Increased Liver Stiffness: A Study of Acoustic Radiation Force Impulse (ARFI) Elastography

University of Michigan25 enrolled

Overview

The goal of this study is to determine if ultrasound tools can be used to detect liver stiffness. Acoustic radiation force impulse (ARFI) elastography and backscatter will be used to see if they can detect liver stiffness in different populations of patients with liver disease. The study is measuring liver stiffness in pediatric patients aged 2-5 years. Patients either have had a Fontan cardiac surgery or have liver disease. Ultrasound scanning takes images of the liver and has much lower risks for patients. ARFI elastography and other tools can be used to measure liver stiffness.

If patients have liver congestion, reversing it could prevent liver fibrosis, which cannot be treated. Liver fibrosis has serious health risks and is associated with a higher chance of developing liver cancer later in life. Subjects from two patient populations will be enrolled in order to test ultrasound technologies. A total of 30 subjects between 2-5 years of age will be enrolled. 1. 15 children with increased liver stiffness due to the Fontan operation 2. 15 children with increased liver stiffness caused by Biliary Atresia.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Liver Fibroses

Interventions

Ultrasound with ARFI (acoustic radiation force impulse)DEVICE

This technology uses sound waves to measure the stiffness of tissue.

Ultrasound with backscatter imagingDEVICE

This ultrasound tool gathers data from the waves returning from imaged tissue.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 5 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged 2-5 years * Children who are scheduled to have a Stage 3 Fontan cardiac operation (arm 1) AND Children who have chronic liver disease caused by biliary atresia (arm 2) * Patient must be receiving care at the University of Michigan CS Mott Children's Hospital * Parent/guardian must be willing to sign the study consent form Exclusion Criteria: * For arm 1 subjects: pre-existing evidence of chronic liver disease (as defined by chronic elevation (over 4 weeks) of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or conjugated bilirubin to greater than two times the upper limit of normal * For arm 1 subjects: evidence of overt liver nodularity by conventional US imaging or evidence of portal vein or hepatic vein thrombosis (clots) by US Doppler exam

Locations (1)

C.S. Mott Hospital

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Shear wave speed

Shear wave speed is a measure of stiffness of liver tissue expressed in units of m/s

Time frame: 15 minutes

Data from ClinicalTrials.gov

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