一项多中心随机对照试验的研究设计，该试验旨在评估与无荧光透视的细支气管镜相比，超细支气管镜对周围型肺部病变的诊断价值。
Study design for a multicenter, randomized controlled trial evaluating the diagnostic value of ultrathin bronchoscope compared to thin bronchoscope without fluoroscopy for peripheral pulmonary lesions.
作者信息
Feng Xintong, Zhang Qin, Luo Fengming, Zhang Xiaoju, Zhang Lei, Xie Fangfang, Sun Jiayuan, Li Shiyue
机构信息
Department of Respiratory Endoscopy, Department of Respiratory and Critical Care Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.
Shanghai Engineering Research Center of Respiratory Endoscopy, Shanghai, China.
出版信息
J Thorac Dis. 2022 May;14(5):1663-1673. doi: 10.21037/jtd-22-20.
BACKGROUND
Ultrathin bronchoscope (UTB) with a 3.0-mm outer diameter and a 1.7-mm working channel currently appeared as a potential tool for better biopsy and diagnosis of peripheral pulmonary lesions (PPLs) by accessing more distal bronchus. However, published research is primarily limited to diagnosis value of UTB for PPLs with fluoroscopy, the value of UTB compared with thin bronchoscope (TB) without fluoroscopy guidance has not been determined yet.
METHODS
We design a prospective, randomized, controlled, non-inferior, multicenter study aiming to evaluate the diagnostic value and safety of UTB for PPLs with the guidance of virtual bronchoscopic navigation (VBN) combined with endobronchial ultrasound (EBUS) without fluoroscopy by comparing to TB. The study aims to enroll 578 patients presenting for evaluation of PPLs at five clinical sites in China. Subjects will be randomized to UTB-VBN-EBUS group, TB-VBN-EBUS-guide sheath (GS) group, and TB-VBN-EBUS-non-GS group. Primary endpoint is the diagnostic yield of PPLs. The total examination time, duration of finding lesions, the proportion of lesions visible by radial EBUS, factors affecting the diagnostic yield, difference in the bronchus level reached with the bronchoscope, difference in diagnostic yield, and complication rate will be determined as secondary endpoints. The primary endpoint will be followed-up at least 6-month post-procedure and 1-month post-procedure for safety endpoint.
DISCUSSION
Study enrollment began in March 2021. Our preliminary experience reveals that UTB is a powerful tool in the diagnosis of PPLs even without fluoroscopy. The results of the current study will compensate the limitations of the previous research, further provide evidence of UTB in diagnosing PPLs without fluoroscopy.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04571476. Registered on 30 September 2020.
背景
外径3.0毫米、工作通道1.7毫米的超薄支气管镜（UTB）目前似乎是一种通过进入更远端支气管来更好地活检和诊断周围型肺病变（PPL）的潜在工具。然而，已发表的研究主要限于UTB在荧光透视引导下对PPL的诊断价值，UTB与无荧光透视引导的细支气管镜（TB）相比的价值尚未确定。
方法
我们设计了一项前瞻性、随机、对照、非劣效、多中心研究，旨在通过与TB比较，评估在虚拟支气管镜导航（VBN）联合支气管内超声（EBUS）且无荧光透视引导下UTB对PPL的诊断价值和安全性。该研究旨在纳入在中国五个临床地点就诊以评估PPL的578例患者。受试者将被随机分为UTB-VBN-EBUS组、TB-VBN-EBUS引导鞘（GS）组和TB-VBN-EBUS非GS组。主要终点是PPL的诊断率。总检查时间、发现病变的持续时间、径向EBUS可见病变的比例、影响诊断率的因素、支气管镜到达的支气管水平差异、诊断率差异和并发症发生率将被确定为次要终点。主要终点将在术后至少6个月和术后1个月进行随访以评估安全终点。
讨论
研究入组于2021年3月开始。我们的初步经验表明，即使没有荧光透视，UTB也是诊断PPL的有力工具。本研究结果将弥补先前研究的局限性，进一步提供UTB在无荧光透视下诊断PPL的证据。
试验注册
ClinicalTrials.gov NCT04571476。于2020年9月30日注册。
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