Non Invasive Study of the Hepatic Fibrosis in Paediatrics by the Method of Study of Pediatric Hepatic Fibrosis

Study Overview
=================
Brief Summary
-----------------
Early diagnosis of liver fibrosis is useful for the follow-up and treatment of chronic liver disease. At present, the unique validated method to evaluate the liver fibrosis in children, is the liver biopsy which is an invasive method. If the elastometry method is proved to be a good method to evaluate the fibrosis in children, a numerous liver biopsy could be avoided.

Detailed Description
-----------------
The elastometry method is proved to be efficient for the evaluation of liver fibrosis in adults. But the inter-costal space is too thin in children, and the adult probe could not be used. Recently a special probe adapted to the children have been TECHNICATED. We want to test this specific probe in children. Five French Paediatrics centres will participate to the study. We need 200 children inclusions in 2 years to have a statistically power analysis. Inclusion of each child will be in order to the need of a liver biopsy. Each children included will have an elastometry measure in the same time than the liver biopsy. The fibrosis will be staged by a trained pathologist and scored by METAVIR score witch is the reference. The elastometry measure will be realised by physician with 3 sequential measures in each child. The statistical analysis will be performed by statistician. If elastometry is proved to be an efficient method to evaluate the liver fibrosis in children, a numerous of liver biopsy could be avoided. Because elastometry is a non invasive method it could also be used as follow-up in different categories of children who needs sequential liver biopsy.

Official Title
-----------------
Non Invasive Study of the Hepatic Fibrosis in Paediatrics by the Method of FIBROSCANN.

Conditions
-----------------
Cirrhosis, Liver Fibrosis, Portal Hypertension, Cystic Fibrosis, Cholestasis of Parenteral Nutrition

Intervention / Treatment
-----------------
* Other: Elastometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : Children age more than 6 months and under 18 years old. Children with an hepatic biopsy for any fibrosis hepatitic diseases Clinical examination by a physician Exclusion criteria : Children of less than 6 months and more than 18 years old. Pregnant women. No written informed consent No social security

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fibrosis group<br>a single arm with the two interventions (elastometry and biopsy) | Other: Elastometry<br>* Fibrosis detection with FIBROSCANN<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the diagnosis value of hepatic elasticity measured by FIBROSCANN ® about fibrosis degree in comparison with hepatic biopsy (GOLDSTANDART) in a paediatric hepatic diseases cohort. |  | until two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For a better estimation of the fibrosis degree, after measuring the global nature of the liver, by decreasing the sampling bias. |  | two months | 
| For a best follow-up of the fibrosis to optimize the treatment. |  | two months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver, Fibrosis, Elastometry, FIBROSCANN, Children