Biliary Atresia Research Network Northeast
- Conditions
- Biliary Atresia
- Registration Number
- NCT06184971
- Lead Sponsor
- Yale University
- 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 factors contribute to improved patient outcomes, to help guide potential improvements in patient care and resource utilization.
- 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 various pediatric hospitals, which leads to certain hospitals only encountering an affected patient once per decade. This rarity and dispersion makes biliary atresia difficult for researchers to study: single-institution studies are limited by low power and only provide narrow snapshots, whereas large NIH-sponsored consortia report highly selected outcomes from only the largest or most dedicated centers and have largely excluded New England. This leaves a significant knowledge gap regarding the management and outcomes at more typical hospitals. The purpose of this study is to collect clinical data from all children with biliary atresia at all hospitals providing pediatric surgical care in the Northeast, even very-low-volume hospitals. This is a retrospective study, only involving chart review. There will be no interaction with subjects, intervention, or collection of specimens for the purposes of this study. The data will only include clinical information that was recorded during the normal course of patient care. The subjects will be de-identified before entry into a HIPAA-compliant data repository. This data repository will allow researchers to pool data, to yield adequate statistical power and assess differences in management and outcomes regarding this very rare condition.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
-
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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Kasai procedure 10 years Need for biliary diversion procedure, including the Kasai portoenterostomy
Death 10 years Patient death
Liver transplant 10 years Need for liver transplant
- Secondary Outcome Measures
Name Time Method Clearance of jaundice 6 months Normalization of serum bilirubin after Kasai procedure
Bilirubin level 10 years Serum bilirubin level
Cholangitis 10 years Clinical diagnosis of cholangitis
Presentation to ED 10 years Patient presentation to the ED for complication related to biliary atresia
Age at follow-up with providers 10 years Frequency and age at most recent follow-up with Pediatric Surgeon and/or Hepatologist
Bleeding 10 years Post-operative bleeding requiring transfusion or return to the OR
Trial Locations
- Locations (14)
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Massachusetts General Hospital for Children
🇺🇸Boston, Massachusetts, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Baystate
🇺🇸Springfield, Massachusetts, United States
UMass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Albany Medical Center/Bernard & Millie Duke's Children's Hospital
🇺🇸Albany, New York, United States
John R. Oishei Children's Hospital
🇺🇸Buffalo, New York, United States
University of Rochester Medical Center/Golisano Children's Hospital
🇺🇸Rochester, New York, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Rhode Island Hospital/Hasbro Children's Hospital
🇺🇸Providence, Rhode Island, United States