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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Children; Liver Fibrosis

Treatments: Procedure: Shearwave electrography

Study type: Interventional

Funder types: Other

Identifiers

NCT02041780

P120128

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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220 participants in 1 patient group

Shearwave electrography

Experimental group

Description:

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.

Treatment:

Procedure: Shearwave electrography