Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-01-02 @ 12:09 AM
Study NCT ID:
NCT05464303
Status:
UNKNOWN
Last Update Posted:
2022-07-19
First Post:
2022-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Definition for Biliary Atresia Associated Cholangitis After Surgery
Sponsor:
Nanjing Children's Hospital
Organization:
Study Overview
Official Title:
Establishment and Validation of a Standardized Definition for Biliary Atresia Associated Cholangitis After Hepatic Portoenterostomy
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: