Definition for Biliary Atresia Associated Cholangitis After Surgery

• Conditions: Cholangitis; Biliary Atresia
• Interventions: Drug: Intravenous Antibodies

• Registration Number: NCT05464303
• Lead Sponsor: Nanjing Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-07
• Study Start: 2022-07-15
• Study First Submitted: 2022-07-15
• Study First Submitted QC: 2022-07-15
• Last Update Submitted: 2022-07-15
• Study First Posted: 2022-07-19
• Last Update Posted: 2022-07-19
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Postoperative cholangitis	Intravenous Antibodies	Patients who had conducted kasai procedure and suffered from postoperative cholangitis after surgery

Primary Outcome Measures

Name	Time	Method
Diagnostic cholangitis score	Two years	The values of the two groups' scores were calculated separately

Secondary Outcome Measures

Name	Time	Method
Score estimates for treatment of cholangitis	Two years	In the cholangitis group, the correlation between evaluation score and treatment was studied

Trial Locations

Locations (1)

NJMU; 🇨🇳 Nanjing, Jiangsu, China