yang Chen, Kenneth Chang, David Wong, Jacques Deviere, Douglas Pleskow, Charles Lightdale, Alain Ades, Richard Kozarek, William Richards, Anthony Lembo

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Abstract

Background & Aims: The aim of this study was to determine the effectiveness of endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease (GERD) in comparison with a sham procedure. Methods: Patients with symptomatic GERD requiring maintenance proton pump inhibitor (PPI) therapy were entered into a randomized, single-blind, prospective, multicenter trial. Seventy-eight patients were randomly assigned to undergo endoscopic full-thickness restructuring of the gastric cardia with transmural suture. Eighty-one patients underwent a sham procedure. Group assignments were revealed following the 3-month evaluation. The primary end point was ≥50% improvement in GERD health-related quality of life (HRQL) score. Secondary end points included medication use and esophageal acid exposure. Results: By intention-to-treat analysis, at 3 months, the proportion of patients achieving ≥50% improvement in GERD-HRQL score was significantly greater in the active group (56%) compared with the sham group (18.5%; P <.001). Complete cessation of PPI therapy was higher among patients in the active group than in the sham group by intention-to-treat analysis (50% vs 24%; P = .002). The percent reduction in median percent time pH <4 was significantly improved within the active group versus baseline (7 vs 10, 18%, P <.001) but not in the sham group (10 vs 9, -3%, P = .686). Between-group analysis revealed the active therapy to be superior to the sham in improving median percent time pH <4 (P = .010). There were no perforations or deaths. Conclusions: Endoscopic full-thickness plication more effectively reduces GERD symptoms, PPI use, and esophageal acid exposure than a sham procedure.

Original languageEnglish
Pages (from-to)704-712
Number of pages9
JournalGastroenterology
Volume131
Issue number3
DOIs
StatePublished - Sep 2006

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All Science Journal Classification (ASJC) codes

  • Gastroenterology

Cite this

Rothstein, R., Filipi, C., Caca, K., Pruitt, R., Mergener, K., Torquati, A., Haber, G., Chen, Y., Chang, K., Wong, D., Deviere, J., Pleskow, D., Lightdale, C., Ades, A., Kozarek, R., Richards, W., & Lembo, A. (2006). Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease: A Randomized, Sham-Controlled Trial. Gastroenterology, 131(3), 704-712. https://doi.org/10.1053/j.gastro.2006.07.004