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

Not Applicable

Completed

• Conditions: Cholestasis of Parenteral Nutrition; Cirrhosis; Liver Fibrosis; Portal Hypertension; Cystic Fibrosis
• Interventions: Other: Elastometry

• Registration Number: NCT01072721
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2010-01-19
• Study First Submitted: 2010-02-19
• Study First Submitted QC: 2010-02-19
• Study First Posted: 2010-02-22
• Primary Completion: 2017-07-11
• Study Completion: 2018-04-30
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fibrosis group	Elastometry	a single arm with the two interventions (elastometry and biopsy)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Necker Hospital; 🇫🇷 Paris, France