Status:
COMPLETED
Increased Liver Stiffness: A Study of Acoustic Radiation Force Impulse (ARFI) Elastography
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Children's Hospital Medical Center, Cincinnati
Conditions:
Liver Fibroses
Eligibility:
All Genders
2-5 years
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 d...
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 live...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 11 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 19 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03382119
Start Date
April 11 2018
End Date
July 19 2019
Last Update
June 2 2020
Active Locations (1)
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1
C.S. Mott Hospital
Ann Arbor, Michigan, United States, 48109