NCT01072721|Completed
Non Invasive Study of the Hepatic Fibrosis in Paediatrics by the Method of Study of Pediatric Hepatic Fibrosis
PEDISCAN
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PEDISCAN
Sponsor study identifier
Secondary identifiers
OTHER · AFSSAPS
interventional
264
1 country
1
Study Start
January 19, 2010
Actual (reported)Primary Completion
July 11, 2017
Actual (reported)Study Completion
April 30, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 19, 2010
Actual (reported)February 19, 2010
Actual (reported)February 22, 2010
Actual (reported)July 11, 2017
Actual (reported)April 30, 2018
Actual (reported)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
For a better estimation of the fibrosis degree, after measuring the global nature of the liver, by decreasing the sampling bias.
two months
For a best follow-up of the fibrosis to optimize the treatment.
two months
a single arm with the two interventions (elastometry and biopsy)
Fibrosis detection with FIBROSCANN
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Necker Hospital
Paris, 75015, France
Corpechot C, El Naggar A, Poujol-Robert A, Ziol M, Wendum D, Chazouilleres O, de Ledinghen 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):1118-24. doi: 10.1002/hep.21151.
Castera L, Vergniol J, Foucher J, Le Bail B, Chanteloup E, Haaser M, Darriet M, Couzigou P, De Ledinghen V. Prospective comparison of transient elastography, Fibrotest, APRI, and liver biopsy for the assessment of fibrosis in chronic hepatitis C. Gastroenterology. 2005 Feb;128(2):343-50. doi: 10.1053/j.gastro.2004.11.018.
Florence Lacaille, MD, PhD
Assistance Publique - Hôpitaux de Paris
264 participants (actual enrollment reported by the registry).
First Submitted
February 19, 2010
First Posted
February 22, 2010
Study Start
January 19, 2010
Actual (reported)Contact the study team to confirm eligibility.
Ganne-Carrie 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):1511-7. doi: 10.1002/hep.21420.
de Ledinghen V, Le Bail B, Rebouissoux L, Fournier C, Foucher J, Miette V, Castera L, Sandrin L, Merrouche W, Lavrand F, Lamireau T. Liver stiffness measurement in children using FibroScan: feasibility study and comparison with Fibrotest, aspartate transaminase to platelets ratio index, and liver biopsy. J Pediatr Gastroenterol Nutr. 2007 Oct;45(4):443-50. doi: 10.1097/MPG.0b013e31812e56ff.
Primary Completion
July 11, 2017
Actual (reported)Study Completion
April 30, 2018
Actual (reported)Last Updated
November 20, 2025
Record last verified: 2025-10
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Source: ClinicalTrials.gov.
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