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

NCT ID: NCT07129655

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-09-30

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.

Detailed Description

This prospective, observational study will be conducted across hospitals managing pediatric biliary atresia patients. Data on suspected cholangitis cases in the first year post Kasai hepatoportoenterostomy will be collected by mini-teams of three healthcare providers over twelve months. Data will be anonymized, and the study will adhere to international ethical standards.

Inclusion Criteria:

• Patients with biliary atresia suspected of cholangitis within one year post Kasai hepatoportoenterostomy.
• Data from specialties including pediatric surgery, pediatric hepatology, and pediatric emergency care.

Exclusion Criteria:

• Recurrent cholangitis or cholangitis after one-year post Kasai hepatoportoenterostomy.

Definitions: Cholangitis will be defined by clinical confirmation, improvement with antimicrobial therapy, and lab value changes.

Primary Aim: To assess the application of consensus definitions for suspected and confirmed cholangitis.

Secondary Aim: To evaluate the proposed duration of treatment for cholangitis and compare it to clinical practice.

Data Collection: Data will be stored using the secure REDCap platform, managed by the University of Geneva. Local investigators are responsible for ethical approvals.

Expected Results: This study will assess the practicality of applying expert panel definitions for cholangitis after Kasai hepatoportoenterostomy and gather feedback from clinicians. A sample size of 40 patients is targeted, with 20 in each group (suspected and confirmed). Findings will help refine diagnostic criteria.

Conditions

Biliary Atresia, Kasai Portoenterostomy Status; Cholangitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• recurrent cholangitis, cholangitis >1 year after Kasai

• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Calinescu Ana M.

PD Dr Ana M. Calinescu

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hôpitaux Universitaires de Genève

Geneva, , Switzerland

Countries

Switzerland

Central Contacts

PD Dr Ana M. Calinescu, MD

Role: CONTACT

ana-maria.calinescu@hug.ch

+41 79 55 32 627

Facility Contacts

Rachel Goldstein

Role: primary

rachel.goldstein@hug.ch

+41 22 372 46 62

References

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.

Reference Type: BACKGROUND

PMID: 39149194 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35159946 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: Study protocol and statistical analysis plan

View Document

Document Type: Study Protocol: Case Report Form

View Document

Other Identifiers

2021-01251

Identifier Type: -

Identifier Source: org_study_id