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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Non Invasive Assessment of Liver Fibrosis in Children: Evaluation of Diagnostic Performances of ShearWave Elastography (SWE) and Fibrotest®/ Fibromax® by Comparison With Fibrosis Score on Liver Biopsy

Conditions
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Liver Fibrosis, Children

Intervention / Treatment
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* Procedure: Shearwave electrography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age < 18 years; indication to liver biopsy; informed consent of both parents and child if applicable; social insurance Exclusion Criteria: -

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shearwave electrography<br>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. | Procedure: Shearwave electrography<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver fibrosis evaluated by the ISHAK score and morphometric evaluation | Histology is the gold standard to evaluate liver fibrosis | up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver fibrosis evaluation : stiffness using SHEARWAVE elastography |  | up 1 month | 
| Liver fibrosis evaluation using Fibrotest (Fibromax) |  | up 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnostic, Liver fibrosis, Ishak score, Fibrotest, ShearWave elastography, Liver biopsies