Can Weight-Loss surgery reverse severe fatty liver disease?
NCT ID NCT03472157
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if weight-loss surgery is better than standard medical treatment for making nonalcoholic steatohepatitis (NASH) with advanced liver scarring disappear without making the scarring worse. It involves 100 obese adults with NASH and significant liver fibrosis. Participants are randomly assigned to either bariatric surgery or continued medical management, and the main goal is to see if NASH clears up on a liver biopsy.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2018
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hôpital Claude Huriez, CHRU
RECRUITINGLille, France
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