Multicenter, double-blind, sham endoscopy-controlled, randomized trial evaluating the efficacy of antireflux mucosal ablation for the treatment of gastroesophageal reflux disease

BACKGROUND: Antireflux mucosal ablation (ARMA) is a novel endoscopic technique for gastroesophageal reflux disease (GERD) but has only been assessed in noncontrolled studies. The objective of this randomized controlled study was to evaluate its efficacy in patients with proton pump inhibitor (PPI)-responsive GERD. METHODS: We conducted a double-blind, sham endoscopy-controlled, randomized trial across 12 Spanish hospitals. Adults with PPI-responsive GERD and abnormal esophageal acid exposure time (AET > 6 %) were randomly assigned (1:1) to receive ARMA or sham endoscopy. The primary outcome was clinical success at 12 months, defined as a ≥ 50 % reduction in the GERD-Health-Related Quality of Life score. Inability to discontinue PPIs to allow symptom assessment was considered treatment failure. Secondary outcomes included PPI discontinuation, AET, manometric parameters, mucosal healing, and adverse events. RESULTS: = 0.29; risk ratio 1.36, 95 %CI 0.76 to 2.42). No significant differences were observed in PPI discontinuation, AET, manometric findings, or mucosal healing. Postprocedural pain (27.3 % vs. 3.3 %) and dysphagia (45.5 % vs. 10.0 %) occurred more frequently in the ARMA group. No severe adverse events were recorded. CONCLUSIONS: ARMA was not superior to sham endoscopy in improving GERD-related quality of life at 12 months in patients with PPI-responsive GERD, and was associated with a higher incidence of adverse events. These findings do not support its implementation in routine clinical practice.