Definition for Biliary Atresia Associated Cholangitis After Surgery

Sponsor
Nanjing Children's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05464303
Collaborator
(none)
500
1
5.6
90.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Intravenous Antibodies

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Establishment and Validation of a Standardized Definition for Biliary Atresia Associated Cholangitis After Hepatic Portoenterostomy
Actual Study Start Date :
Jul 15, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Postoperative cholangitis

Patients who had conducted kasai procedure and suffered from postoperative cholangitis after surgery

Drug: Intravenous Antibodies
Treatment is usually performed with sensitive third-generation cephalosporins, and medication is adjusted according to blood culture results

None postoperative cholangitis

Patients who had conducted kasai procedure and followed up in a clinic,at which time they didn't present signs of cholangitis

Outcome Measures

Primary Outcome Measures

  1. Diagnostic cholangitis score [Two years]

    The values of the two groups' scores were calculated separately

Secondary Outcome Measures

  1. Score estimates for treatment of cholangitis [Two years]

    In the cholangitis group, the correlation between evaluation score and treatment was studied

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 16 Years
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 NJMU Nanjing Jiangsu China

Sponsors and Collaborators

  • Nanjing Children's Hospital

Investigators

  • Study Chair: Tang weibing, Dr, Nanjing Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weibing Tang, Dr, Nanjing Children's Hospital
ClinicalTrials.gov Identifier:
NCT05464303
Other Study ID Numbers:
  • ERBAAC
First Posted:
Jul 19, 2022
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2022