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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 15 children with increased liver stiffness due to the Fontan operation 15 children with increased liver stiffness caused by Biliary Atresia.

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

Conditions
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Liver Fibroses

Intervention / Treatment
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* Device: Ultrasound with ARFI (acoustic radiation force impulse)
* Device: Ultrasound with backscatter imaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients having Fontan cardiac surgery<br>This group includes pediatric patients, aged 2-5 years, who have had a Fontan operation. This surgery corrects a heart defect found at birth in which the heart has only one ventricle. Patients will have an Ultrasound with ARFI imaging. | Device: Ultrasound with ARFI (acoustic radiation force impulse)<br>* This technology uses sound waves to measure the stiffness of tissue.<br>* Other names: elastography;Device: Ultrasound with backscatter imaging<br>* This ultrasound tool gathers data from the waves returning from imaged tissue.<br>|
| Patients with Liver disease<br>This group includes pediatric patients, aged 2-5 years, who have chronic liver disease caused by biliary atresia. Patients will have an Ultrasound with ARFI imaging. | Device: Ultrasound with ARFI (acoustic radiation force impulse)<br>* This technology uses sound waves to measure the stiffness of tissue.<br>* Other names: elastography;Device: Ultrasound with backscatter imaging<br>* This ultrasound tool gathers data from the waves returning from imaged tissue.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shear wave speed | Shear wave speed is a measure of stiffness of liver tissue expressed in units of m/s | 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver stiffness Fontan