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

Primary Purpose

Cirrhosis, Liver Fibrosis, Portal Hypertension

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Elastometry
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cirrhosis focused on measuring Liver, Fibrosis, Elastometry, FIBROSCANN, Children

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Necker Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Fibrosis group

Arm Description

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

Outcomes

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.

Secondary Outcome Measures

For a better estimation of the fibrosis degree, after measuring the global nature of the liver, by decreasing the sampling bias.
For a best follow-up of the fibrosis to optimize the treatment.

Full Information

First Posted
February 19, 2010
Last Updated
June 18, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01072721
Brief Title
Non Invasive Study of the Hepatic Fibrosis in Paediatrics by the Method of Study of Pediatric Hepatic Fibrosis
Acronym
PEDISCAN
Official Title
Non Invasive Study of the Hepatic Fibrosis in Paediatrics by the Method of FIBROSCANN.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 19, 2010 (Actual)
Primary Completion Date
July 11, 2017 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Liver Fibrosis, Portal Hypertension, Cystic Fibrosis, Cholestasis of Parenteral Nutrition
Keywords
Liver, Fibrosis, Elastometry, FIBROSCANN, Children

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
264 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fibrosis group
Arm Type
Other
Arm Description
a single arm with the two interventions (elastometry and biopsy)
Intervention Type
Other
Intervention Name(s)
Elastometry
Intervention Description
Fibrosis detection with FIBROSCANN
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
For a best follow-up of the fibrosis to optimize the treatment.
Time Frame
two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence Lacaille, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Necker Hospital
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
16628644
Citation
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.
Results Reference
result
PubMed Identifier
15685546
Citation
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.
Results Reference
result
PubMed Identifier
17133503
Citation
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.
Results Reference
result
PubMed Identifier
18030211
Citation
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.
Results Reference
result

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

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