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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03842150
Enrollment
400
Registered
2019-02-15
Start date
2014-06-01
Completion date
2025-12-31
Last updated
2022-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Atresia, Infantile Hepatitis Syndrome, Neonatal Cholestasis

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.

Interventions

DIAGNOSTIC_TESTbiliary 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.

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 3 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Development and Validation a Screening Score for the biliary atresia in infantile cholestasis1 weeksDeveloped 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.

Countries

China

Contacts

Primary ContactYongjun Zhang, doctor
zhangyongjun@sjtu.edu.cn+8602125078310

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026