Biliary Atresia
Conditions
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.
Interventions
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.
Sponsors
Siemens Medical Solutions
Children's Hospital Medical Center, Cincinnati
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed