Can Ultrasound Tests Before and After Fontan Surgery Help Predict Liver Disease and Other Health Problems?

Phase: Active, no longer recruiting

First Posted: October

Condition(s): Fontan Associated Liver Disease

NCT Number: NCT03914196

What Is the Purpose of This Study?

The purpose of this study is to examine whether ultrasound shear wave elastography can measure liver congestion in patients who have had the Fontan operation. The study will also explore whether liver congestion can help predict Fontan-associated liver disease and other complications.

 

Who Can Take Part in This Study?

People who may be eligible for this study are:

  • Single ventricle physiology congenital heart disease undergoing Fontan operation;
  • Ages 0 to 5 years of age at the time of stage 3 Fontan operation;
  • Able to return for follow-up imaging.

What Will Happen During This Study?

  • All patients that are undergoing a Fontan Palliation during cardiothoracic surgery.
  • Diagnostic test: Liver stiffness ultrasound
    • Research imaging will include liver assessments of stiffness (ultrasound shear wave elastography), tissue attenuation (if available), and blood flow (gray-scale and Doppler imaging).
    • Other names: Shear wave elastography (also called ARFI)

Principal Investigator

Dieudonne S. Nonga Makon
MD

Gastroenterology, Hepatology & Nutrition

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