Definition for Biliary Atresia Associated Cholangitis After Surgery

Study Overview
=================
Brief Summary
-----------------
Cholangitis is the most common postoperative complication of biliary atresia, with a reported incidence of 40-90%, which seriously affects the surgical effect, survival rate and the quality of life and prognosis of patients. Without of direct evidence, the diagnosis of cholangitis sometimes is difficult to make, thus most of them are diagnosed based on the symptoms of children. According to literature reports, different centers and regions have different diagnostic criteria for postoperative cholangitis after hepatic portoenterostomy, which has a great influence on the accuracy of the incidence rate and appropriate treatment of cholangitis, and also brings differences in the analysis of the causes and prognostic factors of cholangitis. Based on the above reasons, we used the Delphi method，in which worldwidely 48 experts participated in, to establish the diagnostic scoring system for postoperative cholangitis after biliary atresia. Now we aimed to verify the specificity and sensitivity of the new scoring system through clinical cases, in order to unify and standardize the diagnostic criteria and provide help for the diagnosis and treatment of cholangitis after biliary atresia.

Official Title
-----------------
Establishment and Validation of a Standardized Definition for Biliary Atresia Associated Cholangitis After Hepatic Portoenterostomy

Conditions
-----------------
Cholangitis, Biliary Atresia

Intervention / Treatment
-----------------
* Drug: Intravenous Antibodies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ① Admission time: 2019.01.01-2021.12.31; ② The first diagnosis after discharge was cholangitis Exclusion Criteria: ① Cholangitis after non-Kasai procedure; Postoperative cholangitis of biliary atresia not operated in the unit; ③ Patient has been treated in other hospitals during this episode; ④ The treatment period for cholangitis is not completed or the patient is discharged automatically.

Ages Eligible for Study
-----------------
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Postoperative cholangitis<br>Patients who had conducted kasai procedure and suffered from postoperative cholangitis after surgery | Drug: Intravenous Antibodies<br>* Treatment is usually performed with sensitive third-generation cephalosporins, and medication is adjusted according to blood culture results<br>|
| None postoperative cholangitis<br>Patients who had conducted kasai procedure and followed up in a clinic，at which time they didn't present signs of cholangitis | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic cholangitis score | The values of the two groups' scores were calculated separately | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score estimates for treatment of cholangitis | In the cholangitis group, the correlation between evaluation score and treatment was studied | Two years |