Cholangitis Definition and Treatment After Kasai Hepatoportoenterostomy for Biliary Atresia: a Feasibility Study
Conditions: Biliary Atresia, Kasai Portoenterostomy Status, Cholangitis
Sponsor: University Hospital, Geneva

Cholangitis definition and treatment protocol version 4.0 (16 Avril 2025) 
 
Cholangitis definition and treatment after Kasai hepatoportoenterostomy for biliary 
atresia: TRACK-BA study (TRacking Cholangitis post Kasai in Biliary Atresia) 
 
 
Contact information: 
Email: 
 
Ana-maria.calinescu@hug.ch 
 
 
Summary 
- 
Prospective, observational international feasibility study (NCT number pending, 
Protocol ID 2021-01251) 
- 
Any hospital treating biliary atresia patients after Kasai hepatoportoenterostomy can 
participate. 
- 
Inclusion: All patients presenting with suspected and confirmed cholangitis during the 
first year after Kasai hepatoportoenterostomy 
- 
Twelve months data collection period. No changes should be made to normal patient 
care/ follow-up pathways. 
- 
Primary outcome: Applicability of the cholangitis definition and management 
guidelines in a broad clinical setting. 
- 
All collaborators will be included as PubMed-citable co-authors on resulting 
publications. 
 
Background 
● Acute cholangitis 
is 
one 
of the 
most 
serious 
complications 
after Kasai 
hepatoportoenterostomy for biliary atresia due to its negative impact on prognosis, repeated 
bouts of cholangitis decreasing patient survival.  
● In the absence of standard criteria for diagnosis of acute cholangitis after Kasai 
hepatoportoenterostomy, practical treatment guidelines have never been established; over 
and under treatment might be avoided, reporting might be standardized.  
● Definition and treatment of cholangitis after Kasai hepatoportoenterostomy were 
established through a Delphi method, an extensive literature review, iterative rounds of 
surveys and expert panel discussions*. 
● This feasibility study will collect data about biliary atresia patients clinically diagnosed to 
have a cholangitis during the 1st year after Kasai, so that data for suspected and confirmed 
cholangitis can be assessed. 
 
* Cholangitis definition and treatment after Kasai hepatoportoenterostomy for biliary 
atresia: a Delphi process and international expert panel 

Cholangitis definition and treatment protocol version 4.0 (16 Avril 2025) 
 
Ana M. Calinescu, Omid Madadi-Sanjani, Cara Mack, Richard Schreiber, Riccardo Superina, 
Deirdre Kelly, Claus Petersen, Barbara E. Wildhaber 
Journal of Clinical Medicine, 2021 – manuscript in progress 
 
 
Primary aim 
To assess the applicability of the definitions (Figure 1) for suspected and confirmed 
cholangitis. 
 
Primary analysis 
Prospective application of diagnostic criteria to the patients suspected of acute cholangitis on a 
clinical basis.  
 
Inclusion 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 (please 
do NOT exclude these patients!), (2) cholangitis is finally confirmed. 
 
Exclusion criteria: recurrent cholangitis, cholangitis >1 year after Kasai. 
 
In this study, patients were considered to have had an acute cholangitis based on three criteria: 
 
1. clinical confirmation by clinicians. 
2. clinical remission due to antimicrobial therapy. 
3. laboratory values improvement after antimicrobial therapy. 
 
 
 
 
 
*  Cholangitis within the 1st year after Kasai
**Definition for abdominal discomfort: vomiting, poor feeding, irritability
A. Clinical elements
•Fever and/or shivering
•Stool color change
•New/increasing jaundice
•Abdominal discomfort**
B. Laboratory and imaging elements
•Inflammatory response (WBC and/or CRP and/or 
PCT)
•Increased/increasing transaminases
•Increased/increasing GGT and/or bilirubin
•Bile lakes
Suspected Cholangitis: 
- Definition: one item in A + one item in B
- Treatment: 10 – 14 days
Confirmed Cholangitis: 
- Definition: two items in A + two items in B
or
“suspected cholangitis” + positive blood culture
- Treatment: 14 – 21 days
Peroral prophylaxisof cholangitis: 6 – 12 months

Cholangitis definition and treatment protocol version 4.0 (16 Avril 2025) 
 
Figure 1: definitions of suspected and confirmed cholangitis, used in this study. 
 
Bile lakes were defined as bile containing solitary or multiple cystic intrahepatic lesions 
following the portal tracts. 
 
 
Secondary aims 
● Validate the duration of treatment for suspected and confirmed cholangitis 
 
Analysis 
Assess the actual duration of treatment and compare it with the proposed duration of antibiotic 
treatment 
 
Data will only be released at regional and country-level. No hospital-level outcomes data will 
be published. 
 
Methodology 
● Prospective observational feasibility study. 
● All hospitals caring for patients with biliary atresia are eligible to participate. 
● Collaborators will collect data on all consecutive eligible cases.  
● Data will be completely anonymized and subjects cannot be re-identified. 
● A mini-team of around three collaborators will collect data over 12 months: 
○ The first day of data collection will be starting with 1st June 2025. 
○ Multiple mini-teams may participate at the same hospital. 
○ We suggest that at least one mini-team participating within your specialty should 
include a senior (consultant/ attending) doctor. 
 
Inclusion criteria 
● Any biliary atresia patient within 1 year after Kasai suspected to have a cholangitis. 
● All connected specialties including: pediatric surgery, hepatology, pediatrics, emergency 
care, intensive care. 
● Outpatient clinic and inpatient included. 
 
Follow-up 
This is an observational study and no changes should be made to normal patient pathways, and no 
additional patient follow-up is required. Patients should have clinical follow-up as per normal 
practice at their hospital. Follow-up data should be entered at the end of the study period following 
first presentation based on written patient notes, computer records, or telephone/in-person follow-
up. 
 
 

Cholangitis definition and treatment protocol version 4.0 (16 Avril 2025) 
 
Data collection 
Data will be collected and stored online through a secure server running the Research Electronic 
Data Capture (REDCap) web application. REDCap allows collaborators to enter and store data in 
a secure system. A designated collaborator at each participating site will be provided with REDCap 
project server login details, allowing them to securely submit data on to the REDCap system. The 
REDCap server is managed by the Geneva University Hospitals, Switzerland. Only anonymized 
data will be uploaded to the database. No patient identifiable data will be collected. The study will 
be carried out in accordance with national and international guidelines, as well as the basic 
principles of the protection of the rights and dignity of Human Beings, as set out in the Helsinki 
Declaration (75th Assembly Fortaleza, Brazil, in October 2024), and according to locally 
applicable legislation. 
 
Local approvals 
Principal investigators at each participating site is responsible for obtaining necessary local 
approvals in line with their hospital’s regulations. Collaborators will be required to confirm that a 
local approval is in place at the time of uploading each patient record to the study database. 
Whatever approvals pathway is followed, it should be highlighted that this is an investigator-led, 
non-commercial, observational (no changes to normal patient care) study which is extremely low 
risk, as only routinely available non-identifiable data will be collected. 
 
Possible pathways to register this study include: 
● Research (e.g. research ethics committee or institutional review board approvals). Written 
patient consent should only be taken if required by your local ethics committee. 
● Data from pre existing database 
● Service evaluation. 
● Clinical audit (e.g. approval process in the UK).  
 
Authorship 
Up to three collaborators may participate in each team that collects data over a 12-months period.  
Collaborators from each site who contribute patients will be recognized on any resulting 
publications as PubMed-citable co-authors.  
 
 
 
 
 
 
 
 
 
 

Cholangitis definition and treatment protocol version 4.0 (16 Avril 2025) 
 
Case Report Form 
 
Baseline 
Age  
< 1 month, 1 month, 2 months, 3 months, 4 months, 5 months, 6 
months, 7 months, 8 months, 9 months, 10 months, 11 months, 12 
months 
Age at Kasai 
< 4 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 
10 weeks, 11 weeks, 12 weeks, 13 weeks, 14 weeks, 15 weeks, 16 
weeks, >16 weeks 
Sex 
>Female 
>Male 
>Other 
Cholangitis diagnosis 
Age at cholangitis 
< 1 month, 1 month, 2 months, 3 months, 4 months, 5 months, 6 
months, 7 months, 8 months, 9 months, 10 months, 11 months, 12 
months, 13 months, 14 months, 15 months, 16 months, 17 months, 
18 months, 19 months, 20 months, 21 months, 22 months, 23 
months 
Were any of the following 
clinical elements present 
at the patients with 
suspected cholangitis 
(tick all that apply) 
>Fever and/or shivering* 
>Stool color change 
>New/increasing jaundice 
>Abdominal discomfort** 
* Body temperature > 38° 
** Vomiting, poor feeding, irritability 
Were any of the following 
laboratory and imaging 
elements present at the 
patients with suspected 
cholangitis 
(tick all that apply) 
>Inflammatory response (WBC and/or CRP and/or PCT) 
>Increased or increasing transaminases (1.5 VN) 
>Increased or increasing GGT (1.5 VN) and/or bilirubin  
>Bile lakes 
>Positive blood cultures 
 
Suspected cholangitis 
diagnosis according to 
the physician’s appraisal 
w/o using the study 
definitions 
>Yes 
>No 
>If no: final diagnosis:………………… 
Confirmed cholangitis 
diagnosis according to 
the physician’s appraisal 
w/o using the study 
definitions 
>Yes 
>No  
>If no: final diagnosis:…………………. 
 

Cholangitis definition and treatment protocol version 4.0 (16 Avril 2025) 
 
If confirmed Cholangitis 
 
How was the diagnosis 
made? 
(tick all that apply) 
>Clinical diagnosis 
>Responded to antibiotic treatment 
>Purulent bile discharge if bile lake drained 
>On liver biopsy if biopsy performed 
>Other (please specify): ……………….. 
Were the study 
definitions for confirmed 
and suspected 
cholangitis used? 
>Yes 
>No 
What were the limitations 
you encountered in 
applying the provided 
definitions? 
……………………………………………. 
……………………………………………. 
Cholangitis prophylaxis and treatment 
Was the patient on 
prophylaxis when 
cholangitis occurred? 
>Yes 
>No 
 
When was prophylaxis 
initiated? 
>After Kasai 
>After the 1st cholangitis episode 
>After the 2nd cholangitis episode 
>Other (please specify): ……………….. 
What was the intended 
duration for prophylaxis 
after Kasai? 
>3-6 months 
>6-9 months 
>9-12 months 
>More than 12 months 
>Other: please specify 
If yes, what treatment 
was the patient getting? 
>Sulfamethoxazole and trimethoprim 
>Oral cephalosporin 
>Amoxicillin and clavulanic acid 
>Other: please specify …… 
What treatment did the 
patient get for this 
cholangitis episode? 
>Tazobactam and piperacillin 
>Ceftriaxone 
>Ciprofloxacin 
>Other: please specify ….. 
For how long was the 
patient treated? 
>Less than1 week 
>10 days 
>2 weeks 
>3 weeks 
>More than 3 weeks 

Cholangitis definition and treatment protocol version 4.0 (16 Avril 2025) 
 
Was the patient 
prescribed prophylaxis 
after this cholangitis 
episode? 
>Yes 
>No 
What was the intended 
duration for prophylaxis 
after this episode of 
cholangitis? 
>3-6 months 
>6-9 months 
>9-12 months 
>More than 12 months 
>Other: please specify 
Did the patient 
experience a new 
cholangitis episode 
during the study period? 
>Yes 
>No 
What was the patient ‘s 
status after this 
cholangitis episode? 
 
 
 
 
>Dead 
>Alive 
General information 
How many biliary atresia 
patients were diagnosed 
during the last 12 months 
in your center? 
 
>……………………………………………. 
 
Do you have other 
comments or 
suggestions? 
>………………………………………………