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Ann Arbor, Michigan 48109


Purpose:

The purpose of this study is to distinguish between the impacts of congestion and fibrosis on liver stiffness in post-Fontan operation pediatric patients using a new form of ultrasound (Acoustic Radiation Force Impulse (ARFI) elastography)


Study summary:

The Fontan repair for single ventricle congenital heart lesions consists of three stages, and long-term survival is expected. Stage 3 introduces immediate congestion of blood within the liver by increasing central venous pressure (CVP) and many patients later develop progressive liver fibrosis. There are no established, noninvasive means of detecting the liver fibrosis until it has become severe. Ultrasound acoustic radiation force impulse (ARFI) elastography can noninvasively measure the stiffness of the liver, which is increased both by congestion and fibrosis. The investigators hypothesize that liver stiffness will be increased by stage 3 of the operation due to onset of liver congestions. Using ARFI elastography, the investigators will measure liver stiffness before and immediately after stage 3 of the Fontan operation, when congestion of blood is likely the only contributor to any change in liver stiffness. The investigators will also characterize the relationship between liver stiffness and CVP. The investigators will then trend liver stiffness over a one-year time point by repeating the ARFI imaging.


Criteria:

Inclusion Criteria: - Pediatric patients ages 0-17 - Patients presenting to the University of Michigan for evaluation just prior to undergoing stage 3 of the Fontan operation Exclusion Criteria: - 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 who are unwilling to read and sign the informed consent document


NCT ID:

NCT02269709


Primary Contact:

Principal Investigator
Frank W DiPaola, MD
University of Michigan


Backup Contact:

N/A


Location Contact:

Ann Arbor, Michigan 48109
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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