N/A
N=21
Stage 3 Fontan Operation Liver Ultrasound Study
Fontan Operation
Bottom Line
View on ClinicalTrials.gov: NCT02269709 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Shear Wave Speed (Liver Stiffness) — 1.18; 2.28; 2.22; 2.08 meters per second — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ARFI Ultrasound (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Shear Wave Speed (Liver Stiffness) |
1.18; 2.28; 2.22; 2.08 | <0.0001 sig |
| SECONDARY IVC Pressure |
7.2; 16.44 | <0.05 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02269709). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.