Trials / Unknown
UnknownNCT05464303
Definition for Biliary Atresia Associated Cholangitis After Surgery
Establishment and Validation of a Standardized Definition for Biliary Atresia Associated Cholangitis After Hepatic Portoenterostomy
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (estimated)
- Sponsor
- Nanjing Children's Hospital · Academic / Other
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Intravenous Antibodies | Treatment is usually performed with sensitive third-generation cephalosporins, and medication is adjusted according to blood culture results |
Timeline
- Start date
- 2022-07-15
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
- First posted
- 2022-07-19
- Last updated
- 2022-07-19
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05464303. Inclusion in this directory is not an endorsement.