Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter Pilot and Feasibility Study (BENEFIT)

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BACKGROUND: The diagnosis of peripheral pulmonary lesions (PPL) continues to present clinical challenges. Despite extensive experience with guided bronchoscopy, the diagnostic yield has not significantly improved. Robotic assisted bronchoscopic platforms have been developed to potentially improve the diagnostic yield for PPL. Presently, limited data exists evaluating the performance of robotic systems in live human subjects.

RESEARCH QUESTION: What is the safety and feasibility of robotic assisted bronchoscopy in patients with peripheral pulmonary lesions?

STUDY DESIGN AND METHODS: This was a prospective, multicenter pilot and feasibility study using a robotic bronchoscopic system with a mother-daughter configuration in patients with PPL 1-5cm in size. The primary endpoints were successful lesion localization using radial probe endobronchial ultrasound (R-EBUS) and incidence of procedure related adverse events. Robotic bronchoscopy was performed in patients using direct visualization, electromagnetic navigation and fluoroscopy. Following utilization of R-EBUS, transbronchial needle aspiration (TBNA) was performed. Rapid on-site evaluation (ROSE) was utilized on all cases. TBNA alone was sufficient when ROSE was diagnostic; when ROSE was non-diagnostic, transbronchial biopsy was performed using the robotic platform followed by conventional guided bronchoscopic approaches at the discretion of the investigator.

RESULTS: Fifty-five patients were enrolled at five centers. One patient withdrew consent, leaving 54 patients for data analysis. Median lesion size was 23mm (IQR 15mm to 29mm). R-EBUS was available in 53/54 cases. Lesion localization was successful in 51/53 (96.2%) patients. Pneumothorax was reported in 2/54 (3.7%) of cases, requiring tube thoracostomy in 1/54 (1.9 %) case. No additional adverse events occurred.

INTERPRETATION: This is the first, prospective, multicenter study of robotic bronchoscopy in patients with peripheral pulmonary lesions. Successful lesion localization was achieved in 96.2% of cases with an adverse event rate comparable to conventional bronchoscopic procedures. Additional large prospective studies are warranted to evaluate procedure characteristics such as diagnostic yield.

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ePub ahead of print