Endoscopic Sleeve Gastroplasty Plus Lifestyle Intervention in Patients With Metabolic Dysfunction-associated Steatohepatitis: A Multicenter, Sham-controlled, Randomized Trial

Abstract

Background & aims: Metabolic dysfunction-associated steatohepatitis (MASH) is commonly seen in biopsy-proven steatotic liver disease. Lifestyle 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 the obese population. We report the results of a multicenter, randomized, controlled, and double-blind study to evaluate the effectiveness and safety of ESG in patients with MASH.

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 nonalcoholic fatty liver disease activity score (NAS) ≥3 and fibrosis stage F0 to F3. Eighteen patients from the ESG group and 19 from the endoscopic simulated intervention (ESI) group completed follow-up over 72 weeks. Baseline to end of follow-up changes in body weight, liver tests, liver stiffness (vibration-controlled transient elastography), and liver histology were recorded RESULTS: Total body weight loss (TBWL) was 9.47% (±9.38%) in the ESG group vs 3.91% (±5.43%) in the ESI group (P < .05). Liver stiffness decreased 5.63 (±7.17) KPa in the ESG group vs 0.2 (±5.38) KPa in the ESI group (P < .05). Steatosis was significantly reduced in the ESG group (-0.94 ± 0.87) vs the ESI group (-0.26 ± 0.99) (P = .033). No differences on NAS (-1.89 ± 2.11 vs -1.47 ± 2.01) score or 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 < .01), but not in fibrosis stage (-0.3 ± 1.06 vs -0.59 ± 1.25). Only 2 patients from the ESG group had adverse events that required admission; these 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.

Clinicaltrials: gov, Number: NCT03426111.

Keywords: Bariatric Endoscopy; Endoscopic Sleeve Gastroplasty (ESG); Metabolic Dysfunction-associated Steatohepatitis (MASH); Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD); Nonalcoholic Fatty Liver Disease (NAFLD); Nonalcoholic Steatohepatitis (NASH).