Endoscopic Sleeve Gastroplasty Plus Lifestyle Intervention in Patients With Metabolic Dysfunction-associated Steatohepatitis: A Multicenter, Sham-controlled, Randomized Trial

IF 12 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Clinical Gastroenterology and Hepatology Pub Date : 2025-08-01 Epub Date: 2024-12-16 DOI:10.1016/j.cgh.2024.10.027

Javier Abad , Elba Llop , María Teresa Arias-Loste , Diego Burgos-Santamaría , José Luis Martínez Porras , Paula Iruzubieta , Javier Graus , Belén Ruiz-Antorán , María Rosario Sánchez Yuste , Manuel Romero-Gómez , Agustin Albillos , Javier Crespo , José Luis Calleja

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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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内镜下套筒胃成形术加生活方式干预治疗MASH患者：一项多中心、假对照、随机试验。

背景和目的：代谢功能障碍相关脂肪性肝炎（MASH）常见于活检证实的脂肪性肝病（SLD）。生活方式干预使体重减轻10%以上，可促进MASH的解决，但这一目标仅由少数患者实现。内镜下套管胃成形术（ESG）最近成为一种安全有效的选择，以促进肥胖人群减肥。我们报告了一项多中心、随机、对照和双盲研究的结果，以评估ESG治疗MASH患者的有效性和安全性。方法：40名患者按1:1的比例随机分为ESG +生活方式改变组和假内镜(SE) +生活方式干预组。纳入标准包括活检证实的MASH， NAS≥3，纤维化分期F0-F3。ESG组18例，ESI组19例，随访72周。结果：ESG组总体重减轻（TBWL）为9.47%（±9.38），ESI组为3.91%（±5.43）（p < 10%）。我们发现NAS评分显著改善（-4±0.94比-0.81±1.62,p < 0.05）

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来源期刊

Clinical Gastroenterology and Hepatology 医学-胃肠肝病学

CiteScore

16.90

自引率

4.80%

发文量

903

审稿时长

22 days

期刊介绍： Clinical Gastroenterology and Hepatology (CGH) is dedicated to offering readers a comprehensive exploration of themes in clinical gastroenterology and hepatology. Encompassing diagnostic, endoscopic, interventional, and therapeutic advances, the journal covers areas such as cancer, inflammatory diseases, functional gastrointestinal disorders, nutrition, absorption, and secretion. As a peer-reviewed publication, CGH features original articles and scholarly reviews, ensuring immediate relevance to the practice of gastroenterology and hepatology. Beyond peer-reviewed content, the journal includes invited key reviews and articles on endoscopy/practice-based technology, health-care policy, and practice management. Multimedia elements, including images, video abstracts, and podcasts, enhance the reader's experience. CGH remains actively engaged with its audience through updates and commentary shared via platforms such as Facebook and Twitter.