研究动态
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无荧光下使用虚拟支气管镜导航和经导管支气管内超声检查技术诊断肺外周部位损伤并且有通向或邻近支气管的效果:一项随机非劣性试验。

Virtual bronchoscopic navigation and endobronchial ultrasound with a guide sheath without fluoroscopy for diagnosing peripheral pulmonary lesions with a bronchus leading to or adjacent to the lesion: A randomized non-inferiority trial.

发表日期:2022 Nov 10
作者: Xiaoxuan Zheng, Changhao Zhong, Fangfang Xie, Shiyue Li, Guiqi Wang, Lei Zhang, Jiayuan Sun
来源: RESPIROLOGY

摘要:

外周肺部病灶(PPLs)经常在透视下进行支气管肺活检。但是,现已出现了先进的辅助技术,例如虚拟支气管镜导航(VBN)和带引导套的径向内镜超声(rEBUS-GS)。本研究旨在确定VBN和GS伴随或不伴随透视在诊断效用方面是否相似。这项多中心非劣效性试验在三个中心随机病患分配到带或不带透视指导的VBN - rEBUS - GS组。主要终点是诊断收益。次要终点是rEBUS、GS和总手术时间。并记录并发症。共评估了496名受试者,其中426名受试者被纳入分析(212名在未伴随透视指导组,214名在伴随透视指导的组)。非透视指导组的诊断收益(84.0%)不劣于透视指导组的诊断收益(84.6%),且诊断差异为-0.6%(95% CI:-6.4%,5.2%)。多元分析确认支气管征和病变性质是非透视指导组有价值的诊断指标。非透视指导组的rEBUS、GS和总手术时间更短。两组均未发生严重并发症。使用VBN-rEBUS-GS无需透视,诊断可疑的PPLs恶性肿瘤及病变周围的支气管存在是一种安全有效的方法,且不劣于带透视的VBN-rEBUS-GS。支气管通向病变和恶性性质是用VBN-rEBUS-GS无需透视诊断PPLs的高诊断收益相关因素。 © 2022亚太呼吸学会。
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.© 2022 Asian Pacific Society of Respirology.