Prenatal biliary imaging for the diagnosis of biliary atresia: a protocol for a multicentre prospective diagnostic
Jin Zhou1, Yuqing Zhou2, Xiaoxia Wu3
1Shanghai Institute of Infectious Disease and Biosecurity, Children's Hospital, Fudan University, Shanghai, China.
Insights
Antenatal ultrasound may detect biliary atresia (BA) before birth. This study evaluates fetal biliary imaging for diagnosing BA, a serious infantile cholangiopathy, to improve early intervention.
Area of Science:
- Medical Imaging
- Pediatric Surgery
- Neonatal Care
Background:
- Biliary atresia (BA) is a severe infantile cholangiopathy necessitating early diagnosis and surgical treatment.
- Current screening methods for BA are initiated postnatally, limiting early detection.
- Antenatal imaging shows promise for BA detection due to evidence of prenatal onset, but high-quality data is limited.
Purpose of the Study:
- To assess the diagnostic accuracy of antenatal biliary imaging features for detecting biliary atresia (BA).
- To establish the performance of fetal ultrasound in identifying BA during pregnancy.
Main Methods:
- A multicentre, prospective cohort diagnostic accuracy study involving over 92,000 pregnancies.
- Index test: predefined imaging features of the fetal biliary system.
- Reference standard: postnatal clinical follow-up, surgical exploration, and intraoperative cholangiography.
Main Results:
- Diagnostic performance metrics including sensitivity, specificity, and predictive values will be calculated.
- A dual follow-up strategy balances feasibility and diagnostic rigor.
- Study aims to provide robust evidence on the utility of antenatal imaging for BA detection.
Conclusions:
- Antenatal imaging holds potential for early BA diagnosis.
- This study will clarify the role of fetal ultrasound in identifying BA.
- Improved prenatal detection can lead to timely surgical intervention for infants with BA.
Introduction:
Biliary atresia (BA) is a rare but serious infantile cholangiopathy requiring timely diagnosis and surgical intervention. However, current screening methods are limited by their postnatal initiation. By contrast, antenatal imaging is increasingly considered promising due to growing evidence of a prenatal onset of BA, although high-quality diagnostic evidence remains scarce. This study aims to evaluate the diagnostic performance of antenatal biliary imaging features for the detection of BA.
Methods And Analysis:
This is a multicentre, prospective cohort diagnostic accuracy study enrolling pregnant women undergoing routine prenatal ultrasound. The index test consists of predefined imaging features of the fetal biliary system. A minimum of 92 082 pregnancies will be screened and a dual follow-up strategy has been designed to balance feasibility and diagnostic rigour. All fetuses with positive index test findings, along with a 1:1 systematically sampled group of test-negative cases, will be included in a direct follow-up subset. The remainder will undergo indirect follow-up through health system linkage and outcome verification. The reference standard for diagnosing BA is based on postnatal clinical follow-up, supplemented by surgical exploration and intraoperative cholangiography when deemed necessary. Diagnostic performance will be assessed by calculating sensitivity, specificity, positive and negative predictive values.
Ethics And Dissemination:
The study has been approved by the Ethics Committee of Children's Hospital of Fudan University (number 2024-30). Findings will be disseminated through academic conferences and submitted for publication in peer-reviewed journals.
Trial Registration Number:
ChiCTR2400087744.