First Human Use of a New Robotic-Assisted Fiber Optic Sensing Navigation System for Small Peripheral Pulmonary Nodules
First Human Use of a New Robotic-Assisted Fiber Optic Sensing Navigation System for Small Peripheral Pulmonary Nodules
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DOI：
10.1159/000498951
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发表时间：
2019-01-01
期刊：
影响因子：
3.7
通讯作者：
Sung, Rthur Wai
中科院分区：
文献类型：
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作者：
Fielding, David I. K.;Bashirzadeh, Farzad;Sung, Rthur Wai
背景：我们测试了一种新的研究性机器人辅助支气管镜系统，该系统带有远程控制导管，可在实时可视化和导管远端关节的情况下实时驱动来进入小外周支气管。独特的导管一旦位于活检位置就保持静止。目的：本研究的主要目的是评估新型形状感知机器人支气管镜系统的安全性和可行性，以通过支气管镜接近并促进 1-3 cm 的小外周肺结节的采样。次要目标包括评估与使用新型机器人支气管镜系统相关的程序特征和早期性能趋势。方法：根据单一中心的研究资格标准招募受试者。导航路径是使用术前 CT 扫描半自动创建的。在导航到显示目标的过程中实时使用实际和虚拟支气管的同时（实时）查看。使用支气管内超声微型探头来确认病变位置。专门设计用于适应经支气管针抽吸中的小弯曲半径的柔性 19 至 23 G 针与传统活检工具一起使用。登记受试者在手术后完成长达 6 个月的随访。结果：该研究包括 29 名受试者，其轴向、冠状和矢状面的平均病变大小分别为 12.2 +/- 4.2、12.3 +/- 3.3 和 11.7 +/- 4.1 毫米。 41.4% 的病例没有 CT 支气管征。 96.6%的情况达到了目标，并获得了样品。手术过程中没有观察到与设备相关的不良事件，也没有出现气胸或过度出血的情况。早期表现趋势显示总体诊断率为 79.3%，恶性肿瘤诊断率为 88%。结论：这种新型机器人辅助支气管镜系统在连续可视化下安全地导航到非常小的外周气道，并通过保持静态位置，为小型孤立性肺结节的活检提供了独特的采样能力。 (C) 2019 S. Karger AG，巴塞尔
Background: We tested a new, investigational robotic-assisted bronchoscope system with a remotely controlled catheter to access small peripheral bronchi with real-time driving under live visualization and distal tip articulation of the catheter. The unique catheter remains stationary once located at the biopsy position. Objectives: The primary objectives of this study were to evaluate the safety and feasibility of a new shape-sensing robotic bronchoscope system to bronchoscopically approach and facilitate the sampling of small peripheral pulmonary nodules of 1-3 cm. Secondary objectives included evaluating procedural characteristics and early performance trends associated with the use of the new robotic bronchoscope system. Methods: Subjects were enrolled according to study eligibility criteria at a single center. Navigation pathways were semi-automatically created using pre-procedure CT scans. Simultaneous (real-time) viewing of actual and virtual bronchi was used real time during navigation to the displayed target. An endobronchial ultrasound mini-probe was used to confirm lesion location. Flexible 19- to 23-G needles specifically designed to accommodate tight bend radii in transbronchial needle aspiration were used along with conventional biopsy tools. Enrolled subjects completed follow-up visits up to 6 months after the procedure. Results: The study included 29 subjects with a mean lesion size of 12.2 +/- 4.2, 12.3 +/- 3.3, and 11.7 +/- 4.1 mm in the axial, coronal, and sagittal planes, respectively. The CT bronchus sign was absent in 41.4% of cases. In 96.6% of cases, the target was reached, and samples were obtained. No device-related adverse events and no instances of pneumothorax or excessive bleeding were observed during the procedure. Early performance trends demonstrated an overall diagnostic yield of 79.3% and a diagnostic yield for malignancy of 88%. Conclusion: This new robotic-assisted bronchoscope system safely navigated to very small peripheral airways under continuous visualization, and through maintenance of a static position, it provides a unique sampling capability for the biopsy of small solitary pulmonary nodules. (C) 2019 S. Karger AG, Basel