Ultrasound Shear Wave Elastography Evaluation of Suspected and Known Biliary Atresia
- Conditions
- Biliary Atresia
- Registration Number
- NCT02652533
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- Brief Summary
The investigators plan to investigate the use of US shear wave elastography (SWE), a newly available imaging technology, in children with suspected/known BA.
- Detailed Description
The investigators plan a prospective, multi-center study to determine if liver ultrasound shear wave speed measurements acquired at clinical presentation can discriminate biliary atresia (BA) from other causes of liver disease in the setting of neonatal cholestasis. The investigators also plan to determine if liver ultrasound shear wave speed measurements acquired at clinical presentation or longitudinally during the first one-year period after Kasai can predict important long-term outcomes in BA patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- neonatal cholestasis with concern for BA vs. other liver disease direct bilirubin >20% of total or ≥2 mg/dL age <3 months
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Discrimination of biliary atresia from other liver diseases using ultrasound liver shear wave speed (Aim 1) 2 years 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.
- Secondary Outcome Measures
Name Time Method Predicting long term clinical outcomes in biliary atresia patients using ultrasound liver shear wave speed (aim 2) 6 years 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.
Trial Locations
- Locations (4)
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Nationwide Children's
🇺🇸Columbus, Ohio, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Lucile Packard Children's Hospital/Stanford University
🇺🇸Stanford, California, United States