Evaluation of the Diagnostic of Hepatic Fibrosis With the in Severe Obese Patients Candidates to Bariatric Surgery
June 6, 2018 updated by: Charles Barsamian, European Georges Pompidou Hospital
Evaluation of the Diagnostic of Hepatic Fibrosis With the XL Probe of the Fibroscan Versus Biopsies 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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
132
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Severe obese patients candidate to bariatric surgery
Description
Inclusion Criteria:
- Severe obese patients candidate to bariatric surgery with no history of liver disease have a large prevalence of liver lesions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 4, 2012
Primary Completion (Actual)
January 12, 2015
Study Completion (Actual)
December 6, 2016
Study Registration Dates
First Submitted
May 24, 2018
First Submitted That Met QC Criteria
June 6, 2018
First Posted (Actual)
June 7, 2018
Study Record Updates
Last Update Posted (Actual)
June 7, 2018
Last Update Submitted That Met QC Criteria
June 6, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B047
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.