Clinical Trial: Ultrasound Shear Wave Elastography Evaluation of Suspected and Known Biliary Atresia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Ultrasound Shear Wave Elastography Evaluation of Suspected and Known Biliary Atresia

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 Summary: 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.
Sponsor: Children's Hospital Medical Center, Cincinnati

Current Primary Outcome: Discrimination of biliary atresia from other liver diseases using ultrasound liver shear wave speed (Aim 1) [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Predicting long term clinical outcomes in biliary atresia patients using ultrasound liver shear wave speed (aim 2) [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Children's Hospital Medical Center, Cincinnati

Dates:
Date Received: December 18, 2015
Date Started: September 2016
Date Completion: March 2024
Last Updated: January 30, 2017
Last Verified: January 2017