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| Name | Class |
|---|---|
| Children's Hospital Medical Center, Cincinnati | OTHER |
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The goal of this study is to determine if ultrasound tools can be used to detect liver stiffness. Acoustic radiation force impulse (ARFI) elastography and backscatter will be used to see if they can detect liver stiffness in different populations of patients with liver disease.
The study is measuring liver stiffness in pediatric patients aged 2-5 years. Patients either have had a Fontan cardiac surgery or have liver disease.
Ultrasound scanning takes images of the liver and has much lower risks for patients. ARFI elastography and other tools can be used to measure liver stiffness.
If patients have liver congestion, reversing it could prevent liver fibrosis, which cannot be treated. Liver fibrosis has serious health risks and is associated with a higher chance of developing liver cancer later in life.
Subjects from two patient populations will be enrolled in order to test ultrasound technologies. A total of 30 subjects between 2-5 years of age will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients having Fontan cardiac surgery | This group includes pediatric patients, aged 2-5 years, who have had a Fontan operation. This surgery corrects a heart defect found at birth in which the heart has only one ventricle. Patients will have an Ultrasound with ARFI imaging. |
| |
| Patients with Liver disease | This group includes pediatric patients, aged 2-5 years, who have chronic liver disease caused by biliary atresia. Patients will have an Ultrasound with ARFI imaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound with ARFI (acoustic radiation force impulse) | Device | This technology uses sound waves to measure the stiffness of tissue. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Shear wave speed | Shear wave speed is a measure of stiffness of liver tissue expressed in units of m/s | 15 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will either be scheduled for a Stage 3 Fontan cardiac operation or have chronic liver disease caused by biliary atresia.
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| Name | Affiliation | Role |
|---|---|---|
| Frank DiPaola, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C.S. Mott Hospital | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D054459 | Elasticity Imaging Techniques |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| Ultrasound with backscatter imaging | Device | This ultrasound tool gathers data from the waves returning from imaged tissue. |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |