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

NCT ID: NCT02041780

Last Updated: 2016-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-05-31

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.

Conditions

Liver Fibrosis; Children

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Shearwave electrography

Intervention Type: PROCEDURE

Interventions

Shearwave electrography

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

-

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stéphanie FRANCHI-ABELA, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

AP-HP, Bicêtre Hospital

Le Kremlin-Bicêtre, , France

Countries

France

Other Identifiers

P120128

Identifier Type: -

Identifier Source: org_study_id