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Evaluation of Liver Fibrosis Following Surgical-induced Weight Loss

Evolution of Fibrosis Scores During Weight Loss in a Population of Patients Operated on for Morbid Obesity

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01469962
Acronym
FIBROTEST
Enrollment
255
Registered
2011-11-10
Start date
2011-11-01
Completion date
2014-02-01
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

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

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.

Interventions

PROCEDURESurgical procedure

Surgical procedure, liver biopsy, histopathological examination, laboratory tests

Sponsors

University Hospital, Rouen
Lead SponsorOTHER
University Hospital, Lille
CollaboratorOTHER
Amiens University Hospital
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* contraindications to morbid obesity surgery

Design outcomes

Primary

MeasureTime frameDescription
Improvement in transthyretin serum levels1 year after surgeryWe 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

MeasureTime frameDescription
improvement in fibrosis scores (fibrotest, nashtest, steatotest)1 year after surgeryWe will measure the modifications of fibrosis scores, one year after surgery, to assess the effect of weight loss on liver fibrosis

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026