TOPLINE:Endoscopic sleeve gastroplasty (ESG) combined with lifestyle changes leads to significant weight loss and improves liver health in patients with metabolic dysfunction–associated steatohepatitis (MASH) and obesity over 72 weeks.
METHODOLOGY:A prospective randomized trial was conducted in four centers in Spain from April 2018 to December 2020 to assess the effectiveness and safety of ESG as a treatment for MASH in adults with obesity (body mass index [BMI], ≥ 30).Participants had stage 0-3 fibrosis, a histological nonalcoholic fatty liver disease (NAFLD) activity score ≥ 3, and a score ≥ 1 for both lobular inflammation and hepatocyte ballooning.Patients were randomly assigned to undergo ESG, conducted using an endoscopic suture system, or a sham endoscopy (SE), which involved a diagnostic upper endoscopy.Patients in both the ESG and SE cohorts followed a liquid diet for the first 2 weeks before the procedure, and a shredded diet for the next 2 weeks and a hypocaloric diet of 1500 kcal for 2 months after the procedure, followed by lifestyle interventions that included a low-calorie Mediterranean diet, daily walking, and physical exercise for the remainder of the study.The primary outcome was the resolution of MASH without worsening of fibrosis over a 72-week follow-up period. The secondary outcomes included changes in body weight and liver fat, stiffness, fibrosis, and biochemistry.TAKEAWAY:Investigators randomized 40 patients (median age, 56.5 years; mean BMI, 37.85; 55% men), with 18 in the ESG group and 19 in the SE group completing the 72-week follow-up and receiving end-of-study liver biopsy.ESG vs SE resulted in a total body weight loss of 9.47% vs 3.91%, with a significant reduction in body weight observed in 94.4% patients in the ESG group vs 57.9% in the SE group.ESG vs SE led to a significant reduction in liver stiffness by a mean of 5.63 vs 0.2 kPa (P=.017) and in steatosis by a mean of 0.94 vs 0.26 (P=.033).Compared with patients achieving 10% weight loss showed a significant improvement in the NAFLD activity score (P
Source : Medscape