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NCT Number: NCT07129655

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

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.

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Key information

Conditions

Biliary Atresia, Kasai Portoenterostomy Status Bile Duct Diseases Biliary Atresia Biliary Tract Diseases Cholangitis Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • recurrent cholangitis, cholangitis >1 year after Kasai

Treatment and study plan

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  1. Duration of treatment for suspected and confirmed cholangitis

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

PD Dr Ana M. Calinescu, MD

CONTACT

[email protected]

+41 79 55 32 627

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

Cholangitis Definition and Treatment After Kasai Hepatoportoenterostomy for Biliary Atresia: a Feasibility Study

Acronym: TRACK-BA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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