Anti-reflux mucosal ablation (ARMA) as a new treatment for gastroesophageal reflux refractory to proton pump inhibitors: a pilot study
Haruhiro Inoue, Mayo Tanabe, Enrique Rodríguez de Santiago, Mary Raina Angeli Abad, Yuto Shimamura, Yusuke Fujiyoshi, Akiko Ueno, Kazuya Sumi, Hideomi Tomida, Yugo Iwaya, Haruo Ikeda, Manabu Onimaru
Abstract
Abstract Background The incidence of proton pump inhibitor (PPI)-refractory gastroesophageal reflux disease (GERD) has been increasing. While surgical intervention with Laparoscopic Nissen Fundoplication remains the gold standard, less invasive anti-reflux interventions are desired. We have developed a minimally invasive anti-reflux mucosal ablation (ARMA) treatment. Herein, we report its technical details and describe its feasibility, safety, and efficacy in PPI-refractory GERD. Methods We conducted a prospective single-center single-arm interventional trial evaluating the outcome of ARMA in 12 patients with PPI-refractory GERD. GERD-Health Related Quality of Life Questionnaire (GERD-HRQL) evaluation, Frequency Scale for the Symptoms of GERD (FSSG) assessment, and impedance-pH monitoring were performed at baseline and at 2 months post-ARMA. Results A total of 12 patients underwent ARMA with a median follow-up duration of 9 months (range: 6 – 14 months). Median GERD-HRQL score significantly improved from 30.5 to 12 (P = 0.002); median FSSG score significantly improved from 25 to 10.5 (P = 0.002), and median DeMeester score decreased from 33.5 to 2.8 (P = 0.049) at 2 months follow-up. No immediate complications were observed. Conclusion Our pilot study has shown that ARMA, a new endoscopic treatment for PPI-refractory GERD, is simple, safe, and improves GERD-related symptoms and objective acid reflux parameters.