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Non Invasive Assessment of Liver Fibrosis in Children: Comparison of ShearWave Elastography, Fibrotest and Liver Biopsy (SHEARWAVE)

Primary Purpose

Liver Fibrosis, Children

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

About this trial

This is an interventional diagnostic trial for Liver Fibrosis focused on measuring Diagnostic, Liver fibrosis, Ishak score, Fibrotest, ShearWave elastography, Liver biopsies

Eligibility Criteria

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

Inclusion Criteria:

  • age < 18 years;
  • indication to liver biopsy;
  • informed consent of both parents and child if applicable;
  • social insurance

Exclusion Criteria:

-

Sites / Locations

  • AP-HP, Bicêtre Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Shearwave electrography

Arm Description

Two experimental interventions will be realized in each patient in this population : Shearwave electrography (new diagnostic test of fibrosis) and Fibrotest . Moreover, liver biopsies, the gold standard for the fibrosis diagnosis is also realized in each patient within usual cares.

Outcomes

Primary Outcome Measures

liver fibrosis evaluated by the ISHAK score and morphometric evaluation
Histology is the gold standard to evaluate liver fibrosis

Secondary Outcome Measures

liver fibrosis evaluation : stiffness using SHEARWAVE elastography
Liver fibrosis evaluation using Fibrotest (Fibromax)

Full Information

First Posted
January 20, 2014
Last Updated
September 28, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02041780
Brief Title
Non Invasive Assessment of Liver Fibrosis in Children: Comparison of ShearWave Elastography, Fibrotest and Liver Biopsy
Acronym
SHEARWAVE
Official Title
Non Invasive Assessment of Liver Fibrosis in Children: Evaluation of Diagnostic Performances of ShearWave Elastography (SWE) and Fibrotest®/ Fibromax® by Comparison With Fibrosis Score on Liver Biopsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (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
The purpose of this study is to determine if SWE and Fibrotest®/ Fibromax®, alone or associated, are effective methods to assess liver fibrosis in children.
Detailed Description
Liver biopsy will be the gold standard to assess fibrosis using Ishak score and morphometric evaluation of fibrosis. All children included will have a measure of liver stiffness using SWE with 5 measures performed in the area where the biopsy is performed and 5 measures in an other place in the liver. Fibrotest®/ Fibromax® will be performed on blood sample. All exams will be done within 1 month. diagnostic performance of SWE and Fibrotest®/ Fibromax® will be assessed respectively. algorithm using the results of both technics will be tested in order to test diagnostic performance and to obtain better performances.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Fibrosis, Children
Keywords
Diagnostic, Liver fibrosis, Ishak score, Fibrotest, ShearWave elastography, Liver biopsies

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Shearwave electrography
Arm Type
Experimental
Arm Description
Two experimental interventions will be realized in each patient in this population : Shearwave electrography (new diagnostic test of fibrosis) and Fibrotest . Moreover, liver biopsies, the gold standard for the fibrosis diagnosis is also realized in each patient within usual cares.
Intervention Type
Procedure
Intervention Name(s)
Shearwave electrography
Primary Outcome Measure Information:
Title
liver fibrosis evaluated by the ISHAK score and morphometric evaluation
Description
Histology is the gold standard to evaluate liver fibrosis
Time Frame
up to 1 month
Secondary Outcome Measure Information:
Title
liver fibrosis evaluation : stiffness using SHEARWAVE elastography
Time Frame
up 1 month
Title
Liver fibrosis evaluation using Fibrotest (Fibromax)
Time Frame
up 1 month

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age < 18 years; indication to liver biopsy; informed consent of both parents and child if applicable; social insurance Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphanie FRANCHI-ABELA, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
AP-HP, Bicêtre Hospital
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94275
Country
France

12. IPD Sharing Statement

Learn more about this trial

Non Invasive Assessment of Liver Fibrosis in Children: Comparison of ShearWave Elastography, Fibrotest and Liver Biopsy

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