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Ultrasound Shear Wave Elastography Evaluation of Suspected and Known Biliary Atresia

Cincinnati Children's Hospital Medical Center logo

Cincinnati Children's Hospital Medical Center

Status

Completed

Conditions

Biliary Atresia

Treatments

Device: Ultrasound Shear Wave Elastography

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT02652533
2015-7320

Details and patient eligibility

About

The investigators plan to investigate the use of US shear wave elastography (SWE), a newly available imaging technology, in children with suspected/known BA.

Full 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.

Enrollment

41 patients

Sex

All

Ages

Under 3 months old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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