An interventional study of Surgical procedure in Obesity, sponsored by University Hospital, Rouen. Completed at 1 site in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by University Hospital, Rouen · Not applicable, Interventional, and Basic science
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 255 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.
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Exclusion Criteria:
Procedure: Surgical procedure
Surgical procedure, liver biopsy, histopathological examination, laboratory tests
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
Time frame: 1 year after surgery
improvement in fibrosis scores (fibrotest, nashtest, steatotest)
We will measure the modifications of fibrosis scores, one year after surgery, to assess the effect of weight loss on liver fibrosis
Time frame: 1 year after surgery
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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University Hospital, Rouen