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

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.

Completed

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Key information

Conditions

Steatosis Body Weight Digestive System Diseases Fatty Liver Fibrosis Fibrosis, Liver Liver Cirrhosis Liver Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

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

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

Primary outcomes

Elasticity measured with the Fibroscan XL

Time frame: 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 outcomes

53/5000 Evolution of elasticity after bariatric surgery

Time frame: 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.

Sponsors and collaborators

Lead sponsor

European Georges Pompidou Hospital

Other

Collaborators

Echosens

Registry information

Official study 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

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2016
First posted: Jun 7, 2018
Registry last updated: Jun 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed