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.
