Stage 3 Fontan Operation Liver Ultrasound Study

Fontan Operation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02269709
• Other study ID #: HUM00090329
• Status: Completed
• Phase: N/A
• First received: October 15, 2014
• Last updated: December 13, 2017
• Start date: November 2014
• Est. completion date: July 2016

Study information

• Verified date: November 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

• Pediatric patients ages 0-17

• Patients presenting to the University of Michigan for evaluation just before 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 (parents) who are unwilling to read and sign the informed consent document

Related Conditions & MeSH terms

• Fontan Operation

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shear Wave Speed (Liver Stiffness)	ARFI shear wave speed measurements were done on the right lobe of the liver. Measurement units are m/s (meters per second). A total of 8 measurements were performed on each subject at each time point.The 8 values were performed on each subject and averaged.	0-6 months
Secondary	IVC Pressure	Blood pressure in the IVC, the interior vena cava, was measured from a central line placed for patient care.	Baseline and Follow Up Number 1 (approximately 24 -72 hours later)