RecruitingNot ApplicableNCT03472157

A Randomized Controlled Study Evaluating Bariatric Surgery as a Treatment for Severe NASH With Advanced Liver Fibrosis in Non-severe Obese Patients

Prospective Multicentric, Open Label, Randomized Clinical Trial of Superiority, With Two Arms, Comparing Bariatric Surgery to the Recommended Medical Treatment for NASH


Sponsor

University Hospital, Lille

Enrollment

100 participants

Start Date

Jun 20, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of the study is to demonstrate the superiority of bariatric surgery on the disappearance of NASH without worsening of fibrosis in comparison to medical standard treatment in obese patients (35 kg/m² \> BMI ≥ 30 kg/m²) with NASH complicated of advanced fibrosis (F3 and F4 fibrosis grade according to Brunt score).


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This randomized trial tests whether bariatric (weight loss) surgery — specifically sleeve gastrectomy or gastric bypass — is superior to standard medical treatment for resolving non-alcoholic steatohepatitis (NASH), a serious form of fatty liver disease, in adults with moderate obesity (BMI 30–35 for most patients) who already have advanced liver scarring (fibrosis). NASH can progress to cirrhosis or liver failure, and current medical options are limited. Eligible participants are adults with a BMI of 30 or higher who have confirmed advanced fibrosis (F3 or F4 on liver biopsy or imaging), controlled blood pressure, no prior bariatric surgery, and no decompensated cirrhosis or active cancer. Participation involves liver biopsies at the start and end of the study, either surgery or continued medical management, and follow-up visits over 2 years. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERLifestyle therapy

Lifestyle habits (caloric intake and exercise) + pedometer

PROCEDUREBariatric surgery

Two different types of bariatric surgery can be proposed: laparoscopic Roux-en-Y Gastric Bypass or a Laparoscopic sleeve gastrectomy


Locations(1)

Hôpital Claude Huriez, CHRU

Lille, France

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NCT03472157


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