First-in-Human Use of a Hybrid Real-Time Ultrasound-Guided Fine-Needle Acquisition System for Peripheral Pulmonary Lesions: A Multicenter Pilot Study.
BACKGROUND
The ability to successfully perform a biopsy on pulmonary lesions by means of bronchoscopy varies widely due to anatomic and technological limitations. One major limitation is the lack of the ability to utilize real-time guidance during tissue sampling in the periphery. A novel system has been developed that enables real-time visualization and sampling of peripheral lesions by displaying an ultrasound image of the lesion and needle simultaneously.


METHODS
We performed a multicenter, prospective pilot in patients with peripheral pulmonary lesions undergoing a clinically indicated bronchoscopy. The purpose of this study was to demonstrate the feasibility of visualizing, accessing, and obtaining specimens adequate for the cytology of lung lesions when using a novel hybrid real-time ultrasound-guided fine-needle aspiration system for peripheral pulmonary lesions.


RESULTS
Twenty-three patients underwent bronchoscopic sampling of a peripheral pulmonary lesion with the study device. Mean lesion size was 3.6 (range 1.7-5.7) cm. Targeted lesions were located in all lobes of the lung. All lesions were successfully visualized and sampled under real-time visualization with specimens adequate for cytological evaluation. The needle was visualized in all lesions throughout targeting and sampling. There were no incidents of pneumothorax or moderate-to-severe bleeding.


CONCLUSION
In this feasibility study, we report the first-in-human use of a continuous real-time endobronchial ultrasound guidance system to sample peripheral pulmonary lesions. Future generations of this device may improve usability and further studies are needed to determine the true diagnostic capabilities of this novel technique.
['Yarmus|Lonny B|LB|', 'Mallow|Christopher|C|', 'Pastis|Nicholas|N|', 'Thiboutot|Jeffrey|J|', 'Lee|Hans|H|', 'Feller-Kopman|David|D|', 'Lerner|Andrew D|AD|', 'Tanner|Nicole|N|', 'Silvestri|Gerard|G|', 'Chen|Alexander|A|', '|||']
D000046:Academic Medical Centers D000230:Adenocarcinoma D000368:Aged D015142:Baltimore D001999:Bronchoscopy D002289:Carcinoma, Non-Small-Cell Lung D002294:Carcinoma, Squamous Cell D061765:Endoscopic Ultrasound-Guided Fine Needle Aspiration D005260:Female D006801:Humans D007150:Immunohistochemistry D008175:Lung Neoplasms D008297:Male D008875:Middle Aged D009361:Neoplasm Invasiveness D009367:Neoplasm Staging D010865:Pilot Projects D011013:Pneumonectomy D011446:Prospective Studies D012680:Sensitivity and Specificity D013048:Specimen Handling D016019:Survival Analysis
Peripheral pulmonary lesions Bronchoscopy Ultrasound-guided fine-needle aspiration