Efficacy and safety of endoscopic sleeve gastroplasty for patients with metabolic dysfunction-associated steatohepatitis: protocol for a systematic review and trial sequential meta-analysis

BACKGROUND: Metabolic dysfunction-associated steatohepatitis (MASH) represents a progressive form of liver disease with rising global prevalence, where sustained weight loss is essential for histological improvement. Current therapies-lifestyle modification, pharmacotherapy, and bariatric surgery-face limitations including variable efficacy, cost, invasiveness, or accessibility. Endoscopic sleeve gastroplasty (ESG) emerges as a minimally invasive alternative for moderate obesity, demonstrating promising weight loss and preliminary metabolic benefits. However, robust evidence regarding its impact on core histological outcomes remains limited and heterogeneous, necessitating a systematic evaluation to establish its therapeutic role in MASH management. METHODS AND ANALYSIS: Randomized controlled trials (RCTs) and cohort studies that compare endoscopic sleeve gastroplasty and usual care in patients with metabolic dysfunction-associated steatohepatitis will be included. Literature searches will be conducted in PubMed, Web of Science, Embase, and Cochrane Library. Two reviewers will independently perform the processes of literature retrieval, screening, data extraction, and assessment of risk of bias. The primary outcome is total body weight loss (TBWL). Secondary outcomes include resolution of MASH without worsening of fibrosis, improvement in fibrosis without worsening of steatohepatitis, and incidence of adverse events. Risk of bias in included RCTs will be evaluated using Revised Cochrane risk-of-bias tool (ROB 2) for RCTs. Review Manager (RevMan) will be used for data pooling. Effect estimates will be expressed as risk ratios (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes, with 95% confidence intervals (CI). Subgroup analysis, trial sequential analysis (TSA), and sensitivity analysis will be conducted. ETHICS AND DISSEMINATION: Ethical approval is not required because this study is a secondary analysis of existing data. We will disseminate the findings through peer- reviewed publications. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD420251121461.