TOP LINE:
Endoscopic sleeve gastroplasty (ESG) combined with lifestyle changes results in 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 evaluate the effectiveness and safety of ESG as a treatment for MASH in obese adults (body mass index (BMI) ≥ 30) .
- Participants had stage 0 to 3 fibrosis, a histologic nonalcoholic fatty liver disease (NAFLD) activity score ≥ 3, and a score ≥ 1 for lobular inflammation and hepatocyte swelling.
- Patients were randomly assigned to undergo ESG, performed using an endoscopic suture system, or sham endoscopy (SE), which involved diagnostic upper endoscopy.
- Patients in the ESG and SE cohorts followed a liquid diet for the first 2 weeks before surgery, a chopped diet for the next 2 weeks, and a 1,500 kcal hypocalorie diet for 2 months after surgery, followed by lifestyle interventions including a low-calorie Mediterranean diet, daily walking, and physical exercise for the remainder of the study.
- The primary endpoint was resolution of MASH without worsening of fibrosis over a 72-week follow-up period. Secondary outcomes included changes in body weight and liver fat, stiffness, fibrosis, and biochemistry.
TAKE AWAY:
- Investigators randomized 40 patients (median age: 56.5 years; mean BMI: 37.85; 55% male), with 18 in the ESG group and 19 in the SE group completing the 72-week follow-up and receiving a end-of-study liver biopsy. .
- ESG vs SE resulted in a total body weight loss of 9.47% versus 3.91%, with a significant reduction in body weight observed in 94.4% of patients in the ESG group versus 57.9% in the SE group.
- ESG versus SE resulted in a significant reduction in liver stiffness averaging 5.63 versus 0.2 kPa (P. = 0.017) and in steatosis on average 0.94 vs 0.26 (P. = 0.033).
- Compared to patients who achieved weight loss < 10 %, ceux ayant atteint une perte de poids > 10% showed significant improvement in NAFLD activity score (P. < 0.001), steatosis (P. < 0.001), lobular inflammation (P. = 0.005) and the swelling (P. < 0.001), with resolution of MASH without worsening of hepatic fibrosis obtained in 22.2% compared to 70% of patients (P. = 0.007).
- ESG was successfully performed for all patients; however, two patients experienced serious adverse events requiring hospitalization, which resolved conservatively within 72 hours.
IN PRACTICE:
“ESG should be used as a second-line treatment, with or without other complementary weight loss therapies, particularly in patients who do not respond to lifestyle modification,” write the authors.
SOURCE:
This study, led by Javier Abad, Puerta de Hierro Majadahonda University Hospital, Madrid, Spain, was published online In Clinical gastroenterology and hepatology.
BOUNDARIES:
The study results may have been influenced by the small number of patients with significant fibrosis. Additionally, the unexpectedly high adherence to lifestyle changes in the SE group might have affected the statistical power of the results.
DISCLOSURES:
This study was funded by a grant from the Carlos III Health Institute and the Ministry of Science and Innovation of the Spanish government. Some authors reported receiving grants and research support, consulting and speaking fees, and/or serving as speakers, consultants, and advisory board members from various pharmaceutical companies. One author reported having been a supervisor 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.