Liver Fibroses
Conditions
Keywords
liver stiffness Fontan
Brief summary
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
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.
Interventions
DEVICEUltrasound with ARFI (acoustic radiation force impulse)
This technology uses sound waves to measure the stiffness of tissue.
DEVICEUltrasound with backscatter imaging
This ultrasound tool gathers data from the waves returning from imaged tissue.
Sponsors
Children's Hospital Medical Center, Cincinnati
University of Michigan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shear wave speed | 15 minutes | Shear wave speed is a measure of stiffness of liver tissue expressed in units of m/s |
Countries
United States
Outcome results
None listed