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Evaluation of the Diagnostic of Hepatic Fibrosis With the 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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03548597
Enrollment
132
Registered
2018-06-07
Start date
2012-04-04
Completion date
2016-12-06
Last updated
2018-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibrosis, Liver, Obesity, Steatosis

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.

Interventions

DEVICEEvaluation 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

Sponsors

Echosens
CollaboratorINDUSTRY
European Georges Pompidou Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Elasticity measured with the Fibroscan XL3 yearsLiver elasticity will be measured non-invasively with Fibroscan. As this is a non-invasive measure, no adverse effects are expected. No treatment planned.

Secondary

MeasureTime frameDescription
53/5000 Evolution of elasticity after bariatric surgery3 yearsThe evolution of elasticity will be measured non-invasively with fibroscan after bariatric surgery. NO adverse effects are expected in relation to this measure.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026