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A groundbreaking study conducted in Spain has shown that endoscopic sleeve gastroplasty (ESG) combined with lifestyle interventions can lead to significant weight loss and improved liver health in patients with metabolic dysfunction–associated steatohepatitis (MASH) and obesity. The findings, published in Clinical Gastroenterology and Hepatology, highlight ESG as a promising second-line treatment for individuals who struggle with traditional lifestyle modifications.
Study Highlights
The prospective randomized trial, conducted between April 2018 and December 2020, involved 40 adults with obesity (median body mass index [BMI]: 37.85) and MASH, a severe form of nonalcoholic fatty liver disease (NAFLD). Participants were randomly assigned to receive either ESG or a sham endoscopy (SE), followed by a structured lifestyle program.
The primary goal of the study was to achieve the resolution of MASH without worsening liver fibrosis over 72 weeks. Secondary outcomes included weight loss and changes in liver fat, stiffness, and other key biomarkers.
Key Results
- Weight Loss: Patients in the ESG group achieved an average total body weight loss of 9.47%, significantly more than the 3.91% observed in the SE group. Notably, 94.4% of ESG patients experienced significant weight reduction compared to 57.9% in the SE group.
- Liver Health: ESG led to a notable decrease in liver stiffness (mean reduction of 5.63 kPa vs. 0.2 kPa in the SE group) and steatosis (mean reduction of 0.94 vs. 0.26).
- MASH Resolution: Patients who lost more than 10% of their body weight showed significant improvements in NAFLD activity scores, steatosis, lobular inflammation, and hepatocyte ballooning. A resolution of MASH without fibrosis worsening was achieved in 70% of patients in the >10% weight loss group, compared to 22.2% in those with less weight loss.
Safety and Practical Considerations
ESG was successfully performed in all patients, with two experiencing serious but quickly resolved adverse events. The authors emphasized that ESG should be considered a second-line treatment, particularly for patients unresponsive to lifestyle-only interventions.
Study Limitations
The trial’s results may have been influenced by the small sample size, particularly the number of patients with significant fibrosis. Additionally, unexpectedly high adherence to lifestyle changes in the SE group may have reduced the statistical power of the findings.
Expert Opinion
“ESG represents an effective strategy for addressing obesity-related liver disease when lifestyle modifications alone are insufficient,” stated Javier Abad, lead author of the study from Hospital Universitario Puerta de Hierro Majadahonda in Madrid.
Funding and Disclosures
The study was funded by the Carlos III Health Institute and the Spanish Ministry of Science and Innovation. Some authors disclosed receiving support or serving in advisory roles for pharmaceutical companies.
This trial paves the way for integrating endoscopic procedures like ESG with comprehensive lifestyle changes to treat complex conditions like MASH and obesity. Further research with larger cohorts is needed to confirm these promising results.
