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Completed

NCT Number: NCT01072721

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elastometry

Other

Fibrosis detection with FIBROSCANN

Primary outcomes

  1. 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 outcomes

  1. 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

  2. For a best follow-up of the fibrosis to optimize the treatment.

    Time frame: two months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: PEDISCAN

Important dates

Study start
2010
Primary completion
2017
Study completion
2018
First posted
Feb 22, 2010
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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