Evaluation of the Diagnostic of Hepatic Fibrosis With the in Severe Obese Patients Candidates to Bariatric Surgery

Completed

• Conditions: Obesity; Fibrosis, Liver; Steatosis

• Registration Number: NCT03548597
• Lead Sponsor: European Georges Pompidou Hospital

Brief Summary

Background:

The XL probe of FibroScan was recently developed to realize liver stiffness measurements (LSM) in overweight patients.

Severe obese patients have a high prevalence of liver injuries and could benefit of liver evaluation prior to bariatric surgery.

Objectives:

Assess the FibroScan applicability, reliability and diagnostic performances in severe obese patients' candidates for bariatric surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-04
• Primary Completion: 2015-01-12
• Study Completion: 2016-12-06
• Study First Submitted: 2018-05-24
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-06
• Last Update Submitted: 2018-06-06
• Study First Posted: 2018-06-07
• Last Update Posted: 2018-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Severe obese patients candidate to bariatric surgery with no history of liver disease have a large prevalence of liver lesions.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Elasticity measured with the Fibroscan XL	3 years	Liver elasticity will be measured non-invasively with Fibroscan. As this is a non-invasive measure, no adverse effects are expected. No treatment planned.

Secondary Outcome Measures

Name	Time	Method
53/5000 Evolution of elasticity after bariatric surgery	3 years	The evolution of elasticity will be measured non-invasively with fibroscan after bariatric surgery. NO adverse effects are expected in relation to this measure.