First Human Use of a New Robotic-Assisted Fiber Optic Sensing Navigation System for Small Peripheral Pulmonary Nodules.

Autor:	Fielding DIK; Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia, d.i.k.fielding@optusnet.com.au., Bashirzadeh F; Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia., Son JH; Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia., Todman M; Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia., Chin A; Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia., Tan L; Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia., Steinke K; Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia., Windsor MN; Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia., Sung AW; Stanford University Medical Center, Stanford, California, USA.
Jazyk:	angličtina
Zdroj:	Respiration; international review of thoracic diseases [Respiration] 2019; Vol. 98 (2), pp. 142-150. Date of Electronic Publication: 2019 Jul 26.
DOI:	10.1159/000498951
Abstrakt:	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. (© 2019 S. Karger AG, Basel.)
Databáze:	MEDLINE
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