Biliary Atresia, Kasai Portoenterostomy StatusTRACK-BANCT07129655
Cholangitis Definition and Treatment After Kasai Hepatoportoenterostomy for Biliary Atresia: TRACK-BA Study (TRacking Cholangitis Post Kasai in Biliary Atresia)
An observational study of Biliary Atresia, Kasai Portoenterostomy Status and Cholangitis, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Biliary Atresia, Kasai Portoenterostomy Status, Cholangitis
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2025to 30 Sep 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- patients with a suspected diagnosis cholangitis within 1 year after Kasai hepatoportoenterostomy
Who cannot join
- recurrent cholangitis, cholangitis >1 year after Kasai
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Hôpitaux Universitaires de Genève
Geneva, 1205
Rachel Goldstein, +41 22 372 46 62, rachel.goldstein@hug.ch
About this study
Official title: Cholangitis Definition and Treatment After Kasai Hepatoportoenterostomy for Biliary Atresia: a Feasibility Study
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.
Read more
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.
Read the 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.
- Keywords
- biliary atresia, Kasai hepatoportoenterostomy, acute cholangitis
- Medical subject headings
- Biliary Atresia, Cholangitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the applicability of the definitions for suspected and confirmed cholangitis.
Measured: 12 months
Secondary outcomes (1)
Duration of treatment for suspected and confirmed cholangitis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Biliary Atresia, Kasai Portoenterostomy StatusStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Calinescu Ana M., University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129655
- Sponsor's protocol ID
- 2021-01251
- Acronym
- TRACK-BA
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Individual Participant Data (IPD) to be shared will include anonymised clinical, demographic, and outcome data relevant to the study objectives. Demographic data: Age, sex, weight, gestational age at birth. Clinical data: Diagnosis date, baseline lab values, imaging results. Treatment data: Assigned group, medications used, dates of intervention. Follow-up data: Lab results over time, response to treatment.
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.
PubMed 39149194Calinescu 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.
PubMed 35159946
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholangitis Definition and Treatment After Kasai Hepatoportoenterostomy for Biliary Atresia: a Feasibility Study
- ClinicalTrials.gov ID
- NCT07129655
- Acronym / sponsor ID
- TRACK-BA / 2021-01251
- Keywords
- biliary atresia, Kasai hepatoportoenterostomy, acute cholangitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- patients with a suspected diagnosis cholangitis within 1 year after Kasai hepatoportoenterostomy
Key exclusion criteria (1 listed)
- recurrent cholangitis, cholangitis >1 year after Kasai
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the applicability of the definitions for suspected and confirmed cholangitis.
Time frame: 12 months
1 secondary outcome
Duration of treatment for suspected and confirmed cholangitis
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Background: PubMed 39149194Madadi-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.
- Background: PubMed 35159946Calinescu 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.
- Individual participant dataSharing planned: Yes. The Individual Participant Data (IPD) to be shared will include anonymised clinical, demographic, and outcome data relevant to the study objectives. Demographic data: Age, sex, weight, gestational age at birth. Clinical data: Diagnosis date, baseline lab values, imaging results. Treatment data: Assigned group, medications used, dates of intervention. Follow-up data: Lab results over time, response to treatment.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Atresia, Kasai Portoenterostomy Status and Cholangitis, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PD Dr Ana M. Calinescu, MD (+41 79 55 32 627, ana-maria.calinescu@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the applicability of the definitions for suspected and confirmed cholangitis. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07129655, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.