Zheng Xiaoxuan, Zhong Changhao, Xie Fangfang, Li Shiyue, Wang Guiqi, Zhang Lei, Sun Jiayuan
Department of Respiratory Endoscopy and Department of Respiratory and Critical Care Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai Engineering Research Center of Respiratory Endoscopy, Shanghai, China.
State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
Respirology. 2023 Apr;28(4):389-398. doi: 10.1111/resp.14405. Epub 2022 Nov 10.
Transbronchial sampling of peripheral pulmonary lesions (PPLs) is routinely performed under fluoroscopy. However, advanced ancillary techniques have become available, such as virtual bronchoscopic navigation (VBN) and radial endobronchial ultrasound with a guide sheath (rEBUS-GS). This study was performed to determine whether the diagnostic utility of VBN and rEBUS with a GS is similar with or without fluoroscopy.
This multicenter non-inferiority trial randomized patients to a VBN-rEBUS-GS with or without fluoroscopy group at three centres. The primary endpoint was the diagnostic yield. The secondary endpoints were the time for rEBUS, GS, and the total operation. Complications were also recorded.
Four hundred and ninety-six subjects were assessed and 426 subjects were included in the analysis (212 in non-fluoroscopy-guided-group and 214 in fluoroscopy-guided-group). The diagnostic yield in the non-fluoroscopy-guided-group (84.0%) was not inferior to that in the fluoroscopy-guided-group (84.6%), with a diagnostic difference of -0.6% (95% CI: -6.4%, 5.2%). Multivariable analysis confirmed that bronchus sign and lesion nature were valuable diagnostic predictors in non-fluoroscopy-guided-group. The non-fluoroscopy-guided-group had shorter rEBUS, GS, and total operation time. No severe complications occurred in either group.
Transbronchial diagnosis of PPLs suspicious of malignancy and presence of a bronchus leading to or adjacent to lesions using VBN-rEBUS-GS without fluoroscopy is a safe and effective method that is non-inferior to VBN-rEBUS-GS with fluoroscopy. Bronchus leading to lesions and malignant nature are associated with high diagnostic yield in VBN-rEBUS-GS without fluoroscopy for the diagnosis of PPLs.
外周肺病变（PPL）的经支气管采样通常在荧光透视引导下进行。然而，诸如虚拟支气管镜导航（VBN）和带引导鞘的径向支气管内超声（rEBUS-GS）等先进辅助技术已可应用。本研究旨在确定VBN联合GS以及rEBUS在有无荧光透视引导下的诊断效用是否相似。
这项多中心非劣效性试验将患者随机分为三个中心的有或无荧光透视引导的VBN-rEBUS-GS组。主要终点是诊断率。次要终点是rEBUS、GS及总操作时间。同时记录并发症情况。
共评估了496名受试者，426名受试者纳入分析（非荧光透视引导组212名，荧光透视引导组214名）。非荧光透视引导组的诊断率（84.0%）不低于荧光透视引导组（84.6%），诊断差异为-0.6%（95%CI：-6.4%，5.2%）。多变量分析证实，支气管征和病变性质在非荧光透视引导组中是有价值的诊断预测指标。非荧光透视引导组的rEBUS、GS及总操作时间更短。两组均未发生严重并发症。
对于可疑恶性的PPL且病变有或毗邻导致病变的支气管，使用无荧光透视引导的VBN-rEBUS-GS进行经支气管诊断是一种安全有效的方法，不劣于有荧光透视引导的VBN-rEBUS-GS。在无荧光透视引导的VBN-rEBUS-GS诊断PPL中，导致病变的支气管和恶性性质与高诊断率相关。
