Status:
COMPLETED
Stage 3 Fontan Operation Liver Ultrasound Study
Lead Sponsor:
University of Michigan
Conditions:
Fontan Operation
Eligibility:
All Genders
Up to 17 years
Phase:
NA
Brief Summary
The purpose of this study is to compare the liver stiffness, which can be caused by congestion and fibrosis in pediatric patients before and after a Fontan heart operation. A new form of ultrasound e...
Detailed Description
The Fontan repair for single ventricle congenital heart lesions consists of three stages. This surgery has enable pediatric patients who have the repair to live into adulthood. Stage 3 of the surgery...
Eligibility Criteria
Inclusion
- Pediatric patients ages 0-17
- Patients presenting to the University of Michigan for evaluation just before undergoing stage 3 of the Fontan operation
Exclusion
- Patients over the age of 17
- Patients who have chronic liver disease (elevation of ALT, AST, or Bilirubin greater than two times the upper limits of normal \>4 weeks)
- Patients who have evidence of liver enlargement or nodularity on prior ultrasound imaging
- Patients who have a history of portal vein or hepatic vein thrombosis
- Patients (parents) who are unwilling to read and sign the informed consent document
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT02269709
Start Date
November 1 2014
End Date
July 1 2016
Last Update
January 12 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109