Transoral, flexible endoscopic suturing for treatment of GERD: A multicenter trial

Background: A totally transoral outpatient procedure for the treatment of GERD would be appealing. Methods: A multicenter trial was initiated that included 64 patients with GERD treated with an endoscopic suturing device. Inclusion criteria were 3 or more heartburn episodes per week while not taking medication, dependency on antisecretory medicine, and documented acid reflux by pH monitoring. Exclusion criteria were dysphagia, grade 3 or 4 esophagitis, obesity, and hiatus hernia greater than 2 cm in length. Patients underwent manometry, endoscopy, 24-hour pH monitoring, and symptom severity scoring before and after the procedure. Patients were randomized to a linear or circumferential plication configuration. Adverse procedural events were recorded. Results: Mean 6-month symptom score changes demonstrated procedural efficacy. Heartburn severity and frequency as well as regurgitation all improved ( p > 0.0001 for each). Twenty-four−hour pH monitoring showed improvement in number of episodes below pH of 4 at 3 and 6 months ( p < 0.0007 and 0.0002) and percentage of total time the pH was less than 4 at 6 months ( p < 0.011). Plication configuration did not affect symptoms or pH monitoring results. One patient had a self-contained suture perforation that was successfully treated with antibiotics. Conclusion: Endoscopic gastroplasty is safe. It is associated with reduced symptoms and medication use at 6 month follow-up in patients with uncomplicated GERD. (Gastrointest Endosc 2001;53:416-22.)