Establishment and Validation of a Standardized Definition for Biliary Atresia Associated Cholangitis After Hepatic Portoenterostomy
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Diagnostic cholangitis score
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- — to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Postoperative cholangitis
Patients who had conducted kasai procedure and suffered from postoperative cholangitis after surgery
Intervention: Intravenous Antibodies (Drug)
Outcomes
Primary Outcomes
Diagnostic cholangitis score
Time Frame: Two years
The values of the two groups' scores were calculated separately
Secondary Outcomes
- Score estimates for treatment of cholangitis(Two years)
Investigators
Weibing Tang
Dr
Nanjing Children's Hospital