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
  Purpose

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.


Condition Intervention
Cirrhosis
Liver Fibrosis
Portal Hypertension
Cystic Fibrosis
Cholestasis of Parenteral Nutrition
Other: Elastometry

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Non Invasive Study of the Hepatic Fibrosis in Paediatrics by the Method of FIBROSCANN.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: January 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Fibrosis group
a single arm with the two interventions (elastometry and biopsy)
Other: Elastometry
Fibrosis detection with FIBROSCANN
Other Name: Elastometry

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.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072721

Contacts
Contact: Muriel Girard, MD, PhD 0033144494226 muriel.girard@nck.aphp.fr
Contact: Laurence Lecomte, PhD 0033158413545 laurence.lecomte@cch.aphp.fr

Locations
France
Necker Hospital Recruiting
Paris, France, 75015
Principal Investigator: Florence Lacaille, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Florence Lacaille, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01072721     History of Changes
Other Study ID Numbers: P081207, 2009-A00738-49
Study First Received: February 19, 2010
Last Updated: January 2, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Liver
Fibrosis
Elastometry
FIBROSCANN
Children

Additional relevant MeSH terms:
Hypertension
Fibrosis
Cystic Fibrosis
Hypertension, Portal
Cholestasis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Liver Diseases
Bile Duct Diseases
Biliary Tract Diseases

ClinicalTrials.gov processed this record on October 19, 2014