NCT03548597

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2015

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 7, 2018

Completed
Last Updated

June 7, 2018

Status Verified

June 1, 2018

Enrollment Period

2.8 years

First QC Date

May 24, 2018

Last Update Submit

June 6, 2018

Conditions

SteatosisObesityFibrosis, Liver

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 53/5000 Evolution of elasticity after bariatric surgery

    3 years

Interventions

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

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Severe obese patients candidate to bariatric surgery

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Barsamian C, Carette C, Sasso M, Poghosyan T, Bedossa P, Emile JF, Parlier D, Miette V, Bouillot JL, Czernichow S, Rives-Lange C. Diagnostic of hepatic fibrosis with the XL probe of the Fibroscan versus biopsies in patients candidates to bariatric surgery. Clin Nutr ESPEN. 2020 Jun;37:226-232. doi: 10.1016/j.clnesp.2020.02.010. Epub 2020 Mar 12.

    PMID: 32359748DERIVED

MeSH Terms

Conditions

Fatty LiverObesityLiver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFibrosisPathologic Processes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Medicine

Study Record Dates

First Submitted

May 24, 2018

First Posted

June 7, 2018

Study Start

April 4, 2012

Primary Completion

January 12, 2015

Study Completion

December 6, 2016

Last Updated

June 7, 2018

Record last verified: 2018-06