Abstract
BACKGROUND AND AIMS: Obesity-related Gastroesophageal Reflux Disease (GERD) presents a significant clinical challenge, limited by the effectiveness of current treatments. Excess weight impairs the repair of the anti-reflux barrier, and conventional obesity treatments may adversely affect anti-reflux physiology. This study systematically evaluates a modular endoscopic technique that combines Transoral Incisionless Fundoplication (TIF) with Endoscopic Sleeve Gastroplasty (ESG) simultaneously (F-ESG), offering a synergistic solution to both GERD and obesity. METHODS: This single-center pilot study enrolled adults with objectively confirmed pathologic GERD and incomplete symptomatic response to proton pump inhibitor therapy. Participants underwent the combined F-ESG procedure with standardized dietary and behavioral counseling. Outcomes were assessed at baseline, 6 months, and 12 months, including percent total weight loss (%TWL), GERD Health-Related Quality of Life (HRQL), Reflux Symptom Index (RSI), and DeMeester score (DMS) obtained from 48-hour pH monitoring. RESULTS: Eight participants (mean age 39 ± 6.4 years; 75% female; mean BMI 34.5 ± 3.7 kg/m²) were included. Mean %TWL was 13.1% at 6 months and 15.2% at 12 months. GERD HRQL improved from 26.4 at baseline to 8.3 at 6 months and 8.5 at 12 months (p < 0.01). RSI and DMS also demonstrated significant reductions. By 12 months, all participants had discontinued PPI therapy, and 7 of 8 achieved a normalized DeMeester score. CONCLUSIONS: In this single-center pilot study, same-session F-ESG was feasible and safe, with improvements in subjective and objective GERD metrics and weight loss through 12 months. Larger multicenter comparative studies are warranted to evaluate efficacy and durability.