Ultrasound Shear Wave Elastography Evaluation of Suspected and Known Biliary Atresia
1 other identifier
observational
41
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2016
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2015
CompletedFirst Posted
Study publicly available on registry
January 12, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedSeptember 23, 2019
March 1, 2018
2.3 years
December 18, 2015
September 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
2 years
Secondary Outcomes (1)
Predicting long term clinical outcomes in biliary atresia patients using ultrasound liver shear wave speed (aim 2)
6 years
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.
Eligibility Criteria
neonatal cholestasis with concern for BA vs. other liver disease direct bilirubin \>20% of total or ≥2 mg/dL age \<3 months
You may qualify if:
- neonatal cholestasis with concern for BA vs. other liver disease direct bilirubin \>20% of total or ≥2 mg/dL age \<3 months
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Lucile Packard Children's Hospital/Stanford University
Stanford, California, 94305, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Nationwide Children's
Columbus, Ohio, 43205, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Dillman, MD
Children's Hospital Medical Center, Cincinnati
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2015
First Posted
January 12, 2016
Study Start
September 1, 2016
Primary Completion
January 1, 2019
Study Completion
July 1, 2019
Last Updated
September 23, 2019
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share