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

Background: A totally transoral outpatient procedure far the treatment of G ERD would be appealing. Methods: A multicenter trial was initiated that included 64 patients with G ERD treated with an endoscopic suturing device. Inclusion criteria were 3 o r more heartburn episodes per week while not taking medication, dependency on antisecretory medicine, and documented acid reflux by pH monitoring. Exc lusion criteria were dysphagia, grade 3 or 4 esophagitis, obesity, and hiat us hernia greater than 2 cm in length. Patients underwent manometry, endosc opy, 24-hour pH monitoring, and symptom severity scoring before and after t he procedure. Patients were randomized to a linear or circumferential plica tion configuration. Adverse procedural events were recorded. Results: Mean 6-month symptom score changes demonstrated procedural efficac y. 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 uncomplic ated GERD.