Stage 3 Fontan Operation Liver Ultrasound Study

Completed · Not applicable

Conditions studied: Fontan Operation

In brief

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 elastography (Acoustic Radiation Force Impulse, or ARFI) will measure liver stiffness.

Key facts

Study ID

NCT02269709

Run by

University of Michigan

People needed

21

Starts

2014-11-01

Expected to finish

2016-07-01

Last updated by the study team

2018-01-12

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pediatric patients ages 0-17
• Patients presenting to the University of Michigan for evaluation just before undergoing stage 3 of the Fontan operation

You may not qualify if…

• 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

Where it is running

• University of Michigan Hospital — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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