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
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Fibrosis
• Fibrosis, Liver
• Liver Cirrhosis
• Obesity
• Steatosis

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