Biliary Atresia Research Network Northeast (NCT06184971) | Clinical Trial Compass
CompletedNot Applicable
Biliary Atresia Research Network Northeast
United States320 participantsStarted 2024-05-06
Plain-language 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 factors contribute to improved patient outcomes, to help guide potential improvements in patient care and resource utilization.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.