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

Cystic Fibrosis Clinical Trial

— PEDISCAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072721
• Other study ID #: P081207
• Secondary ID: 2009-A00738-49
• Status: Completed
• Phase: N/A
• Start date: January 19, 2010
• Est. completion date: April 30, 2018

Study information

• Verified date: June 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: April 30, 2018
• Est. primary completion date: July 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholestasis
• Cholestasis of Parenteral Nutrition
• Cirrhosis
• Cystic Fibrosis
• Fibrosis
• Hypertension, Portal
• Liver Cirrhosis
• Liver Fibrosis
• Portal Hypertension

Intervention

Other:
• Elastometry
Fibrosis detection with FIBROSCANN

Locations

Country	Name	City	State
France	Necker Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (4)

Castéra L, Vergniol J, Foucher J, Le Bail B, Chanteloup E, Haaser M, Darriet M, Couzigou P, De Lédinghen V. Prospective comparison of transient elastography, Fibrotest, APRI, and liver biopsy for the assessment of fibrosis in chronic hepatitis C. Gastroen — View Citation

Corpechot C, El Naggar A, Poujol-Robert A, Ziol M, Wendum D, Chazouillères O, de Lédinghen V, Dhumeaux D, Marcellin P, Beaugrand M, Poupon R. Assessment of biliary fibrosis by transient elastography in patients with PBC and PSC. Hepatology. 2006 May;43(5) — View Citation

de Lédinghen V, Le Bail B, Rebouissoux L, Fournier C, Foucher J, Miette V, Castéra L, Sandrin L, Merrouche W, Lavrand F, Lamireau T. Liver stiffness measurement in children using FibroScan: feasibility study and comparison with Fibrotest, aspartate transa — View Citation

Ganne-Carrié N, Ziol M, de Ledinghen V, Douvin C, Marcellin P, Castera L, Dhumeaux D, Trinchet JC, Beaugrand M. Accuracy of liver stiffness measurement for the diagnosis of cirrhosis in patients with chronic liver diseases. Hepatology. 2006 Dec;44(6):1511 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	For a better estimation of the fibrosis degree, after measuring the global nature of the liver, by decreasing the sampling bias.		two months
Secondary	For a best follow-up of the fibrosis to optimize the treatment.		two months