SurgeryNASHSURGNCT03472157
A Randomized Controlled Study Evaluating Bariatric Surgery as a Treatment for Severe NASH With Advanced Liver Fibrosis in Non-severe Obese Patients
A study testing Lifestyle therapy and Bariatric surgery in people with Surgery and Obesity, run by University Hospital, Lille at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Surgery, Obesity, NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- Lifestyle therapy and Bariatric surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2018to 20 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Claude Huriez, CHRU
Lille
Guillaume Lassailly, MD
About this study
Official title: Prospective Multicentric, Open Label, Randomized Clinical Trial of Superiority, With Two Arms, Comparing Bariatric Surgery to the Recommended Medical Treatment for NASH
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
- Surgery, Obesity, NASH - Nonalcoholic Steatohepatitis, Cirrhosis
- Being tested
- Lifestyle therapy, Bariatric surgery
- Keywords
- Gastric bypass, Sleeve gastrectomy, Lifestyle therapy, NASH, Advanced fibrosis, Cirrhosis
- Medical subject headings
- Obesity, Non-alcoholic Fatty Liver Disease, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle therapyOther
Lifestyle habits (caloric intake and exercise) + pedometer
Bariatric surgeryProcedure or surgery
Two different types of bariatric surgery can be proposed: laparoscopic Roux-en-Y Gastric Bypass or a Laparoscopic sleeve gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery | Experimental | 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. Receives: Procedure: Bariatric surgery |
| Lifestyle therapy | Active comparator | 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). Receives: Other: Lifestyle therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of disappearance of NASH without worsening of fibrosis grade
Diagnosis of NASH on the liver biopsy
Measured: at 60 weeks after randomization
Secondary outcomes (22)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: at 60 weeks after randomization
Change in the fibrosis area
computerized morphometry analysis of fibrosis area
Measured: at 60 weeks after randomization
Change in the SF-36 quality of life score.
SF-36 quality of life score
Measured: 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
Measured: through study completion
Percentage of patient achieving 5 and 10% of weight loss from randomization to end of treatment.
Weight
Measured: at 60 weeks after randomization
Change in aspartate transaminase (AST)
AST is a liver enzyme, used for the biological liver test evaluation.
Measured: at 60 weeks after randomization
Change in Alanine transaminase (ALT)
ALT is a liver enzyme, used for the biological liver test evaluation.
Measured: at 60 weeks after randomization
Change in total bilirubin
Total bilirubin is a liver enzyme, used for the biological liver test evaluation.
Measured: at 60 weeks after randomization
Change in GGT
GGT (gamma glutamyl transferase) is a liver enzyme, used for the biological liver test evaluation. .
Measured: at 60 weeks after randomization
Change in ALP
Alkalin Phosphatase is a liver enzyme, used for the biological liver test evaluation.
Measured: at 60 weeks after randomization
Change in INR (International Normalized Ratio)
INR represents coagulation but also liver hepatocellular function.
Measured: at 60 weeks after randomization
Change in Albumin
Albumin is used a marker of nutrition and hepatocellular function
Measured: at 60 weeks after randomization
Change in metabolic profile assessed by HOMA score
HOMA is a score (scale) evaluating insulin resistance.
Measured: at 60 weeks after randomization
Change in Fasting glucose
fasting glucose is a marker of diabetes and insulin resistance
Measured: at 60 weeks after randomization
Change in Glycated haemoglobin
glycated haemoglobin is a surrogate marker for diabetes management and outcome.
Measured: at 60 weeks after randomization
Change in HDL cholesterol
HDL cholesterol is a biomarker for lipid metabolism and cardiovascular risk
Measured: at 60 weeks after randomization
Change in serum triglycerides
serum triglycerides is a biomarker for lipid metabolism and cardiovascular risk
Measured: at 60 weeks after randomization
Change in LDL cholesterol
LDL cholesterol is a biomarker for lipid metabolism and cardiovascular risk
Measured: at 60 weeks after randomization
Change in total cholesterol.
total cholesterol is a biomarker for lipid metabolism and cardiovascular risk
Measured: at 60 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start20 Jun 2018
- Primary completion20 Jun 2028 (estimated)
- Study completion20 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Philippe Mathurin, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472157
- Sponsor's protocol ID
- 2016_78
- Other IDs
- 2017-A01575-48
- Acronym
- NASHSURG
- Status last verified
- Apr 2026
- First submitted
- 13 Feb 2018
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentric, Open Label, Randomized Clinical Trial of Superiority, With Two Arms, Comparing Bariatric Surgery to the Recommended Medical Treatment for NASH
- ClinicalTrials.gov ID
- NCT03472157
- Acronym / sponsor ID
- NASHSURG / 2016_78
- Conditions
- Surgery, Obesity, NASH - Nonalcoholic Steatohepatitis, Cirrhosis
- Keywords
- Gastric bypass, Sleeve gastrectomy, Lifestyle therapy, NASH, Advanced fibrosis, Cirrhosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 20 Jun 2028 (estimated)
- Study completion
- 20 Jun 2028 (estimated)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery | Experimental | Procedure: Bariatric surgeryTwo 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. |
| Lifestyle therapy | Active comparator | Other: Lifestyle therapyThe 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provide written informed consent and agree to comply to the study protocol prior to enrolment.
- BMI and Brunt Fibriosis score:
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle therapyLifestyle habits (caloric intake and exercise) + pedometer | Other | Lifestyle therapy |
| Bariatric surgeryTwo different types of bariatric surgery can be proposed: laparoscopic Roux-en-Y Gastric Bypass or a Laparoscopic sleeve gastrectomy | Procedure or surgery | Bariatric surgery |
Primary outcome
Rate of disappearance of NASH without worsening of fibrosis grade
Time frame: at 60 weeks after randomization
Diagnosis of NASH on the liver biopsy
22 secondary outcomes
Change in the NAS (Nafld Activity Score) score
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
Time frame: at 60 weeks after randomization
Change in the Brunt fibrosis score,
Time frame: at 60 weeks after randomization
Change in the Metavir score
Time frame: at 60 weeks after randomization
Change in the fibrosis area
Time frame: at 60 weeks after randomization
Change in the SF-36 quality of life score.
Time frame: at 60 weeks after randomization
Percentage of patients with at least one of the following complications
Time frame: through study completion
Percentage of patient achieving 5 and 10% of weight loss from randomization to end of treatment.
Time frame: at 60 weeks after randomization
Change in aspartate transaminase (AST)
Time frame: at 60 weeks after randomization
Change in Alanine transaminase (ALT)
Time frame: at 60 weeks after randomization
Change in total bilirubin
Time frame: at 60 weeks after randomization
Change in GGT
Time frame: at 60 weeks after randomization
Change in ALP
Time frame: at 60 weeks after randomization
Change in INR (International Normalized Ratio)
Time frame: at 60 weeks after randomization
Change in Albumin
Time frame: at 60 weeks after randomization
Change in metabolic profile assessed by HOMA score
Time frame: at 60 weeks after randomization
Change in Fasting glucose
Time frame: at 60 weeks after randomization
Change in Glycated haemoglobin
Time frame: at 60 weeks after randomization
Change in HDL cholesterol
Time frame: at 60 weeks after randomization
Change in serum triglycerides
Time frame: at 60 weeks after randomization
Change in LDL cholesterol
Time frame: at 60 weeks after randomization
Change in total cholesterol.
Time frame: at 60 weeks after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
Related trials for Surgery
Not yet recruiting
The Contribution of Accelerated Recovery (mERAS) Approach to Postoperative Recovery in Pediatric Laparoscopic Surgery Cases
mERAS Intervention, The ASA (American Society of Anesthesiologists) Score
RecruitingObservational study
Label-free Femtosecond Laser Imaging Combined With the Fast Lung Artificial Intelligence Model for Rapid Intraoperative Diagnosis of Lung Surgical Specimens: A Multicentre, Prospective, Parallel-workflow, Non-inferiority Study.
Lung Cancer
RecruitingPhase 3
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
Ganglioneuroblastoma, Nodular, Neuroblastoma
Not yet recruiting
The Effect of Compound Chamomile and Lidocaine Hydronchloride Gel as an Endotracheal Tube Lubricant on Postoperative Pharyngeal and Laryngeal Complications in Thoracic Surgery Patients
Postoperative Sore Throat
Active, not recruitingObservational study
Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Injury at C5-C7 Level
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philippe Mathurin, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle therapy and Bariatric surgery in people with Surgery and Obesity, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe Mathurin, MD,PhD (3 20 44 53 21 ext. +33, philippe.mathurin@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of disappearance of NASH without worsening of fibrosis grade (time frame: at 60 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.