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Official title A Randomized Controlled Study Evaluating Bariatric Surgery as a Treatment for Severe NASH With Advanced Liver Fibrosis in Non-severe Obese Patients
ClinicalTrials.gov ID: NCT03472157
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- For F4 fibrosis patients: 50\>BMI≥ 30kg/m² ; Fibroscan ≥ 15kPa predicting a F4 fibrosis score grade within 1 month before inclusion or F4 fibrosis...
- 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...
You likely can't join if
- 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...
- Being processed Cancer (chemotherapy, radiotherapy or hormone therapy)
See the full eligibility 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...
- 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...
- 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...
- 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...
- Patient agrees to come to the study visits within the protocol-specified delay
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lille, France
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lille, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.