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A6153 - First in Human Use of a Hybrid Real-Time Ultrasound-Guided Fine Needle Acquisition System for Peripheral Pulmonary Lesions: A Multicenter Pilot Study
Author Block: L. B. Yarmus1, G. A. Silvestri2, N. J. Pastis3, A. C. Chen4; 1John Hopkins University, Baltimore, MD, United States, 2Med Univ of S Carolina, Charleston, SC, United States, 3Division of Pulmonary/Critical Care, Med Univ of S Carolina, Charleston, SC, United States, 4Washington Univ School of Med, Saint Louis, MO, United States.
Introduction: With the results of the National Lung Cancer Screening Trial demonstrating a reduction in lung cancer mortality, the number of nodules requiring diagnostic sampling is expected to increase. The diagnostic yield of pulmonary lesions with bronchoscopy varies widely due to anatomic and technological limitations. One of the major limitations in bronchoscopy is lack of the ability for bronchoscopists to utilize real time guidance during tissue sampling in the peripheral airways. A novel system has been developed which enables real-time visualization and sampling of peripheral pulmonary lesions by displaying an ultrasound image of the lesion and needle simultaneously. Methods We performed a multicenter prospective clinical trial in patients with peripheral pulmonary lesions (1 cm to 7 cm) with the intention to undergo a clinically indicated bronchoscopy under routine clinical care. The purpose of this study was to demonstrate feasibility to visualize, access, and obtain specimens adequate for cytology of lung lesions in subjects with suspected lung cancer when using a novel hybrid real-time ultrasound-guided fine needle aspiration system for peripheral pulmonary lesions. The primary endpoint was defined as the system’s ability to access peripheral lesions and acquire adequate specimens suitable for the cytologic evaluation under real-time visualization. Results Twenty-four peripheral pulmonary lesions were accessed in 23 patients. Mean lesion size was 3.6cm (range 1.7-5.7cm). Targeted lesions were located in all lobes of the lung, with the majority (47.8%) located in the right upper lobe. 24/24 (100%) lesions were successfully accessed using the ultrasound guided needle catheter. Real-time needle visualization within the ultrasound field was observed in 24/24 (100%) lesions. All specimens collected from 24 lesions were adequate for cytological evaluation. Conclusions: Current limitations to ultrasound guided peripheral lesion sampling include the lack of real time sampling guidance. In this feasibility study, we report the first in human use of a continuous real time ultrasound guidance system. The device was successfully advanced into all lobes of the lung and provided continuous real-time ultrasound visualization of the needle during specimen collection. Future studies are needed to determine the impact of continuous, real-time ultrasound guidance during specimen collection on the diagnostic yield of peripheral bronchoscopy procedures.