{
  "abstract": "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.",
  "authors": [
    {
      "affiliations": [
        "Shanghai Institute of Infectious Disease and Biosecurity, Children’s Hospital, Fudan University, Shanghai, China"
      ],
      "name": "Jin Zhou"
    },
    {
      "affiliations": [
        "Department of Ultrasound, Shanghai Changning Maternity and Infant Health Hospital, East China Normal University, Shanghai, China"
      ],
      "name": "Yuqing Zhou"
    },
    {
      "affiliations": [
        "Department of Obstetrics, Shenzhen Maternity and Child Healthcare Hospital, Southern Medical University, Guangzhou, Guangdong, China"
      ],
      "name": "Xiaoxia Wu"
    },
    {
      "affiliations": [
        "Ultrasound Department of Affiliated Hospital of Maternal, Child Health Hospital of Nantong University, Affiliated Maternity and Child Health Care Hospital of Nantong University, Nantong, Jiangsu, China"
      ],
      "name": "Jian Xu"
    },
    {
      "affiliations": [
        "International Peace Maternity and Child Health Hospital, Shanghai Jiao Tong University School of Medicine, China Welfare Institute International Peace Maternity and Child Health Hospital, Shanghai, China"
      ],
      "name": "Yanlin Wang"
    },
    {
      "affiliations": [
        "Department of Obstetrics, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China"
      ],
      "name": "Yu Xiong"
    },
    {
      "affiliations": [
        "Shanghai Key Laboratory of Maternal Fetal Medicine, Department of Fetal Medicine & Prenatal Diagnosis Center, Shanghai First Maternity and Infant Hospital, School of Medicine, Tongji University, Shanghai, China"
      ],
      "name": "Gang Zou"
    },
    {
      "affiliations": [
        "Department of Ultrasound, Obstetrics and Gynecology, Hospital of Fudan University, Shanghai, China"
      ],
      "name": "Yingliu Yan"
    },
    {
      "affiliations": [
        "Department of Pediatric Surgery, Children’s Hospital of Fudan University, Shanghai, China"
      ],
      "name": "Jingying Jiang"
    },
    {
      "affiliations": [
        "Department of Pediatric Surgery, Children’s Hospital of Fudan University, Shanghai, China"
      ],
      "name": "Yifan Yang"
    },
    {
      "affiliations": [
        "Department of Pediatric Surgery, Children’s Hospital of Fudan University, Shanghai, China"
      ],
      "name": "Chun Shen"
    },
    {
      "affiliations": [
        "Department of Clinical Epidemiology, Clinical Trial Unit, Children’s Hospital of Fudan University, Shanghai, China"
      ],
      "name": "Weili Yan"
    },
    {
      "affiliations": [
        "Shanghai Institute of Infectious Disease and Biosecurity, Children’s Hospital, Fudan University, Shanghai, China"
      ],
      "name": "Shan Zheng"
    }
  ],
  "title": "Prenatal biliary imaging for the diagnosis of biliary atresia: a protocol for a multicentre prospective diagnostic accuracy study",
  "uid": "99fef511-45f5-5dcc-a96f-6c2d282d43a5"
}