An observational study in Biliary Atresia, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 4 sites in United States. Open to participants aged Up to 3 Months. Per ClinicalTrials.gov, last updated 2019-09-23.
Sponsored by Children's Hospital Medical Center, Cincinnati · 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.
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.
75 studies on the registry are indexed under Biliary Atresia; 25 are open to participants now.
This study's enrollment of 41 is below the median of 126 across 31 observational studies indexed under Biliary Atresia.
Browse Biliary Atresia studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 132 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
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neonatal cholestasis with concern for BA vs. other liver disease direct bilirubin >20% of total or ≥2 mg/dL age \<3 months
Exclusion Criteria:
The investigators have recently published a very small study in neonates/infants with suspected BA showing that US liver shear wave speed (i.e. - liver stiffness) can differentiate BA from other causes of cholestasis, potentially with a very high degree of accuracy. Additional research is needed to confirm these very preliminary results and determine if liver shear wave speed measurements either before or after (including longitudinally) Kasai can predict key outcomes.
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.
Time frame: 2 years
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.
Time frame: 6 years
Plan to share: No
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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Children's Hospital Medical Center, Cincinnati