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

Biliary Atresia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03842150
• Other study ID #: XH-19-001
• Status: Recruiting
• Start date: June 1, 2014
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2021
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Yongjun Zhang, doctor
• Phone: +8602125078310
• Email: zhangyongjun[@]sjtu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Biliary Atresia
• Cholestasis
• Infantile Hepatitis Syndrome
• Neonatal Cholestasis

Intervention

Diagnostic Test:
• biliary atresia screen score
The investigators aim to develop a scoring system according to clinical, laboratory, imaging features of biliary atresia in the derivation dataset and tested in the validation datasets.

Locations

Country	Name	City	State
China	Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development and Validation a Screening Score for the biliary atresia in infantile cholestasis	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, ?-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.	1 weeks