ESG Plus Lifestyle Intervention Shows Promise for MASH

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 P P = .005), and ballooning (P P = .007).
• ESG was completed successfully for all patients; however, two patients experienced serious adverse events that required hospitalization, which were resolved conservatively within 72 hours.

IN PRACTICE:

“ESG should be used as part of second-line treatment, with or without other complementary weight loss therapies, especially in patients who do not respond to lifestyle modification,” the authors wrote.

SOURCE:

This study, led by Javier Abad, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain, was published online in Clinical Gastroenterology and Hepatology.

LIMITATIONS:

Study outcomes may have been influenced by the small number of patients with significant fibrosis. Moreover, the unexpected high adherence to lifestyle changes in the SE group may have affected the statistical power of the results.

DISCLOSURES:

This study was funded by a grant from the Carlos III Health Institute and Ministry of Science and Innovation, Government of Spain. Some authors reported receiving grants and research support, consultancy and lecture fees, and/or serving as speakers, consultants, and advisory board members of various pharmaceutical companies. One author reported serving as a proctor for Apollo Endosurgery.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.