Children, Liver Fibrosis
Conditions
Keywords
Diagnostic, Liver fibrosis, Ishak score, Fibrotest, ShearWave elastography, Liver biopsies
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.
Interventions
PROCEDUREShearwave electrography
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* age \< 18 years; * indication to liver biopsy; * informed consent of both parents and child if applicable; * social insurance
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| liver fibrosis evaluated by the ISHAK score and morphometric evaluation | up to 1 month | Histology is the gold standard to evaluate liver fibrosis |
Secondary
| Measure | Time frame |
|---|---|
| liver fibrosis evaluation : stiffness using SHEARWAVE elastography | up 1 month |
| Liver fibrosis evaluation using Fibrotest (Fibromax) | up 1 month |
Countries
France
Outcome results
None listed