Evaluation of Liver Fibrosis Following Surgical-induced Weight Loss

NCT01469962 | Completed DMC

• 1 other identifier: 2010/079/HP
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is a frequent disease with an increased prevalence, estimated to 12.4% in France (OBEPI study 2006). Non alcoholic fatty liver disease (NAFLD) and non alcoholic steatohepatitis (NASH) both complicate morbid obesity and could be responsible for the development of liver fibrosis and consequently of liver cirrhosis. Bariatric surgery has been widely used in obese patients to reduce their weight but also to decrease morbidity conditions related to obesity. It could be involved in an improvement in liver lesions observed in obese patients. To evaluate the severity of liver lesions, the gold standard is pathological examination of the liver using percutaneous or surgical biopsies, with a scoring called Fibrosis score stage. Alternative less invasive techniques have been developed to evaluate liver lesions. These tests are commonly used in clinical hepatology and consisted of serum levels determination of fibrosis markers (Fibrotest, Transthyretin). The aim of this study is to evaluate the evolution of fibrosis scores during weight loss in a population of patients operated on for morbid obesity ( BMI \> 40kg/m2 or BMI\> 35kg/m2 with comorbidity). The primary end point is to evaluate the concordance between Fibrotest and transthyretin serum levels. The number of patients has been calculated on the basis of a concordance ( Kendall test) superior to 70% in patients with grade F1 fibrosis that represents about 40% of morbid obese patients. A total of 255 patients has to be enrolled in this study. According to the number of patients operated on in the 3 centres (\>150/year), the time for recruitment is 12 months. Secondary end points will evaluate in these patients the excess weight loss, the improvement in fibrosis liver tests and the correlation with improvement in other obesity- related conditions, according to surgical procedures.

Conditions

Obesity

Keywords

morbid obesity; bariatric surgery; NASH; Liver fibrosis; Fibrotest

Outcome Measures

Primary Outcomes (1)

• Improvement in transthyretin serum levels

  We will measure the modifications of Transthyretin serum levels in correlation with fibrotest, one year after surgery, to assess the effect of weight loss on liver fibrosis

  1 year after surgery

Secondary Outcomes (1)

• improvement in fibrosis scores (fibrotest, nashtest, steatotest)

  1 year after surgery

Study Arms (1)

obese patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

obese patients

You may qualify if:

• patients operated on for morbid obesity (BMI \>40kg/m2 or \>35kg/m2 associated with comorbidity)

You may not qualify if:

• contraindications to morbid obesity surgery

Sponsors & Collaborators

• University Hospital, Rouen: lead
• University Hospital, Lille: collaborator
• Amiens University Hospital: collaborator

Study Sites (1)

Rouen University Hospital

Rouen, 76000, France

Location

Related Publications (1)

• Codjia T, Rebibo L, Francois A, Lagnel C, Huet E, Bekri S, Pattou F, Regimbeau JM, Schwarz L. Evolution of Non-alcoholic Fatty Liver Disease (NAFLD) Biomarkers in Response to Weight Loss 1 Year After Bariatric Surgery-a Post Hoc Analysis of the FibroTest Prospective Study. Obes Surg. 2021 Aug;31(8):3548-3556. doi: 10.1007/s11695-021-05402-0. Epub 2021 Apr 12.

  PMID: 33844174 RESULT

MeSH Terms

Conditions

Obesity; Obesity, Morbid; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2011
• First Posted: November 10, 2011
• Study Start: November 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2014
• Last Updated: May 18, 2026

Record last verified: 2014-06

Locations

FR (1)