Biliary Atresia Clinical Trial
Official title:
Ultrasound Shear Wave Elastography Evaluation of Suspected and Known Biliary Atresia
NCT number | NCT02652533 |
Other study ID # | 2015-7320 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2016 |
Est. completion date | July 2019 |
Verified date | March 2018 |
Source | Children's Hospital Medical Center, Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The investigators plan to investigate the use of US shear wave elastography (SWE), a newly available imaging technology, in children with suspected/known BA.
Status | Completed |
Enrollment | 41 |
Est. completion date | July 2019 |
Est. primary completion date | January 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 3 Months |
Eligibility |
Inclusion Criteria: - neonatal cholestasis with concern for BA vs. other liver disease direct bilirubin >20% of total or =2 mg/dL age <3 months Exclusion Criteria: - inability to obtain parent/guardian consent. - inability to return for follow up visits as required by the study (these patients will be included in aim 1, but will be unable to participate in aim 2). - no other exclusion criteria. |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Nationwide Children's | Columbus | Ohio |
United States | Lucile Packard Children's Hospital/Stanford University | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati | Siemens Medical Solutions |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Discrimination of biliary atresia from other liver diseases using ultrasound liver shear wave speed (Aim 1) | The primary outcome measure will be ultrasound shear wave speed of the liver. The investigators will compare the mean liver shear wave speed measurements in children with biliary atresia to other liver diseases. Sensitivity and specificity of ultrasound for diagnosing biliary atresia will be determined using multiple shear wave speed cut-off values. | 2 years | |
Secondary | Predicting long term clinical outcomes in biliary atresia patients using ultrasound liver shear wave speed (aim 2) | Change in shear speed liver over time will be compared between children with biliary atresia versus other liver diseases in order to determine if differences predict important clinical outcomes. | 6 years |
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