Development and Validation of a Screening Score for the Biliary Atresia in Infantile Cholestasis: A Prospective Study

Recruiting

• Conditions: Biliary Atresia; Infantile Hepatitis Syndrome; Neonatal Cholestasis
• Interventions: Diagnostic Test: biliary atresia screen score

• Registration Number: NCT03842150
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

Better survival and prognosis of biliary atresia (BA) depend on early diagnosis and timely Kasai portoenterostomy. Identifying BA from other causes of infantile cholestasis at early stage of the disease still remains a major challenge. In this study, the investigators aim to develop and validate a scoring system to screen BA in infants with cholestasis.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-01
• Study First Submitted: 2019-02-13
• Study First Submitted QC: 2019-02-13
• Study First Posted: 2019-02-15
• Status Verified: 2021-01
• Last Update Submitted: 2022-12-25
• Last Update Posted: 2022-12-28
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Clinical diagnosis of neonatal cholestasis Age at first visit less than 90 days after birth

Exclusion Criteria

Severe congenital malformation Subjects with missing data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
validation cohort	biliary atresia screen score	-
derivation cohort	biliary atresia screen score	-

Primary Outcome Measures

Name	Time	Method
Development and Validation a Screening Score for the biliary atresia in infantile cholestasis	1 weeks	Developed a scoring system according to clinical, laboratory, imaging features of BA and test it in the clinical work. The score system might including clay stool, γ-glutamyl transpeptadase, the results of ultrasound and subscales selected for logistic regression. The total score would sum all the subscales up.The investigators grade the patients with the cholestasis screen score to identify patients with biliary atresia. Patients with score ≤ 15 points considered to be the low-risk group, and patients with risk score \> 15 points considered the high-risk group, and the score model has no maximum or minimum value.

Trial Locations

Locations (1)

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China