An observational study in Biliary Atresia, Kasai Portoenterostomy Status and Cholangitis, sponsored by University Hospital, Geneva. Not yet recruiting at 1 site in Switzerland. Open to participants aged Up to 2 Years. Per ClinicalTrials.gov, last updated 2025-08-19.
Sponsored by University Hospital, Geneva · Observational
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.
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:
Exclusion Criteria:
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.
77 studies on the registry are indexed under Biliary Atresia; 25 are open to participants now.
This study's planned enrollment of 40 is below the median of 123 across 32 observational studies indexed under Biliary Atresia.
Browse Biliary Atresia studies →University Hospital, Geneva is the lead sponsor of 379 studies on the registry; 70 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
To assess the applicability of the definitions for suspected and confirmed cholangitis.
Time frame: 12 months
Duration of treatment for suspected and confirmed cholangitis
Time frame: 1 year
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, 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.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.