RecruitingNCT03472157NASHSURGUpdated Apr 22, 2026

A Randomized Controlled Study Evaluating Bariatric Surgery as a Treatment for Severe NASH With Advanced Liver Fibrosis in Non-severe Obese Patients

An interventional study of Lifestyle therapy and Bariatric surgery in Surgery, Obesity and NASH - Nonalcoholic Steatohepatitis, sponsored by University Hospital, Lille. Recruiting at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 100
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

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).

Conditions studied

Surgery
Obesity
NASH - Nonalcoholic Steatohepatitis
Cirrhosis

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Keywords

Gastric bypass
Sleeve gastrectomy
Lifestyle therapy
NASH
Advanced fibrosis
Cirrhosis

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 100 participants (estimated)

Study arms

Experimental
Bariatric surgery
Two different types of bariatric surgery can be proposed: laparoscopic Roux-en-Y Gastric Bypass or a Laparoscopic sleeve gastrectomy. Decision of the surgery type will be made according to surgical expertise, habits of investigation centers and the patient's desire. All patients receive nutritional support and therapeutic education adapted to recommendations bariatric surgery care.
Procedure: Bariatric surgery
Active comparator
Lifestyle therapy
The group will received the medical standard treatment defined as lifestyle therapy combining diet with increased physical activity (standard treatment, control) (figure 1, design of study).
Other: Lifestyle therapy

Interventions

OtherLifestyle therapy
Lifestyle habits (caloric intake and exercise) + pedometer
ProcedureBariatric surgery
Two different types of bariatric surgery can be proposed: laparoscopic Roux-en-Y Gastric Bypass or a Laparoscopic sleeve gastrectomy

What researchers measure

Primary outcomes

Rate of disappearance of NASH without worsening of fibrosis grade
Diagnosis of NASH on the liver biopsy
Time frame: at 60 weeks after randomization

Secondary outcomes

Change in the NAS (Nafld Activity Score) score
NAS is a histological score established on the liver biopsy. The NAS ranges form 0 to 8. 8 is associated with the highest severity.
Time frame: at 60 weeks after randomization
Percentage of patients achieving at least a 2 point improvement in the NAS (≥2 points) without worsening of fibrosis grade
NAS established on the liver biopsy
Time frame: at 60 weeks after randomization
Change in the Brunt fibrosis score,
Brunt fibrosis is a histological score ranges from 0 to 4. The Brunt fibrosis score is established on the liver biopsy. It is the recommended score for the evaluation of fibrosis in NASH and NAFLD. On the scale, "0" is an absence of fibrosis, whereas "4" matches with cirrhosis.
Time frame: at 60 weeks after randomization
Change in the Metavir score
METAVIR fibrosis score is established on the liver biopsy. METAVIR fibrosis is a histological score ranges from 0 to 4. This score is more discriminant than the Brunt score for the severe form of fibrosis that are included in this study.On the scale, "0" is an absence of fibrosis, whereas "4" matches with cirrhosis.
Time frame: at 60 weeks after randomization
Change in the fibrosis area
computerized morphometry analysis of fibrosis area
Time frame: at 60 weeks after randomization
Change in the SF-36 quality of life score.
SF-36 quality of life score
Time frame: at 60 weeks after randomization
Percentage of patients with at least one of the following complications
complications: infection, thromboembolic complications, haemorrhage, rhabdomyolysis, hepatic decompensation and death
Time frame: through study completion
Percentage of patient achieving 5 and 10% of weight loss from randomization to end of treatment.
Weight
Time frame: at 60 weeks after randomization
Change in aspartate transaminase (AST)
AST is a liver enzyme, used for the biological liver test evaluation.
Time frame: at 60 weeks after randomization
Change in Alanine transaminase (ALT)
ALT is a liver enzyme, used for the biological liver test evaluation.
Time frame: at 60 weeks after randomization
Change in total bilirubin
Total bilirubin is a liver enzyme, used for the biological liver test evaluation.
Time frame: at 60 weeks after randomization
Change in GGT
GGT (gamma glutamyl transferase) is a liver enzyme, used for the biological liver test evaluation. .
Time frame: at 60 weeks after randomization
Change in ALP
Alkalin Phosphatase is a liver enzyme, used for the biological liver test evaluation.
Time frame: at 60 weeks after randomization
Change in INR (International Normalized Ratio)
INR represents coagulation but also liver hepatocellular function.
Time frame: at 60 weeks after randomization
Change in Albumin
Albumin is used a marker of nutrition and hepatocellular function
Time frame: at 60 weeks after randomization
Change in metabolic profile assessed by HOMA score
HOMA is a score (scale) evaluating insulin resistance.
Time frame: at 60 weeks after randomization
Change in Fasting glucose
fasting glucose is a marker of diabetes and insulin resistance
Time frame: at 60 weeks after randomization
Change in Glycated haemoglobin
glycated haemoglobin is a surrogate marker for diabetes management and outcome.
Time frame: at 60 weeks after randomization
Change in HDL cholesterol
HDL cholesterol is a biomarker for lipid metabolism and cardiovascular risk
Time frame: at 60 weeks after randomization
Change in serum triglycerides
serum triglycerides is a biomarker for lipid metabolism and cardiovascular risk
Time frame: at 60 weeks after randomization
Change in LDL cholesterol
LDL cholesterol is a biomarker for lipid metabolism and cardiovascular risk
Time frame: at 60 weeks after randomization
Change in total cholesterol.
total cholesterol is a biomarker for lipid metabolism and cardiovascular risk
Time frame: at 60 weeks after randomization

Study locations

1 of 1 sites recruiting

Hôpital Claude Huriez, CHRU
Lille, France
- Guillaume Lassailly, MD · Principal investigator
Recruiting

Registry details

Key details

Study ID: NCT03472157
Lead sponsor: University Hospital, Lille
Collaborators: Ministry of Health, France
Responsible party: Sponsor
First posted: Mar 21, 2018
Start date: Jun 20, 2018
Primary completion: Jun 20, 2028 (estimated)
Completion: Jun 20, 2028 (estimated)
Last update: Apr 22, 2026

Study contacts

Philippe Mathurin, MD,PhD

Contact

philippe.mathurin@chru-lille.fr

3 20 44 53 21 ext. +33

Guillaume Lassailly, MD

Contact

guillaume.lassailly@chru-lille.fr

3 20 44 53 21 ext. +33

Philippe Mathurin, MD,PhD

principal investigator · University Hospital, Lille

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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