Endoscopic sleeve gastroplasty plus lifestyle intervention in patients with MASH: a multicentre, sham-controlled, randomized trial.

Abstract

Background and aims: Metabolic dysfunction-associated steatohepatitis(MASH) is commonly seen in biopsy proven steatotic liver disease(SLD). Life-style intervention reaching a weight loss higher than 10% promotes MASH resolution, but this goal is only achieved by a small number of patients. Endoscopic sleeve gastroplasty(ESG) has recently emerged as a safe and effective option to promote weight loss in obese population. We report the results of a multicenter, randomized, controlled and double-blind study to evaluate the effectiveness and safety of ESG in MASH patients METHODS: Forty patients were randomized 1:1 to ESG plus lifestyle modification vs. sham endoscopy (SE) plus lifestyle intervention. Inclusion criteria included biopsy proven MASH with NAS≥3 and fibrosis stage F0-F3. Eighteen patients from the ESG group and 19 from the ESI group completed follow-up during 72 weeks. Baseline to end of follow-up changes in body weight, liver tests, liver stiffness(VCTE) and liver histology were recorded RESULTS: Total Body weight loss(TBWL) was 9.47%(±9.38) in ESG group vs 3.91%(±5.43) in ESI group(p<0.05). Liver stiffness decreased 5.63(±7.17) KPa in ESG group vs 0.2(±5.38) KPa in ESI group(p<0.05). Steatosis was significantly reduced in ESG group(-0.94±0.87) vs ESI group(-0.26±0.99)[p= 0.033]. No differences on NAS(-1.89±2.11 vs -1.47±2.01) score neither fibrosis(-0.1±0.91 vs -0.84±1.21) was seen. In patients achieving weight loss>10% we found a significant improvement on NAS score(-4±0.94 vs. -0.81±1.62, p<0.01), but not in fibrosis stage(-0.3±1.06 vs -0.59±1.25). Only 2 patients of ESG group had adverse events that required admission that resolved conservatively in 72 hours CONCLUSION: ESG is an effective and safe method to promote weight reduction associated with significant improvement in patients with MASH and obesity.