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RECRUITING
NCT03472157
NA

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

Sponsor: University Hospital, Lille

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2018-06-20

Completion Date

2026-10

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

OTHER

Lifestyle therapy

Lifestyle habits (caloric intake and exercise) + pedometer

PROCEDURE

Bariatric 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