Status:
RECRUITING
Biliary Atresia Research Network Northeast
Lead Sponsor:
Yale University
Conditions:
Biliary Atresia
Eligibility:
All Genders
Up to 12 years
Brief Summary
This is a multi-center retrospective chart review to compile a data repository of the management and outcomes of children with biliary atresia. Overall, investigators aim to evaluate which specific fa...
Detailed Description
Biliary atresia is quite rare, with only 0.73 cases per 10,000 births in the US. Due to this rarity and the geographical spread of the US, the small number of cases end up being dispersed amongst the ...
Eligibility Criteria
Inclusion
- Children with a healthcare encounter related to biliary atresia at a participating institution during the study period (January 1st, 2012 through December 31st, 2021)
- Age 12 years and younger at the time of the qualifying encounter during the study period (encompassing patients born between January 2nd, 1999 through December 31st, 2021)
- Diagnosis of biliary atresia, based on one of the following ICD-10 codes:
- Q44.2 Atresia of bile ducts
- Q44.3 Congenital stenosis and stricture of bile ducts
- Q44.4 Disorders of the biliary tract with major complication or comorbidity
- Q44.5 Other congenital malformations of the bile ducts
- Q44.6 Disorders of the biliary tract without major complication or comorbidity
Exclusion
- Patients aged 13 years old or older during the study period (i.e. those born before January 2nd, 1999)
- Patients born and/or diagnosed with biliary atresia after the end of the study period (i.e. those born after December 31st, 2021)
- No diagnosis of biliary atresia
- History of biliary atresia without any episodes of care related to biliary atresia during the study period (e.g. a teenager with history of BA who underwent Kasai procedure as an infant and has no current issues related to their BA and is receiving care for an unrelated reason)
Key Trial Info
Start Date :
May 6 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06184971
Start Date
May 6 2024
End Date
December 1 2025
Last Update
July 1 2025
Active Locations (14)
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1
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
2
Yale University
New Haven, Connecticut, United States, 06510
3
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
4
Maine Medical Center
Portland, Maine, United States, 04102