{
  "abstract": "Introduction Sarcoidosis frequently involves intrathoracic lymph nodes and lung parenchyma and requires histological confirmation for diagnosis. Although endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is recommended for obtaining mediastinal samples, its diagnostic yield frequently necessitates additional transbronchial lung biopsy (TBLB) and/or endobronchial biopsy (EBB). EBUS transbronchial mediastinal cryobiopsy (EBUS-TBMC) can yield larger, well-preserved tissue samples than EBUS-TBNA alone. However, whether EBUS-TBMC alone is equivalent to conventional multimodal sampling (EBUS-TBNA combined with TBLB and/or EBB), and whether TBLB and EBB provide incremental diagnostic value when added to EBUS-TBMC, is still unclear.Methods and analysis In this study, 410 patients with suspected stage I/II sarcoidosis will be randomly assigned in a 1:1 ratio to either the EBUS-TBMC or EBUS-TBNA group. All participants will then undergo TBLB and EBB. The primary outcome will be the granuloma detection rate. The diagnostic sensitivity, negative predictive value and procedure-related complications will be selected for secondary outcomes. Statistical analysis will be performed using SPSS V.24.0, with non-inferior testing for the primary comparison.Ethics and dissemination Approval for this DETECTION-SAR-II trial was obtained by the China-Japan Friendship Hospital Ethics Committee (Ethics number: 2025-KY-075). Participants will be fully informed of objectives, protocol and potential risks of the study before enrolment and will provide written informed consent.Trial registration number NCT07246876.",
  "authors": [
    {
      "affiliations": [
        "National Center for Respiratory Medicine",
        "State Key Laboratory of Respiratory Health and Multimorbidity",
        "National Clinical Research Center for Respiratory Diseases",
        "Institute of Respiratory Medicine, Chinese Academy of Medical Sciences & Peking Union Medical College",
        "Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China"
      ],
      "name": "Ziwen Zheng"
    },
    {
      "affiliations": [
        "Henan Institute of Interconnected Intelligent Health, Henan Key Laboratory of Chronic Disease Prevention and Therapy & Intelligent Health Management, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China"
      ],
      "name": "Huaqi Wang"
    },
    {
      "affiliations": [
        "National Center for Respiratory Medicine",
        "State Key Laboratory of Respiratory Health and Multimorbidity",
        "National Clinical Research Center for Respiratory Diseases",
        "Institute of Respiratory Medicine, Chinese Academy of Medical Sciences & Peking Union Medical College",
        "Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China"
      ],
      "name": "Junwei Guo"
    },
    {
      "affiliations": [
        "Department of Respiratory and Critical Care Medicine, Zhengzhou University People’s Hospital, Henan Provincial People's Hospital, Zhengzhou, Henan, China"
      ],
      "name": "Quncheng Zhang"
    },
    {
      "affiliations": [
        "Department of Interventional Pulmonology and Endoscopic Diagnosis and Treatment Center, Anhui Chest Hospital, Hefei, China"
      ],
      "name": "Fei Tang"
    },
    {
      "affiliations": [
        "Shandong Provincial Public Health Clinical Center, Jinan, Shandong, China"
      ],
      "name": "Li Xu"
    },
    {
      "affiliations": [
        "National Center for Respiratory Medicine",
        "State Key Laboratory of Respiratory Health and Multimorbidity",
        "National Clinical Research Center for Respiratory Diseases",
        "Institute of Respiratory Medicine, Chinese Academy of Medical Sciences & Peking Union Medical College",
        "Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China"
      ],
      "name": "Ming-Ming Deng"
    },
    {
      "affiliations": [
        "Department of Pneumology and Critical Care Medicine, Thoraxklinik, and Translational Lung Research Centre Heidelberg, University of Heidelberg, Heidelberg, Germany"
      ],
      "name": "Felix Herth"
    },
    {
      "affiliations": [
        "Department of Diseases of the Thorax, GB Morgagni Hospital, Forlì, Italy",
        "Department Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus, Denmark"
      ],
      "name": "Venerino Poletti"
    },
    {
      "affiliations": [
        "National Center for Respiratory Medicine",
        "State Key Laboratory of Respiratory Health and Multimorbidity",
        "National Clinical Research Center for Respiratory Diseases",
        "Institute of Respiratory Medicine, Chinese Academy of Medical Sciences & Peking Union Medical College",
        "Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China"
      ],
      "name": "Gang Hou"
    }
  ],
  "title": "Diagnostic Value of EBUS-guided Transbronchial MEdiastinal Cryobiopsy versus ConvenTIONal Bronchoscopic Approaches for Intrathoracic Stage I/II SARcoidosis: protocol for a randomised controlled trial (DETECTION-SAR-II)",
  "uid": "7496086e-36e5-5dfe-b069-e64e0a6b1a63"
}