Endoscopic Sleeve Gastroplasty Plus Lifestyle Intervention in Patients With Metabolic Dysfunction-associated Steatohepatitis: A Multicenter, Sham-controlled, Randomized Trial
Abstract
Background & aims Metabolic dysfunction-associated steatohepatitis (MASH) is commonly seen in biopsy-proven steatotic liver disease. Lifestyle intervention reaching a weight loss higher than 10% promotes MASH resolution, but this goal is only achieved by a small number of patients. Endoscopic sleeve gastroplasty (ESG) has recently emerged as a safe and effective option to promote weight loss in the obese population. We report the results of a multicenter, randomized, controlled, and double-blind study to evaluate the effectiveness and safety of ESG in patients with MASH. Methods Forty patients were randomized 1:1 to ESG plus lifestyle modification vs sham endoscopy (SE) plus lifestyle intervention. Inclusion criteria included biopsy-proven MASH with nonalcoholic fatty liver disease activity score (NAS) ≥3 and fibrosis stage F0 to F3. Eighteen patients from the ESG group and 19 from the endoscopic simulated intervention (ESI) group completed follow-up over 72 weeks. Baseline to end of follow-up changes in body weight, liver tests, liver stiffness (vibration-controlled transient elastography), and liver histology were recorded RESULTS: Total body weight loss (TBWL) was 9.47% (±9.38%) in the ESG group vs 3.91% (±5.43%) in the ESI group (P < .05). Liver stiffness decreased 5.63 (±7.17) KPa in the ESG group vs 0.2 (±5.38) KPa in the ESI group (P < .05). Steatosis was significantly reduced in the ESG group (-0.94 ± 0.87) vs the ESI group (-0.26 ± 0.99) (P = .033). No differences on NAS (-1.89 ± 2.11 vs -1.47 ± 2.01) score or fibrosis (-0.1 ± 0.91 vs -0.84 ± 1.21) was seen. In patients achieving weight loss >10%, we found a significant improvement on NAS score (-4 ± 0.94 vs -0.81 ± 1.62; P < .01), but not in fibrosis stage (-0.3 ± 1.06 vs -0.59 ± 1.25). Only 2 patients from the ESG group had adverse events that required admission; these resolved conservatively in 72 hours. Conclusion ESG is an effective and safe method to promote weight reduction associated with significant improvement in patients with MASH and obesity. Clinicaltrials gov, Number: NCT03426111.
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ESG plus lifestyle modifications significantly reduces liver stiffness compared with sham endoscopy.
“A randomized controlled trial comparing ESG plus lifestyle modifications with a sham endoscopy group found ESG significantly reduced liver stiffness (p < 0.05) [84].”
From Impact of Bariatric Surgery and Endoscopic Therapies on Liver Health in Metabolic Dysfunction-Associated Steatotic Liver Disease: A Review (2025) · cites this paper as [84]
ESG produces a CAP decrease of 41.12 ± 49.41 dB/m (p = 0.067).
“FibroScan (transient elastography) findings: VSG produced the largest CAP score reduction (91.8 dB/m) [39], while ESG had a more modest decrease (41.12 ± 49.41 dB/m; p = 0.067) [84].”
From Impact of Bariatric Surgery and Endoscopic Therapies on Liver Health in Metabolic Dysfunction-Associated Steatotic Liver Disease: A Review (2025) · cites this paper as [84]
ESG reduces NAS by four points in patients with >10% weight loss.
“ESG showed a four-point drop in patients with >10% weight loss [84].”
From Impact of Bariatric Surgery and Endoscopic Therapies on Liver Health in Metabolic Dysfunction-Associated Steatotic Liver Disease: A Review (2025) · cites this paper as [84]
ESG shows gradual improvements in liver stiffness.
“ESG showed gradual improvements [84], while POSE did not significantly change fibrosis [88].”
From Impact of Bariatric Surgery and Endoscopic Therapies on Liver Health in Metabolic Dysfunction-Associated Steatotic Liver Disease: A Review (2025) · cites this paper as [84]
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- Authors
- Abad, J., Llop, E., Arias-Loste, M. T., Burgos-Santamaría, D., Martínez Porras, J. L., Iruzubieta, P., Graus, J., Ruiz-Antorán, B., Sánchez Yuste, M. R., Romero-Gómez, M., Albillos, A., Crespo, J., & Calleja, J. L.
- Affiliations
- Hospital Universitario Puerta de Hierro Majadahonda (ES)
- Universidad de Cantabria (ES)
- Universidad de Alcalá (ES)
- Venue
- Clinical Gastroenterology and Hepatology
- Publisher
- Elsevier BV
- Published
- 2025-08
- Volume
- 23
- Issue
- 9
- Pages
- 1556-1566.e3
- ISSN
- 1542-3565 (ISSN-L)
- OpenAlex
- W4405430026
- Cited by
- 35
- References
- 32
- Citations by year
- 2026: 22 · 2025: 13
- FWCI
- 9.76
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Clinical Gastroenterology and Hepatology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Ministerio de Ciencia e Innovación
- Instituto de Salud Carlos III (FIS PI17/00499)
- Topics
- Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Health Sciences › Medicine › Surgery › Minimally Invasive Surgical Techniques
- Keywords
- endoscopic sleeve gastroplasty, nonalcoholic steatohepatitis, lifestyle intervention, weight loss, non-alcoholic fatty liver disease, liver fibrosis, liver stiffness, steatosis, liver histopathology, obesity, liver enzymes, liver transplant waiting list
- MeSH terms
- Adult, Double-Blind Method, Endoscopy, Fatty Liver, Female, Humans, Life Style, Male, Middle Aged, Gastroplasty, Treatment Outcome, Non-alcoholic Fatty Liver Disease
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