Actively Recruiting
Randomized Study Comparing Bariatric Surgery to Medical Treatment for Severe NASH with Advanced Liver Fibrosis in Non-Severe Obese Patients
Led by University Hospital, Lille · Updated on 2026-04-22
100
Participants Needed
1
Research Sites
521 weeks
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 adults with nonalcoholic steatohepatitis (NASH) complicated by advanced liver fibrosis. The study focuses on patients with a body mass index (BMI) between 30 and 35 kg/m² who have severe fibrosis (F3 or F4 grade) according to the Brunt score. The goal is to see if bariatric surgery can lead to the disappearance of NASH without worsening liver fibrosis. Participants will be randomly assigned to one of two groups: one will receive bariatric surgery, either laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy, while the other will follow lifestyle therapy involving changes in diet and exercise, supported by a pedometer. The study compares these approaches over time to assess their impact on liver health. During the study, participants will have liver biopsies to confirm diagnosis before treatment and to evaluate treatment effects afterward. Liver stiffness measurements and blood tests will monitor fibrosis levels, while adherence to lifestyle changes and medical management will be tracked. The main outcome measured is the rate at which NASH disappears without fibrosis worsening, assessed 60 weeks after randomization. Safety and liver function will be closely observed throughout the study period, which includes regular visits and evaluations.
CONDITIONS
Official 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
- For F3 fibrosis patients: BMI greater than or equal to 30 and less than 35 kg/m²; Fibroscan at least 9 kPa or FibrometreVM at least 0.526 predicting F3 fibrosis within 1 month before inclusion, or F3 diagnosed by liver biopsy before inclusion
- For F4 fibrosis patients: BMI greater than or equal to 30 and less than 50 kg/m²; Fibroscan at least 15 kPa predicting F4 fibrosis within 1 month before inclusion, or F4 diagnosed by liver biopsy before inclusion
- Fibroscan at least 9 kPa or FibrometreVM at least 0.526 predicting F3 or F4 fibrosis within 1 month before inclusion, or F3 or F4 diagnosed by liver biopsy before inclusion
- Agree to have one liver biopsy during screening and one at the end of treatment for assessment
- For patients with cirrhosis: platelets over 125,000; prothrombin time over 80%; albumin over 35 g/L; MELD score less than 9; Child-Pugh score less than 6; no history of decompensation; no oesophageal varices; no vascular shunt; ASA score 3 or less; alcohol consumption below 20 g/day for women and 30 g/day for men
- Hypertension must be controlled by stable medication dose for at least 2 months prior to screening
- Female participants must be non-childbearing (surgically sterilized or postmenopausal) or using effective contraception
- Agree to attend study visits within the scheduled timeframes
You will not qualify if you...
- Previous bariatric surgery except gastric ring removed more than 3 years ago
- Decompensated cirrhosis with MELD above 7 or Child-Pugh above 5, or history of decompensation (encephalopathy, ascites, jaundice, varicose vein rupture)
- Hepatocellular carcinoma
- Platelets below 125,000; prothrombin time below 80%; bilirubin below 20 mmol/L; albumin below 35 g/L
- Other liver diseases such as excessive alcohol use, hepatitis B or C, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency
- Active cancer treatment (chemotherapy, radiotherapy, hormone therapy)
- HIV positive status
- Recent cardiovascular events within 6 months such as stroke, myocardial infarction, or angina
- Severe chronic respiratory or cardiac insufficiency (NYHA grade III or IV)
- Pregnant or breastfeeding women
- Participation in another clinical trial
- Drug abuse within the past year
- Contraindication to bariatric surgery
- Use of excluded bariatric surgery techniques like gastric banding or biliopancreatic diversion
- History of cancer not in remission for at least 5 years, except certain skin or cervical cancers treated and believed cured
AI-Screening
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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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