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NCT03548597 Clinical Trial

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

Obesity Clinical Trial

Official title:
Evaluation of the Diagnostic of Hepatic Fibrosis With the XL Probe of the Fibroscan Versus Biopsies in Severe Obese Patients Candidates to Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03548597
Other study ID # B047
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 4, 2012
Est. completion date December 6, 2016

Study information
Verified date June 2018
Source European Georges Pompidou Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 132
Est. completion date December 6, 2016
Est. primary completion date January 12, 2015
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Evaluation of the Diagnostic of Hepatic Fibrosis With the XL Probe of the Fibroscan Versus Biopsies in Severe Obese Patients Candidates to Bariatric Surgery
Evaluation of the Diagnostic of Hepatic Fibrosis With the XL Probe of the Fibroscan Versus Biopsies in Severe Obese Patients Candidates to Bariatric Surgery

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
European Georges Pompidou Hospital Echosens

Outcome
Type Measure Description Time frame Safety issue
Primary Elasticity measured with the Fibroscan XL Liver elasticity will be measured non-invasively with Fibroscan. As this is a non-invasive measure, no adverse effects are expected. No treatment planned. 3 years
Secondary 53/5000 Evolution of elasticity after bariatric surgery The evolution of elasticity will be measured non-invasively with fibroscan after bariatric surgery. NO adverse effects are expected in relation to this measure. 3 years
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