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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Portal Hypertension; Cirrhosis; Cholestasis of Parenteral Nutrition; Liver Fibrosis; Cystic Fibrosis

Treatments: Other: Elastometry

Study type: Interventional

Funder types: Other

Identifiers

NCT01072721

P081207

2009-A00738-49 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 264 patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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264 participants in 1 patient group

Fibrosis group

Other group

Description:

a single arm with the two interventions (elastometry and biopsy)

Treatment:

Other: Elastometry