Evaluating bariatric surgery for treating severe liver disease in obese patients
Official title: Prospective Multicentric, Open Label, Randomized Clinical Trial of Superiority, With Two Arms, Comparing Bariatric Surgery to the Recommended Medical Treatment for NASH
Run by University Hospital, Lille · NCT03472157 · Data updated 2026-11-12
This study is testing whether bariatric surgery can help obese patients with severe liver disease get better compared to standard medical treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University Hospital, Lille Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Lille) |
| Status | Recruiting |
| Started | June 20, 2018 |
| Main results expected | June 20, 2028 |
| Study ends | June 20, 2028 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT03472157 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are obese patients with a BMI between 30 and 50 who have been diagnosed with advanced fibrosis due to NASH.
✕Probably not a fit
Patients with mild obesity or those without advanced fibrosis may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to compare the effectiveness of bariatric surgery against standard medical treatment for obese patients suffering from severe nonalcoholic steatohepatitis (NASH) with advanced liver fibrosis. Participants will be randomized to receive either lifestyle therapy or surgical intervention, specifically gastric bypass or sleeve gastrectomy. The primary goal is to assess whether bariatric surgery can lead to the disappearance of NASH without worsening liver fibrosis. Eligible patients must meet specific BMI and fibrosis criteria, and agree to undergo a liver biopsy as part of the screening process.
Why it matters
Potential benefit: If successful, this approach could significantly improve liver health and overall outcomes for patients with severe NASH and advanced fibrosis.
How similar studies have gone: Previous studies have shown promising results for bariatric surgery in improving liver conditions, suggesting this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provide written informed consent and agree to comply to the study protocol prior to enrolment. * BMI and Brunt Fibriosis score: * For F3 fibrosis patients: 35\>BMI≥ 30kg/m² ; Fibroscan ≥ 9kPa or FibrometreVM ≥0.526 predicting a F3 fibrosis score grade within 1 month before inclusion or F3 fibrosis score grade diagnosed by hepatic biopsy performed before inclusion. * For F4 fibrosis patients: 50\>BMI≥ 30kg/m² ; Fibroscan ≥ 15kPa predicting a F4 fibrosis score grade within 1 month before inclusion or F4 fibrosis score grade diagnosed by hepatic biopsy performed before inclusion. * Fibroscan ≥ 9kPa or FibrometreVM ≥0.526 predicting a F3 or F4 fibrosis score grade within 1 month before inclusion Or F3 or F4 fibrosis score grade diagnosed by hepatic biopsy performed before inclusion. * Patient should agree to have one liver biopsy during the screening period (before randomization, the randomization will be permitted after at least a second reading performed by pathologist of CHRU Lille to confirm the histological diagnosis of NASH with advanced fibrosis (F3-F4)) for the diagnosis purpose (if no histological biopsy within 1 month before inclusion is available) and one at the end of the treatment period for assessment of the treatment effects. * For patients with cirrhosis, patients must fulfil all the following criteria: Platelets \> 125 000, PT \> 80 %, Albumin \> 35 g/L, MELD score at inclusion \< 9, CPT score \< 6, No history of previous decompensation, No oesophageal varices (endoscopy), No vascular shunt, ASA score ≤ III, Alcohol consumption lower than 20g/day for women and 30g/day for men. * For hypertensive patients, hypertension must be controlled by stable dose of anti-hypertensive medication for at least 2 months prior to screening (and the stable dose can be maintained throughout the study). * Female participating in the study must be either of non-child bearing (surgically sterilized at 6 month prior to screening or postmenopausal) or using an efficient contraception: hormonal contraception (including patch, contraceptive ring etc) intra-uterine device or other mechanical contraception * Patient agrees to come to the study visits within the protocol-specified delay Exclusion Criteria: * Previous history of bariatric surgery (except gastric ring removed for more than 3 years). * Decompensated cirrhosis (MELD\> 7 CPT score\> 5, previous history of decompensation (encephalopathy, ascites, jaundice, varicose vein rupture) * Hepatocellular carcinoma * Platelets \<125 000; TP \<80%; bilirubin \<20 mmol / l; albumin \<35 g / L. * Other liver disease: alcohol consumption exceeding 20 g / day for women and 30g / day in men, HBV, HCV, CBP, CSP, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin. * Being processed Cancer (chemotherapy, radiotherapy or hormone therapy) * HIV positive patients * Patients who had an acute cardiovascular episode, coronary Heart Disease (Angina pectoris, myocardial infarction, revascularization procedure), stroke or TIA (Transient Ischemic Attack) within the 6 months prior to screening Recent cardiovascular events (stroke, myocardial infarcts, etc…) in the past 6 months. * Severe chronic respiratory disease. * Severe chronic cardiac insufficiency (grade III and IV of NYHA classification). * Pregnant or breastfeeding women. * Simultaneous enrollment in another clinical trial. * Drug abuse within the past year. * Patient with contra-indication for bariatric surgery * Gastic Banding, Biliopancreatic diversion and all the new bariatric surgery techniques are forbidden because the study design allow only the laparoscopic sleeve gastrectomy or laparoscopic Roux-en-Y gastric Bypaass. * History of cancer, except: * Patients considered in remission for at least 5 years after onset of treatment. * Patients Treated and believed to be cured basal or squamous cell carcinoma of the skin or resected carcinoma of the cervix
Where it's running
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Hôpital Claude Huriez, CHRU
Lille, France Recruiting
Study contacts
- Principal investigator: Philippe Mathurin, MD,PhD — University Hospital, Lille
- Study coordinator: Philippe Mathurin, MD,PhD
- Email: philippe.mathurin@chru-lille.fr
- Phone: 3 20 44 53 21
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.