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

NCT03842150 | Unknown

• 1 other identifier: XH-19-001
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Atresia; Neonatal Cholestasis; Infantile Hepatitis Syndrome

Outcome Measures

Primary Outcomes (1)

• 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, 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.

  1 weeks

Study Arms (2)

derivation cohort

Diagnostic Test: biliary atresia screen score

validation cohort

Diagnostic Test: biliary atresia screen score

Interventions

biliary atresia screen score DIAGNOSTIC_TEST

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.

derivation cohort; validation cohort

Eligibility Criteria

• Age: 1 Day - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

infants with cholestasis inclduing biliary atresia

You may qualify if:

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

You may not qualify if:

• Severe congenital malformation Subjects with missing data

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Conditions

Biliary Atresia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yongjun Zhang, doctor

CONTACT

+8602125078310; zhangyongjun@sjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 15, 2019
• Study Start: June 1, 2014
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 28, 2022

Record last verified: 2021-01

Locations

CN (1)