{
  "abstract": "Introduction Mediastinal and/or hilar lymphadenopathy (MHL) is increasingly identified owing to various underlying conditions. Minimally invasive biopsy techniques, including endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), transbronchial mediastinal cryobiopsy (TBMC) and transbronchial forceps biopsy (TBFB), are common diagnosis tools. However, their safety and diagnostic efficiency remain unclear. This trial aims to compare the diagnostic yield and safety of these three techniques.Methods and analysis This study is a three-arm, parallel-design, randomised controlled trial involving 972 adult patients with MHL recruited from multiple medical centres. Participants will be randomly assigned to the EBUS-TBNA, TBMC via a tunnel or TBFB via a tunnel group. The primary outcome is diagnostic yield, and the secondary outcomes include diagnostic sensitivity, sample quality and procedure-related complications. Statistical analyses will be conducted using the appropriate methods. An independent sample χ² test will be used to test the differences in the diagnostic yield and incidence of procedure-related complications.Ethics and dissemination Ethics approval was obtained from the China-Japan Friendship Hospital Ethics Committee (2022-KY-194).Written informed consent will be obtained from all patients or their guardians before their enrolment in the study. This study will be conducted per the principles established in the Declaration of Helsinki and the International Council for Harmonisation Guidelines for Good Clinical Practice.Trial registration number www.clinicaltrials.gov (NCT06262620).",
  "authors": [
    {
      "affiliations": [
        "National Centre for Respiratory Medicine",
        "State Key Laboratory of Respiratory Health and Multimorbidity",
        "National Clinical Research Centre for Respiratory Diseases",
        "Institute of Respiratory Medicine, Chinese Academy of Medical Sciences",
        "Department of Pulmonary and Critical Care Medicine, Centre of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China"
      ],
      "name": "Ming-ming Deng"
    },
    {
      "affiliations": [
        "Department of Respiratory Medicine, Eighth Medical Centre of Chinese People’s Liberation Army General Hospital, Beijing, China"
      ],
      "name": "Zhen Yang"
    },
    {
      "affiliations": [
        "Guangzhou Institute of Respiratory Health, State Key Laboratory of Respiratory Disease, National Clinical Research Centre for Respiratory Disease, National Centre for Respiratory Medicine, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China"
      ],
      "name": "Changhao Zhong"
    },
    {
      "affiliations": [
        "National Centre for Respiratory Medicine",
        "State Key Laboratory of Respiratory Health and Multimorbidity",
        "National Clinical Research Centre for Respiratory Diseases",
        "Institute of Respiratory Medicine, Chinese Academy of Medical Sciences",
        "Department of Pulmonary and Critical Care Medicine, Centre of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China",
        "China-Japan Friendship Hospital (Institute of Clinical Medical Sciences), Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China"
      ],
      "name": "Ziwen Zheng"
    },
    {
      "affiliations": [
        "National Centre for Respiratory Medicine",
        "State Key Laboratory of Respiratory Health and Multimorbidity",
        "National Clinical Research Centre for Respiratory Diseases",
        "Institute of Respiratory Medicine, Chinese Academy of Medical Sciences",
        "Department of Pulmonary and Critical Care Medicine, Centre of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China"
      ],
      "name": "Run Tong"
    },
    {
      "affiliations": [
        "National Centre for Respiratory Medicine",
        "State Key Laboratory of Respiratory Health and Multimorbidity",
        "National Clinical Research Centre for Respiratory Diseases",
        "Institute of Respiratory Medicine, Chinese Academy of Medical Sciences",
        "Department of Pulmonary and Critical Care Medicine, Centre of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China"
      ],
      "name": "Guowu Zhou"
    },
    {
      "affiliations": [
        "Department of Epidemiology, School of Public Health, China Medical University, Shenyang, Liaoning, China"
      ],
      "name": "Xuelian Li"
    },
    {
      "affiliations": [
        "Department of Pathology, China-Japan Friendship Hospital, Beijing, China"
      ],
      "name": "Ling Zhao"
    },
    {
      "affiliations": [
        "Department of Pneumology and Critical Care Medicine, Thoraxklinik, and Translational Lung Research Centre Heidelberg, University of Heidelberg, Heidelberg, Germany"
      ],
      "name": "Felix J F Herth"
    },
    {
      "affiliations": [
        "National Centre for Respiratory Medicine",
        "State Key Laboratory of Respiratory Health and Multimorbidity",
        "National Clinical Research Centre for Respiratory Diseases",
        "Institute of Respiratory Medicine, Chinese Academy of Medical Sciences",
        "Department of Pulmonary and Critical Care Medicine, Centre of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China"
      ],
      "name": "Gang Hou"
    }
  ],
  "title": "Comparison of diagnostic yield and safety of three endobronchial ultrasound-guided transbronchial biopsy techniques in diagnosing patients with mediastinal/hilar lymphadenopathy: a protocol of multicentre randomised trial in China",
  "uid": "a0a4c654-b6b5-5c8f-bd55-4d816113f4df"
}