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

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ClinicalTrials.gov Identifier: NCT03548597
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Sponsor:
Collaborator:
Echosens
Information provided by (Responsible Party):
Charles Barsamian, 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.


Condition or disease Intervention/treatment
Steatosis Obesity Fibrosis, Liver 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

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Study Type : Observational
Actual Enrollment : 132 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 4, 2012
Actual Primary Completion Date : January 12, 2015
Actual Study Completion Date : December 6, 2016



Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Severe obese patients candidate to bariatric surgery
Criteria

Inclusion Criteria:

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

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Responsible Party: Charles Barsamian, Doctor of Medicine, European Georges Pompidou Hospital
ClinicalTrials.gov Identifier: NCT03548597     History of Changes
Other Study ID Numbers: B047
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases