Stage 3 Fontan Operation Liver Ultrasound Study

NCT02269709 | Completed Results DMC

• 1 other identifier: HUM00090329
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fontan Operation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• IVC Pressure

  Baseline and Follow Up Number 1 (approximately 24 -72 hours later)

Study Arms (1)

ARFI Ultrasound

EXPERIMENTAL

This study uses ultrasound scanning with acoustic radiation force impulse shear wave velocity imaging to measure pediatric liver fibrosis. Patients will be children who have had the Fontan operation. This is a non-invasive scan that uses sound waves to create images.

Device: ARFI Ultrasound

Interventions

ARFI Ultrasound DEVICE

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.

ARFI Ultrasound

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

Limitations and Caveats

The study is limited by the small sample size and the limited capture of follow-up Ultrasound Shear Wave Elastography data at the 6 month time point. Most patients who underwent Fontan operations received follow-up care closer to home.

Results Point of Contact

• Title: Frank W. DiPaola, MD
• Organization: University of Michigan

dipaolaf@med.umich.edu

734-763-9650

Study Officials

• Frank W DiPaola, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 21, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: January 12, 2018
• Results First Posted: August 16, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)