Ultrasound Method to Measure Fibrosis of the Liver in Children

N/ATerminatedNCT02086708

Massachusetts General Hospital24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Chronic Liver Disease Non-Alcoholic Fatty Liver Disease HCV Coinfection HBV Drug-Induced Liver Injury

Interventions

Shear Wave sonoelastographyDEVICE

Shear Wave Sonoelastography as a ultrasound technique to measure liver fibrosis is performed on patients scheduled for non-focal liver biopsy. Results are compared with pathological score of fibrosis from liver biopsy.

Eligibility

Sex: ALLMin age: 1 YearMax age: 21 Years

Medical Language ↔ Plain English

Inclusion criteria: * Patients scheduled for random liver biopsy for routine staging of liver fibrosis * Pediatric patients patients (ages 1-21) * Girls or boys * Suspected liver disease * Consent to participate in the study Exclusion criteria: * Pregnancy * Acute illness/cognitive impairment resulting in inability to cooperate with ultrasound * Patients that do not consent to ultrasound guided liver biopsy. * Contraindications to liver biopsy (e.g. low platelets defined as a platelet count of less than 50,000, and hemophilia/coagulopathy as an INR higher than 1.5.)

Outcomes

Primary Outcomes

Measure Liver Elasticity Value Using Sonoelastography.

Assess liver stiffness as measured by sonoelastography with results of liver biopsy as read by a single-pathologist using the METAVIR criteria (F0-F4).

Time frame: Day one