Biliary Atresia Research Network Northeast

NCT06184971 | Active Not Recruiting

• 2 other identifiers: 2000035645000
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 14

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.

Conditions

Biliary Atresia

Outcome Measures

Primary Outcomes (3)

• Death

  Patient death

  10 years

• Kasai procedure

  Need for biliary diversion procedure, including the Kasai portoenterostomy

  10 years

• Liver transplant

  Need for liver transplant

  10 years

Secondary Outcomes (6)

• Clearance of jaundice

  6 months

• Bilirubin level

  10 years

• Cholangitis

  10 years

• Bleeding

  10 years

• Presentation to ED

  10 years

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children 12 years and younger (at the time of the qualifying encounter for care) who were diagnosed with biliary atresia, underwent surgical intervention for biliary atresia, and/or had an encounter for care related to biliary atresia at a participating institution during the study period. Patients who did not undergo surgery will be included (e.g. patients who died before surgery).

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead

Study Sites (14)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Massachusetts General Hospital for Children

Boston, Massachusetts, 02114, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Baystate

Springfield, Massachusetts, 01199, United States

Location

UMass Memorial Medical Center

Worcester, Massachusetts, 01605, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Albany Medical Center/Bernard & Millie Duke's Children's Hospital

Albany, New York, 12208, United States

Location

John R. Oishei Children's Hospital

Buffalo, New York, 14203, United States

Location

University of Rochester Medical Center/Golisano Children's Hospital

Rochester, New York, 14642, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Rhode Island Hospital/Hasbro Children's Hospital

Providence, Rhode Island, 02905, United States

Location

MeSH Terms

Conditions

Biliary Atresia

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Robert Cowles, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 29, 2023
• Study Start: May 6, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

US (14)