Role of antireflux mucosal ablation in "reflux-predominant" refractory gastroesophageal reflux disease: a randomized sham-controlled trial.

BACKGROUND

Refractory gastroesophageal reflux disease (GERD) often requires endoscopic or surgical intervention. We evaluated the efficacy of antireflux mucosal ablation (ARMA) versus sham treatment in patients with reflux-predominant refractory GERD.

METHODS

This single-center, randomized sham-controlled trial enrolled patients with persistent GERD symptoms on optimized proton pump inhibitor (PPI) therapy, with acid exposure time (AET) <6%, and >80 reflux episodes on 24-hour pH-impedance monitoring. Patients were randomized to the ARMA or sham groups. The primary outcome was the proportion of patients achieving 50% improvement in GERD health-related quality-of-life (GERD-HRQL) score from baseline to 6 months. Secondary outcomes included heartburn and regurgitation symptom scores, AET, DeMeester score, reflux episodes, endoscopy findings, and PPI consumption. Mixed-effects models were applied, with group (ARMA vs. sham) as fixed effect and participant as random effect.

RESULTS

58 patients (ARMA, n = 28; median age 41; 32% women vs. sham, n = 30; median age 40; 36% women) were included. Baseline mean (SD) duration of PPI use was similar: ARMA, 3.5 (2.7) years; sham, 3.7 (1.8) years. At 6 months, 20 of the ARMA group (71.4%) achieved ≥50% GERD-HRQL score reduction vs. one in the sham group (3.6%; P <0.001). Statistically significant reductions in heartburn, regurgitation, AET, and reflux episodes were seen with ARMA versus sham (P <0.05). Interaction effects revealed greater improvements over time with ARMA versus sham for AET (P = 0.03), total reflux episodes (P = 0.001), and nonacid reflux episodes (P = 0.009), but not for DeMeester score. The ARMA group improved in endoscopic Hill's grading and esophagitis at 6 months; 35.7% of patients were completely off PPIs.

CONCLUSION

ARMA improves symptoms, AET, and reflux episodes in reflux-predominant PPI-refractory GERD.