Cholangitis Definition and Treatment After Kasai Hepatoportoenterostomy for Biliary Atresia: TRACK-BA Study (TRacking Cholangitis Post Kasai in Biliary Atresia)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Biliary Atresia, Kasai Portoenterostomy Status, Cholangitis. Basic parameters: up to 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cholangitis Definition and Treatment After Kasai Hepatoportoenterostomy for Biliary Atresia: a Feasibility Study
Overview
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.
Primary outcome measures
- To assess the applicability of the definitions for suspected and confirmed cholangitis. [Time frame: 12 months]
Secondary outcome measures (1)
- Duration of treatment for suspected and confirmed cholangitis [Time frame: 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- Hôpitaux Universitaires de Genève — Geneva
Publications
- 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
- 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
Identifiers
NCT: NCT07129655 · 2021-01251