Deng Ming-Ming, Yang Zhen, Zhong Changhao, Zheng Ziwen, Tong Run, Zhou Guowu, Li Xuelian, Zhao Ling, Herth Felix J F, Hou Gang
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.
Department of Respiratory Medicine, Eighth Medical Centre of Chinese People's Liberation Army General Hospital, Beijing, China.
BMJ Open. 2025 Sep 23;15(9):e096871. doi: 10.1136/bmjopen-2024-096871.
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.
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 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.
www.
gov (NCT06262620).
由于各种潜在疾病，纵隔和/或肺门淋巴结肿大（MHL）的检出率日益增加。包括支气管内超声引导下经支气管针吸活检（EBUS-TBNA）、经支气管纵隔冷冻活检（TBMC）和经支气管钳夹活检（TBFB）在内的微创活检技术是常用的诊断工具。然而，它们的安全性和诊断效率仍不明确。本试验旨在比较这三种技术的诊断率和安全性。
本研究是一项三臂、平行设计、随机对照试验，纳入了从多个医疗中心招募的972例成年MHL患者。参与者将被随机分配到EBUS-TBNA组、经隧道TBMC组或经隧道TBFB组。主要结局是诊断率，次要结局包括诊断敏感性、样本质量和与操作相关的并发症。将使用适当的方法进行统计分析。采用独立样本χ²检验来检验诊断率和与操作相关并发症发生率的差异。
已获得中日友好医院伦理委员会的伦理批准（2022-KY-194）。在所有患者或其监护人入选研究之前，将获得他们的书面知情同意书。本研究将按照《赫尔辛基宣言》和国际协调理事会《药物临床试验质量管理规范指南》确立的原则进行。
