Biliary Atresia Research Network Northeast

Biliary Atresia Clinical Trial

— BARNN  

Official title:

Biliary Atresia Research Network Northeast (BARNN)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06184971
• Other study ID #: 2000035645
• Secondary ID: 000
• Status: Recruiting
• Start date: May 6, 2024
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: Yale University
• Contact: Isabelle Curran
• Phone: 203-785-2701
• Email: isabelle.curran[@]yale.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Biliary Atresia

Locations

Country	Name	City	State
United States	Albany Medical Center/Bernard & Millie Duke's Children's Hospital	Albany	New York
United States	Eastern Maine Medical Center	Bangor	Maine
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital for Children	Boston	Massachusetts
United States	John R. Oishei Children's Hospital	Buffalo	New York
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Yale University	New Haven	Connecticut
United States	Maine Medical Center	Portland	Maine
United States	Rhode Island Hospital/Hasbro Children's Hospital	Providence	Rhode Island
United States	University of Rochester Medical Center/Golisano Children's Hospital	Rochester	New York
United States	Baystate	Springfield	Massachusetts
United States	SUNY Upstate Medical University	Syracuse	New York
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	Patient death	10 years
Primary	Kasai procedure	Need for biliary diversion procedure, including the Kasai portoenterostomy	10 years
Primary	Liver transplant	Need for liver transplant	10 years
Secondary	Clearance of jaundice	Normalization of serum bilirubin after Kasai procedure	6 months
Secondary	Bilirubin level	Serum bilirubin level	10 years
Secondary	Cholangitis	Clinical diagnosis of cholangitis	10 years
Secondary	Bleeding	Post-operative bleeding requiring transfusion or return to the OR	10 years
Secondary	Presentation to ED	Patient presentation to the ED for complication related to biliary atresia	10 years
Secondary	Age at follow-up with providers	Frequency and age at most recent follow-up with Pediatric Surgeon and/or Hepatologist	10 years