Ultrasound Method to Measure Fibrosis of the Liver in Children

Not Applicable

Terminated

• Conditions: Chronic Liver Disease; HCV Coinfection; Non-Alcoholic Fatty Liver Disease; HBV; Drug-Induced Liver Injury
• Interventions: Device: Shear Wave sonoelastography

• Registration Number: NCT02086708
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) provide accurate quantitative measurements that can be used to stage liver fibrosis in pediatric patients with chronic liver disease.

Specific Aims:

To measure liver stiffness with sonoelastography in pediatric and adolescents with suspect diffuse liver disease who will undergo nonfocal liver biopsy as part of their routine clinical care.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2014-03-07
• Study First Submitted QC: 2014-03-11
• Study First Posted: 2014-03-13
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Results First Submitted: 2016-10-05
• Status Verified: 2016-12
• Results First Submitted QC: 2016-12-06
• Last Update Submitted: 2016-12-06
• Results First Posted: 2017-02-01
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Shear Wave Sonoelastography, Fibrosis stage	Shear Wave sonoelastography	Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy.

Primary Outcome Measures

Name	Time	Method
Measure Liver Elasticity Value Using Sonoelastography.	Day one	Assess liver stiffness as measured by sonoelastography with results of liver biopsy as read by a single-pathologist using the METAVIR criteria (F0-F4).

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States