Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Evaluation of Liver Fibrosis Following Surgical-induced Weight Loss (FIBROTEST)

This study has been completed.
University Hospital, Lille
Amiens University Hospital
Information provided by (Responsible Party):
University Hospital, Rouen Identifier:
First received: November 5, 2011
Last updated: June 18, 2014
Last verified: June 2014

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.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evolution of Fibrosis Scores During Weight Loss in a Population of Patients Operated on for Morbid Obesity

Resource links provided by NLM:

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Improvement in transthyretin serum levels [ Time Frame: 1 year after surgery ]
    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

Secondary Outcome Measures:
  • improvement in fibrosis scores (fibrotest, nashtest, steatotest) [ Time Frame: 1 year after surgery ]
    We will measure the modifications of fibrosis scores, one year after surgery, to assess the effect of weight loss on liver fibrosis

Enrollment: 255
Study Start Date: November 2011
Study Completion Date: February 2014
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
obese patients


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
obese patients

Inclusion Criteria:

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

Exclusion Criteria:

  • contraindications to morbid obesity surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01469962

Rouen University Hospital
Rouen, France, 76000
Sponsors and Collaborators
University Hospital, Rouen
University Hospital, Lille
Amiens University Hospital
  More Information

Responsible Party: University Hospital, Rouen Identifier: NCT01469962     History of Changes
Other Study ID Numbers: 2010/079/HP
Study First Received: November 5, 2011
Last Updated: June 18, 2014

Keywords provided by University Hospital, Rouen:
morbid obesity
bariatric surgery
Liver fibrosis

Additional relevant MeSH terms:
Weight Loss
Nutrition Disorders
Body Weight
Signs and Symptoms
Pathologic Processes
Body Weight Changes processed this record on May 25, 2017