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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 2
SponsorUniversity Hospital, Geneva

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

recurrent cholangitis, cholangitis >1 year after Kasai

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 1 trial group
Group A: A sample size of 40 patients is targeted, with 20 in each group (suspected and confirmed).

Trial outcomes

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

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: