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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank W DiPaola, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Hospital | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ARFI Ultrasound | Subjects were pediatric patients who had undergone a repair of a heart defect, called a Fontan operation. Patients underwent an ultrasound before and after the Fontan operation. The ultrasound scan used acoustic radiation force impulse (ARFI) shear wave velocity imaging (SVI). This is a non-invasive scan that uses sound waves to create images of the liver and measure its stiffness. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Time of Enrollment |
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| Follow-up #1 (24-72 Hours Post-surgery) |
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| Prior to Hospital Discharge |
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| Six Month Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | ARFI Ultrasound | Subjects were pediatric patients who had undergone a Fontan operation. Subjects underwent an ultrasound before and after the Fontan operation. The ultrasound scan used acoustic radiation force impulse (ARFI) shear wave velocity imaging (SVI). This is a non-invasive scan that uses sound waves to create images of the liver and measure the stiffness of the tissue. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | As shown in the participant flow, data was not captured for follow up time points 1 and 2 for 1 participant. At time point 3 data is only available for 5 participants. | Posted | Mean | Standard Deviation | meters per second | 0-6 months |
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Patients were followed for adverse events through their last hospital visit which was up to 6 months at the latest.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ARFI Ultrasound | Subjects underwent an ultrasound scan before and after the Fontan operation. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frank W. DiPaola, MD | University of Michigan | 734-763-9650 | dipaolaf@med.umich.edu |
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| Months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Age by Sex | The age of each gender group (males and females) is compared. | Mean | Full Range | Months |
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| Participants |
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| Secondary | IVC Pressure | Blood pressure in the IVC, the interior vena cava, was measured from a central line placed for patient care. | Subjects who had undergone the Fontan operation and who had a central line placed. Blood pressure values were obtained from chart review. | Posted | Mean | Standard Error | mmHg | Baseline and Follow Up Number 1 (approximately 24 -72 hours later) |
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| 18 |
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| 18 |
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| 18 |
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