Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease: A randomized, sham-controlled trial

Gastroenterology. 2006 Sep;131(3):704-12. doi: 10.1053/j.gastro.2006.07.004.


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 > or =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 > or =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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Endoscopy, Gastrointestinal*
  • Equipment Design
  • Female
  • Follow-Up Studies
  • Fundoplication / instrumentation*
  • Gastric Acidity Determination
  • Gastroesophageal Reflux / metabolism
  • Gastroesophageal Reflux / psychology
  • Gastroesophageal Reflux / surgery*
  • Humans
  • Hydrogen-Ion Concentration
  • Male
  • Middle Aged
  • Prospective Studies
  • Quality of Life
  • Single-Blind Method
  • Treatment Outcome