Definition for Biliary Atresia Associated Cholangitis After Surgery

Establishment and Validation of a Standardized Definition for Biliary Atresia Associated Cholangitis After Hepatic Portoenterostomy

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 Overview

• Status: Recruiting
• Conditions: Cholangitis; Biliary Atresia
• Intervention / Treatment: Drug: Intravenous Antibodies

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Xie Hua, Dr; Phone Number: +8613611573952; Email: xiehua3955@126.com
• Study Contact Backup: Name: Lu changgui, Dr; Phone Number: +8613611573952

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • NJMU
      • Contact: Xie Hua, Dr; Phone Number: +8613611573952; Email: xiehua3955@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic cholangitis score	The values of the two groups' scores were calculated separately	Two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score estimates for treatment of cholangitis	In the cholangitis group, the correlation between evaluation score and treatment was studied	Two years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Biliary Tract Diseases; Bile Duct Diseases; Digestive System Abnormalities; Cholangitis; Biliary Atresia; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin
• Other Study ID Numbers: ERBAAC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No