Definition for Biliary Atresia Associated Cholangitis After Surgery

NCT05464303 | Unknown

• 1 other identifier: ERBAAC
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Atresia; Cholangitis

Outcome Measures

Primary Outcomes (1)

• Diagnostic cholangitis score

  The values of the two groups' scores were calculated separately

  Two years

Secondary Outcomes (1)

• Score estimates for treatment of cholangitis

  Two years

Study Arms (2)

Postoperative cholangitis

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

Drug: Intravenous Antibodies

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

Interventions

Intravenous Antibodies DRUG

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

Postoperative cholangitis

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients who had been conducted Kasai procedure have different outcomes. The clinical data of these patients who were diagnosed as cholangitis and were followed up in the clinic were collected in this study.

You may qualify if:

• ① Admission time: 2019.01.01-2021.12.31;
• ② The first diagnosis after discharge was cholangitis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Children's Hospital: lead

Study Sites (1)

NJMU

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Biliary Atresia; Cholangitis

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Tang weibing, Dr

  Nanjing Children's Hospital

  STUDY CHAIR

Central Study Contacts

Xie Hua, Dr

CONTACT

+8613611573952; xiehua3955@126.com

Lu changgui, Dr

CONTACT

+8613611573952

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 19, 2022
• Study Start: July 15, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-07

Locations

CN (1)