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Endoscopy
DOI: 10.1055/a-2740-9297
Original article

Role of anti-reflux mucosal ablation in “reflux-predominant” refractory gastro-esophageal reflux disease patients - a randomized sham controlled trial

Authors

  • Digvijay Chavan

    1   Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India (Ringgold ID: RIN78470)

  • Krithi Krishna Koduri 

    2   Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India (Ringgold ID: RIN78470)

  • Aniruddha Pratap Singh

    1   Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India (Ringgold ID: RIN78470)
    3   Medical gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India (Ringgold ID: RIN78470)

  • Rajesh Goud Maragoni

    1   Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India (Ringgold ID: RIN78470)

  • Nitin Jagtap 

    4   medical gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India (Ringgold ID: RIN78470)

  • Rakesh Kalapala

    5   Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India

  • Nageshwar D. Reddy

    5   Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India

Clinical Trial:

Registration number (trial ID): NCT05899491, Trial registry: ClinicalTrials.gov (http://www.clinicaltrials.gov/), Type of Study: Randomized sham controlled trial


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Background & Aim Refractory gastroesophageal reflux disease(GERD) often requires endoscopic or surgical intervention. This randomised controlled trial(RCT) evaluated the efficacy of anti-reflux mucosal ablation(ARMA) compared to sham in patients with “reflux-predominant” refractory GERD. Methods: This single-center, randomized, sham-controlled trial enrolled patients with persistent GERD symptoms on optimized PPI therapy, with Acid Exposure Time(AET) <6%, and >80 reflux episodes on 24-hour-pH-impedance monitoring. Patients were randomized to ARMA or sham group. The primary outcome was proportion of patients achieving 50% improvement in GERD health-related quality-of-life(GERD-HRQL) score from baseline toat 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 a fixed effect and participant as random effect. Results: Fifty-eight patients(ARMA: n=28, median age 41, 32.1% female; Sham: n=30, median age 40, 35.7% female) were included. Baseline mean PPI-use duration was similar(ARMA:3.5±2.7 years, Sham: 3.7±1.8 years). At 6 months, 20(71.4%) of ARMA patients achieved ≥50% GERD-HRQL score reduction vs. 1(3.6%) in sham(p<0.001). Statistically Ssignificant reductions in heartburn, regurgitation, AET, and reflux episodes were seen in ARMA compared to sham(p<0.05). Interaction effects revealed greater improvements over time in ARMA group compared to sham for AET(p=0.029), total reflux episodes(p=0.001), and non-acid reflux episodes(p=0.009), not for DeMeester score(p>0.05). The ARMA group, had significant improvement in endoscopic Hill’s grading and esophagitis at 6 months and 35.7% patients were completely off PPIs. Conclusion: ARMA significantly improves symptoms, AET, and reflux episodes in “reflux predominant” PPI-refractory GERD.



Publication History

Received: 07 April 2025

Accepted after revision: 06 November 2025

Accepted Manuscript online:
06 November 2025

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