Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease: A Systematic Review and Meta-Analysis of Randomized Sham Controlled Trials

Introduction

Gastroesophageal reflux disease (GERD) affects approximately 20% of adults in the United States. Proton pump inhibitors are the first-line treatment but are associated with long-term side effects. Endoscopic full-thickness plication (EFTP) is a minimally invasive alternative that improves the valvular mechanism of the gastroesophageal junction. This meta-analysis compared EFTP to a sham procedure for the treatment of refractory GERD.

Materials and Methods

This meta-analysis followed the Cochrane guidelines and PRISMA standards and was registered with PROSPERO (CRD42023485506). We searched MEDLINE, Embase, SCOPUS, and Cochrane Library through December 2023. Inclusion criteria targeted Randomized controlled trials comparing EFTP with sham procedures for GERD were included. Statistical analyses utilized RevMan with a random-effects model, and the results were considered significant at p < 0.05.

Results

Of the 2144 screened studies, three RCTs with 272 patients with GERD were included: 136 patients underwent EFTP and 136 underwent sham procedures. Primary outcomes showed a significant reduction in PPI usage (RR 0.51; 95% CI 0.35–0.73; p < 0.01) and more than 50% improvement in GERD-HRQL scores at 3 months (RR 15.81; 95% CI 1.40–178.71; p = 0.03). No significant difference was found in the DeMeester scores (MD: 12.57; 95% CI −35.12 to 9.98; p = 0.27). Secondary outcomes showed no significant difference in time with esophageal pH < 4, but a significant reduction in total reflux episodes.

Conclusions

EFTP significantly reduced PPI usage, improved GERD-HRQL scores, and decreased total reflux episodes compared with sham procedures, highlighting its potential as a minimally invasive treatment. Further research is needed to compare EFTP with other minimally invasive techniques to determine the most effective treatment option.