Actively Recruiting
Prospective Multicentric, Open Label, Randomized Study Comparing Bariatric Surgery to Medical Treatment for NASH with Advanced Liver Fibrosis
Led by University Hospital, Lille · Updated on 2026-04-22
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Lille
Lead Sponsor
M
Ministry of Health, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of bariatric surgery compared to standard medical treatment in obese patients with nonalcoholic steatohepatitis (NASH) complicated by advanced liver fibrosis (grades F3 and F4). This study aims to show whether bariatric surgery leads to the disappearance of NASH without worsening fibrosis in patients with a body mass index (BMI) between 30 and 35 kg/m² for F3 fibrosis, and between 30 and 50 kg/m² for F4 fibrosis. The trial is open-label and randomized, designed to compare surgical intervention with lifestyle therapy.
CONDITIONS
Brief Title
A Randomized Controlled Study Evaluating Bariatric Surgery as a Treatment for Severe NASH With Advanced Liver Fibrosis in Non-severe Obese Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent and agree to comply with the study protocol prior to enrollment
- BMI between 30 and 35 kg/m² for F3 fibrosis or between 30 and 50 kg/m² for F4 fibrosis
- Fibroscan ≥ 9kPa or FibrometreVM ≤ 0.526 predicting F3 or F4 fibrosis within 1 month before inclusion, or hepatic biopsy confirming F3 or F4 fibrosis
- Agree to have one liver biopsy during screening and one at the end of treatment for assessment
- For patients with cirrhosis: platelets > 125,000, PT > 80%, albumin > 35 g/L, MELD score < 9, CPT score < 6, no history of decompensation, no oesophageal varices, no vascular shunt, ASA score ≤ III, and alcohol consumption below defined limits
- Controlled hypertension with stable medication for at least 2 months prior to screening
- Females must be non-childbearing or using effective contraception
- Agree to attend study visits as scheduled
You will not qualify if you...
- Previous bariatric surgery except gastric ring removed more than 3 years ago
- Decompensated cirrhosis or MELD > 7, CPT score > 5, or history of decompensation
- Hepatocellular carcinoma
- Platelets < 125,000; PT < 80%; bilirubin < 20 mmol/L; albumin < 35 g/L
- Other liver diseases such as excessive alcohol use, HBV, HCV, autoimmune hepatitis, hemochromatosis, Wilson's disease, or alpha-1 antitrypsin deficiency
- Active cancer treatment
- HIV positive status
- Recent cardiovascular events within 6 months prior to screening
- Severe chronic respiratory or cardiac insufficiency
- Pregnant or breastfeeding women
- Concurrent enrollment in another clinical trial
- Drug abuse within the past year
- Contraindications for bariatric surgery
- Excluded bariatric surgery types: gastric banding, biliopancreatic diversion, and newer techniques
- History of cancer except patients in remission for at least 5 years or treated basal/squamous cell carcinoma of the skin or resected cervical carcinoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 60 weeks
Participants receive either bariatric surgery with nutritional support and therapeutic education or lifestyle therapy involving diet and increased physical activity.
Regular visits as scheduled during treatment period
Duration - At 60 weeks after randomization
Participants have a liver biopsy and assessments at the end of treatment to evaluate changes in liver condition and metabolic health.
1 visit for end-of-treatment assessment
Trial Site Locations
Total: 1 location
1
Hôpital Claude Huriez, CHRU
Lille, France
Actively Recruiting
Research Team
P
Philippe Mathurin, MD,PhD
G
Guillaume Lassailly, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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