NCT01072721

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 19, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 22, 2010

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

7.5 years

First QC Date

February 19, 2010

Last Update Submit

November 17, 2025

Conditions

CirrhosisLiver FibrosisPortal HypertensionCystic FibrosisCholestasis of Parenteral Nutrition

Keywords

LiverFibrosisElastometryFIBROSCANNChildren

Outcome Measures

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.

    until two months

Secondary Outcomes (2)

  • 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

Study Arms (1)

Fibrosis group

OTHER

a single arm with the two interventions (elastometry and biopsy)

Other: Elastometry

Interventions

ElastometryOTHER

Fibrosis detection with FIBROSCANN

Fibrosis group

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Children of less than 6 months and more than 18 years old.
  • Pregnant women.
  • No written informed consent
  • No social security

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necker Hospital

Paris, 75015, France

Location

Related Publications (4)

  • 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.

    PMID: 16628644RESULT

  • 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.

    PMID: 15685546RESULT

  • 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.

    PMID: 17133503RESULT

  • 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.

    PMID: 18030211RESULT

MeSH Terms

Conditions

FibrosisLiver CirrhosisHypertension, PortalCystic Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System DiseasesPancreatic DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Florence Lacaille, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2010

First Posted

February 22, 2010

Study Start

January 19, 2010

Primary Completion

July 11, 2017

Study Completion

April 30, 2018

Last Updated

November 20, 2025

Record last verified: 2025-10

Locations

FR(1)