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The Value of Prenatal Biliary Imaging Examination in the Diagnosis of Biliary Atresia: A Multicenter Clinical Study

The Value of Prenatal Biliary Imaging Examination in the Diagnosis of Biliary Atresia: A Multicenter Clinical Study - The Value of Prenatal Biliary Imaging Examination in the Diagnosis of Biliary Atresia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400087744
Enrollment
Unknown
Registered
2024-08-02
Start date
2024-08-05
Completion date
Unknown
Last updated
2024-08-05

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

Conditions

biliary atresia

Interventions

Gold Standard:The gold standard involves follow-up, surgical exploration and cholangiography when necessary. According to the gold standard, the postnatal outcome would be diagnosed as biliary atresia
Index test:The prenatal biliary imaging examination standards designed in the study, including prenatal ultrasound and magnetic resonance imaging examination. Details are provided in the study protoco

Sponsors

Children's Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: The fetuses whose prenatal imaging examinations are performed in seven cooperative hospitals in China according to the study protocol from August 05, 2024 to May 31, 2025, with guardians agreed with the study as well are included. The cooperative hospitals include Obstetrics and Gynecology Hospital of Fudan University, Shanghai First Maternity and Infant Hospital, International Peace Maternity and Child Health Hospital of China welfare institute, Shenzhen Maternity and Child Healthcare Hospital, Xiamen Maternal and Child Health Hospital, Nantong Maternal and Child Health Care Hospital, Shanghai Changning Maternity and Infant Health Hospital.

Exclusion criteria

Exclusion criteria: Termination of pregnancy.

Design outcomes

Primary

MeasureTime frame
sensitivity;specificity;positive predictive value;negative predictive value;odds of being affected given a positive result;

Secondary

MeasureTime frame
Kappa value;

Countries

China

Contacts

Public ContactShan Zheng

Children's Hospital of Fudan University

szheng@shmu.edu.cn+86 159 0089 8826

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026