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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01072721
First Posted: February 22, 2010
Last Update Posted: June 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
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 ]

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 ]
  • For a best follow-up of the fibrosis to optimize the treatment. [ Time Frame: two months ]

Enrollment: 264
Study Start Date: January 2010
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (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

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

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01072721


Locations
France
Necker Hospital
Paris, France, 75015
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 ( Other Identifier: AFSSAPS )
First Submitted: February 19, 2010
First Posted: February 22, 2010
Last Update Posted: June 24, 2016
Last Verified: June 2016

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

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Hypertension, Portal
Liver Cirrhosis
Cholestasis
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