Combining Shape-Sensing Robotic Bronchoscopy With Mobile Three-Dimensional Imaging to Verify Tool-in-Lesion and Overcome Divergence: A Pilot Study

Objective: To determine whether CT-to-body divergence can be overcome to improve the diagnostic yield of peripheral pulmonary nodules with the combination of shape-sensing robotic-assisted bronchoscopy (SSRAB) and portable 3-dimensional (3D) imaging. Patients and Methods: A single-center, prospective, pilot study was conducted from February 9, 2021, to August 4, 2021, to evaluate the combined use of SSRAB and portable 3D imaging to visualize tool-in-lesion as a correlate to diagnostic yield. Results: Thirty lesions were subjected to biopsy in 17 men (56.7%) and 13 women (43.3%). The median lesion size was 17.5 mm (range, 10-30 mm), with the median airway generation of 7 and the median distance from pleura of 14.9 mm. Most lesions were in the upper lobes (18, 60.0%). Tool-in-lesion was visualized at the time of the procedure in 29 lesions (96.7%). On the basis of histopathologic review, 22 (73.3%) nodules were malignant and 6 (20.0%) were benign. Two (6.7%) specimens were suggestive of inflammation, and the patients elected observation. The mean number of spins was 2.5 (±1.6) with a mean fluoroscopy time of 8.7 min and a mean dose area product of 50.3 Gy cm2 (±32.0 Gy cm2). There were no episodes of bleeding or pneumothorax. The diagnostic yield was 93.3%. Conclusion: This pilot study shows that the combination of mobile 3D imaging and SSRAB of pulmonary nodules appears to be safe and feasible. In conjunction with appropriate anesthetic pathways, nodule motion and divergence can be overcome in most patients. Trial Registration: https://clinicaltrials.gov Identifier NCT04740047