Increased Liver Stiffness: A Study of Acoustic Radiation Force Impulse (ARFI) Elastography
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.
Study Overview
Status
Conditions
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.
- 15 children with increased liver stiffness due to the Fontan operation
- 15 children with increased liver stiffness caused by Biliary Atresia.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- C.S. Mott Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients having Fontan cardiac surgery
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. |
This technology uses sound waves to measure the stiffness of tissue.
Other Names:
This ultrasound tool gathers data from the waves returning from imaged tissue.
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Patients with Liver disease
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. |
This technology uses sound waves to measure the stiffness of tissue.
Other Names:
This ultrasound tool gathers data from the waves returning from imaged tissue.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Shear wave speed
Time Frame: 15 minutes
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Shear wave speed is a measure of stiffness of liver tissue expressed in units of m/s
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15 minutes
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Frank DiPaola, MD, University of Michigan
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM 130099
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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