Endoscopic GERD Treatment With Full-Thickness Plication Is Safe and Effective

Gastroesophageal reflux disease (GERD), a relatively common condition impacting up to 40% of the adult population, can be treated with proton pump inhibitors (PPIs), laparoscopic surgical fundoplication, and, more recently, endoscopic modalities. In this randomized controlled trial, the authors investigated the efficacy and safety of a novel, easy-to-use, endoscopic full-thickness fundoplication (EFTP) device in patients with PPI-dependent GERD. 

Seventy patients with PPI-dependent (at least 6 months) GERD were randomized to either EFTP (n=35; median age, 35 years; male, 71%) or sham (same preprocedure and postprocedure steps as in the EFTP group except no sutures were deployed; n=35; median age, 37 years; male, 71%). Patients in both groups were followed at 3-month intervals for a total duration of 12 months. For the primary aim, 66% (23/35) of the patients in the EFTP group versus 3% (1/35) in the sham group showed at least 50% improvement in GERD–health-related quality of life (HRQL) scores (P<.001). The median percentage improvement noted in GERD–HRQL, heartburn, and regurgitation scores in the EFTP group at 3 months persisted at 6 and 12 months (P<.001). There was a significantly lower percentage of patients utilizing PPIs at the end of 12 months in the EFTP group (37%) versus the sham group (89%) (P<.001). There was, however, no statistically significant reduction in the median time of esophageal pH <4 at 3 or 12 months in either group. The mean (±SD) duration of each procedure from the point of endoscope insertion to removal was 17.4 (±4) minutes. No major adverse events were reported.