Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01072721
First received: February 19, 2010
Last updated: January 2, 2014
Last verified: December 2013

February 19, 2010
January 2, 2014
January 2010
October 2014   (final data collection date for primary outcome measure)
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. [ Time Frame: until two months ] [ Designated as safety issue: No ]
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. [ Time Frame: until one month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01072721 on ClinicalTrials.gov Archive Site
  • For a better estimation of the fibrosis degree, after measuring the global nature of the liver, by decreasing the sampling bias. [ Time Frame: two months ] [ Designated as safety issue: No ]
  • For a best follow-up of the fibrosis to optimize the treatment. [ Time Frame: two months ] [ Designated as safety issue: No ]
  • For a better estimation of the fibrosis degree, after measuring the global nature of the liver, by decreasing the sampling bias. [ Time Frame: one month ] [ Designated as safety issue: No ]
  • For a best follow-up of the fibrosis to optimize the treatment. [ Time Frame: one month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Non Invasive Study of the Hepatic Fibrosis in Paediatrics by the Method of Study of Pediatric Hepatic Fibrosis
Non Invasive Study of the Hepatic Fibrosis in Paediatrics by the Method of FIBROSCANN.

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
  • Cirrhosis
  • Liver Fibrosis
  • Portal Hypertension
  • Cystic Fibrosis
  • Cholestasis of Parenteral Nutrition
Other: Elastometry
Fibrosis detection with FIBROSCANN
Other Name: Elastometry
Fibrosis group
a single arm with the two interventions (elastometry and biopsy)
Intervention: Other: Elastometry

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
March 2015
October 2014   (final data collection date for primary outcome measure)

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
Both
6 Months to 18 Years
No
Contact: Muriel Girard, MD, PhD 0033144494226 muriel.girard@nck.aphp.fr
Contact: Laurence Lecomte, PhD 0033158413545 laurence.lecomte@cch.aphp.fr
France
 
NCT01072721
P081207, 2009-A00738-49
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Florence Lacaille, MD, PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP