NCT02269709

Stage 3 Fontan Operation Liver Ultrasound Study

Noninvasive Detection of Liver Injury Immediately Following the Fontan Operation: the Role of Ultrasound-Based Elastography

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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

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 introduces immediate congestion of blood in the liver by increasing central venous pressure (CVP). CVP is the blood pressure within the vena cava, a major blood vessel in the body. Many patients later develop progressive liver fibrosis (stiffness) possibly as a result of increased blood pressure. Liver stiffness is increased both by congestion and fibrosis. Liver fibrosis has significant health risks and may complicate the patient's future healthcare. There are no established, noninvasive means of detecting the liver fibrosis until it becomes severe. Acoustic radiation force impulse (ARFI) elastography, an ultrasound technique, can measure the stiffness of the liver safely from outside the body. The investigators hypothesize that liver stiffness will be increased by stage 3 of the Fontan operation due to onset of liver congestion. Using ARFI, 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 follow the trend of liver stiffness at six months by repeating the ARFI imaging.

Conditions

• Fontan Operation

Interventions

Type	Name	Description
DEVICE	ARFI Ultrasound	This research scan uses acoustic radiation force impulse (ARFI) shear wave velocity imaging (SVI). This is a new ultrasound technology in which unique sound waves create the images/pictures of the liver beng examined/scanned. This ultrasound scan will take approximately 10 minutes to complete.

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-06-01
• Completion: 2016-07-01
• First posted: 2014-10-21
• Last updated: 2018-01-12
• Results posted: 2017-08-16

Locations

1 site across 1 country: United States