Accuracy of a Robotic Endoscopic System in Cadaver Models with Simulated Tumor Targets: ACCESS Study

Abstract

<b><i>Background:</i></b> Bronchoscopy for the diagnosis of peripheral pulmonary lesions continues to present clinical challenges, despite increasing experience using newer guided techniques. Robotic bronchoscopic platforms have been developed to potentially improve diagnostic yields. Previous studies in cadaver models have demonstrated increased reach into the lung periphery using robotic systems compared to similarly sized conventional bronchoscopes, although the clinical impact of additional reach is unclear. <b><i>Objectives:</i></b> This study was performed to evaluate the performance of a robotic bronchoscopic system’s ability to reach and access artificial tumor targets simulating peripheral nodules in human cadaveric lungs. <b><i>Methods:</i></b> Artificial tumor targets sized 10–30 mm in axial diameter were implanted into 8 human cadavers. CT scans were performed prior to procedures and all cadavers were intubated and mechanically ventilated. Electromagnetic navigation, radial probe endobronchial ultrasound, and fluoroscopy were used for all procedures. Robotic-assisted bronchoscopy was performed on each cadaver by an individual bronchoscopist to localize and biopsy peripheral lesions. <b><i>Results:</i></b> Sixty-seven nodules were evaluated in 8 cadavers. The mean nodule size was 20.4 mm. The overall diagnostic yield was 65/67 (97%) and there was no statistical difference in diagnostic yield for lesions <20 mm compared with lesions measuring 21–30 mm, the presence of a concentric or eccentric radial ultrasound image, or relative distance from the pleura. <b><i>Conclusions:</i></b> The robotic bronchoscopic system was successful at biopsying 97% of peripheral pulmonary lesions 10–30 mm in size in human cadavers. These findings support further exploration of this technology in prospective clinical trials in live human subjects.

Robotic Bronchoscopy for Peripheral Pulmonary Lesions

“…Second, the observed adverse event rate of procedures was low, even among novice operators who previously had not used the new technology outside of cadaver models. 6 , 7 This may be of significance in that, unlike conventional bronchoscopy, robotic systems do not provide the operator with haptic feedback. Although prior cadaver studies had assessed the ability to navigate peripheral airways, safety data could not be evaluated readily.…”

“…6 Additional preclinical studies demonstrated high accuracy with the use of the robotic system to perform transbronchial needle aspiration (TBNA) of simulated tumor targets sized 1 to 3 cm in cadaveric lungs and the ability to place biopsy instruments within targeted lesions in cadaver models with a greater degree of accuracy compared with conventional guided approaches. 7,8 Presently, very few data exist regarding the use of a robotic endoscopic system in live human subjects with peripheral lesions in need of biopsy. 9,10 This study was performed to assess the feasibility of performing robotic bronchoscopy to locate peripheral lesions in patients and to evaluate the safety and performance characteristics of procedures in a multicenter, prospective trial.…”

Bronchoscopic treatment of inoperable nonsmall cell lung cancer

“…The newest iteration of image-guided bronchoscopy is robotic bronchoscopy, where platforms that combine advanced imaging guidance techniques with automated scopes capable of reaching the periphery of the lungs are used to access lesions previously deemed out of reach of conventional bronchoscopic techniques [91]. Initial feasibility studies are promising, even when compared to advanced techniques such as EMN bronchoscopy [91][92][93][94]. Robotic and EMN bronchoscopy have traditionally been employed as diagnostic modalities, but great interest exists in leveraging these technologies to apply therapeutic modalities for patients with peripheral nodules who cannot undergo surgical resection.…”

Robotic Bronchoscopy for the Diagnosis of Peripheral Lung Nodules: a Review

“…The ACCESS study [2] was performed in human cadaveric lungs using the Monarch™ platform. Operators included 8 bronchoscopists, 8 cadavers, and artificial tumor targets that were implanted 0-33 mm from the pleura.…”

“…An estimated 1.6 million new pulmonary nodules will be detected by chest CT scans annually in the USA [2]. Most detected nodules are benign and it is often difficult to radiographically distinguish those that are malignant, leading to the need for biopsies.…”