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

This study is currently recruiting participants.
Verified December 2012 by University Hospital, Rouen
Sponsor:
Collaborators:
University Hospital, Lille
Amiens University Hospital
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01469962
First received: November 5, 2011
Last updated: December 21, 2012
Last verified: December 2012
  Purpose

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.


Condition
Obesity

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    We will measure the modifications of fibrosis scores, one year after surgery, to assess the effect of weight loss on liver fibrosis


Estimated Enrollment: 255
Study Start Date: November 2011
Estimated Study Completion Date: June 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
obese patients

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

obese patients

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469962

Contacts
Contact: Michel scotte, MD, PhD 33232886861 michel.scotte@chu-rouen.fr

Locations
France
Rouen University Hospital Recruiting
Rouen, France, 76000
Contact: michel scotte, md, phd    33232886861    michel.scotte@chu-rouen.fr   
Sub-Investigator: emmanuel huet, MD         
Sponsors and Collaborators
University Hospital, Rouen
University Hospital, Lille
Amiens University Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01469962     History of Changes
Other Study ID Numbers: 2010/079/HP
Study First Received: November 5, 2011
Last Updated: December 21, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Fibrosis
Obesity
Obesity, Morbid
Weight Loss
Liver Cirrhosis
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 15, 2014