Cholangitis Definition and Treatment After Kasai Hepatoportoenterostomy for Biliary Atresia: TRACK-BA Study (TRacking Cholangitis Post Kasai in Biliary Atresia)

NCT07129655 | Not Yet Recruiting

• 1 other identifier: 2021-01251
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Biliary atresia is a rare liver disease affecting newborns. In those babies bile ducts are blocked, and bile cannot flow from the liver to the intestines. Biliary atresia patients require a special surgery called "Kasai operation" to restore the bile flow. A common and serious problem after surgery is an infection of the bile ducts, called cholangitis, which can damage the liver and lead an earlier need for liver transplantation. In 2022, a group of international experts led by the Swiss Pediatric Liver Center from the HUG created new guidelines to help identify and treat cholangitis more consistently. This study will test how well these new definitions work in real life of hospitals. Over one year, physicians will collect data on children in whom they suspect cholangitis in the first year after their Kasai. The goal is to see whether these new definitions are applicable in the clinical setting. The study will involve around 40 patients and will use secure methods to store data. The findings will help improve how cholangitis is diagnosed and treated, making care more effective and consistent for children with biliary atresia.

Conditions

Biliary Atresia, Kasai Portoenterostomy Status; Cholangitis

Keywords

biliary atresia; Kasai hepatoportoenterostomy; acute cholangitis

Outcome Measures

Primary Outcomes (1)

• To assess the applicability of the definitions for suspected and confirmed cholangitis.

  12 months

Secondary Outcomes (1)

• Duration of treatment for suspected and confirmed cholangitis

  1 year

Study Arms (1)

A sample size of 40 patients is targeted, with 20 in each group (suspected and confirmed).

Patients with a suspected diagnosis cholangitis within 1 year after Kasai hepatoportoenterostomy: This includes patients for whom 1. cholangitis will not be finally confirmed , 2. cholangitis is finally confirmed.

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Definition and treatment of cholangitis after Kasai hepatoportoenterostomy were established after an international consensus of a panel of experts led by the Swiss Pediatric Liver Center within the Geneva University Hospitals.

You may qualify if:

• patients with a suspected diagnosis cholangitis within 1 year after Kasai hepatoportoenterostomy

You may not qualify if:

• recurrent cholangitis, cholangitis \>1 year after Kasai

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Hôpitaux Universitaires de Genève

Geneva, 1205, Switzerland

Location

Related Publications (2)

• Madadi-Sanjani O, Calinescu AM, Rock N, McLin VA, Uecker M, Kuebler JF, Petersen C, Wildhaber BE. Retrospective analysis of the standardized BARD criteria for acute cholangitis in biliary atresia patients. JPGN Rep. 2024 Apr 12;5(3):309-316. doi: 10.1002/jpr3.12071. eCollection 2024 Aug.

  PMID: 39149194 BACKGROUND

• Calinescu AM, Madadi-Sanjani O, Mack C, Schreiber RA, Superina R, Kelly D, Petersen C, Wildhaber BE. Cholangitis Definition and Treatment after Kasai Hepatoportoenterostomy for Biliary Atresia: A Delphi Process and International Expert Panel. J Clin Med. 2022 Jan 19;11(3):494. doi: 10.3390/jcm11030494.

  PMID: 35159946 BACKGROUND

MeSH Terms

Conditions

Biliary Atresia; Cholangitis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

PD Dr Ana M. Calinescu, MD

CONTACT

+41 79 55 32 627; ana-maria.calinescu@hug.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr Ana M. Calinescu

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 19, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Access Criteria: There will be three physicians responsible per site, as well as one dedicated person in charge of data entry into the database.

Locations

CH (1)