Ultrasound Shear Wave Elastography Evaluation of Suspected and Known Biliary Atresia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Biliary Atresia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Ultrasound Shear Wave Elastography

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.

Intervention Type DEVICE

Eligibility Criteria

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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).

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No