Non Invasive Assessment of Liver Fibrosis in Children: Comparison of ShearWave Elastography, Fibrotest and Liver Biopsy

Not Applicable

Completed

• Conditions: Children; Liver Fibrosis
• Interventions: Procedure: Shearwave electrography

• Registration Number: NCT02041780
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The purpose of this study is to determine if SWE and Fibrotest®/ Fibromax®, alone or associated, are effective methods to assess liver fibrosis in children.

Detailed Description

Liver biopsy will be the gold standard to assess fibrosis using Ishak score and morphometric evaluation of fibrosis. All children included will have a measure of liver stiffness using SWE with 5 measures performed in the area where the biopsy is performed and 5 measures in an other place in the liver. Fibrotest®/ Fibromax® will be performed on blood sample. All exams will be done within 1 month. diagnostic performance of SWE and Fibrotest®/ Fibromax® will be assessed respectively. algorithm using the results of both technics will be tested in order to test diagnostic performance and to obtain better performances.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-01-20
• Study First Submitted QC: 2014-01-20
• Study First Posted: 2014-01-22
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-28
• Last Update Posted: 2016-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• age < 18 years;
• indication to liver biopsy;
• informed consent of both parents and child if applicable;
• social insurance

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Shearwave electrography	Shearwave electrography	Two experimental interventions will be realized in each patient in this population : Shearwave electrography (new diagnostic test of fibrosis) and Fibrotest . Moreover, liver biopsies, the gold standard for the fibrosis diagnosis is also realized in each patient within usual cares.

Primary Outcome Measures

Name	Time	Method
liver fibrosis evaluated by the ISHAK score and morphometric evaluation	up to 1 month	Histology is the gold standard to evaluate liver fibrosis

Secondary Outcome Measures

Name	Time	Method
liver fibrosis evaluation : stiffness using SHEARWAVE elastography	up 1 month
Liver fibrosis evaluation using Fibrotest (Fibromax)	up 1 month

Trial Locations

Locations (1)

AP-HP, Bicêtre Hospital; 🇫🇷 Le Kremlin-Bicêtre, France