Robotic-assisted Optical Navigation System for CT-guided Preoperative Percutaneous Hook-wire Localization of Pulmonary Nodules: a Prospective, Single-center, Single-arm Clinical Study

Background Robotic-assisted navigation systems for the localization of nonvisible and nonpalpable pulmonary nodules have demonstrated feasibility and safety in preclinical animal studies; however, clinical evidence supporting their practical application remains limited. This study aims to evaluate the safety and feasibility of using a robotic-assisted system for computed tomography (CT)-guided percutaneous localization of lung nodules. Methods A total of 137 consecutive patients with 155 nodules were included in the final analysis, all of whom underwent percutaneous hook-wire localization using a novel robotic-assisted optical navigation system. The baseline characteristics of patients and nodules, localization procedure findings, and exploratory outcomes of the correlations between pulmonary nodule features and localization procedure findings were analyzed. Results The localization success rate was 100%. With the assistance of the robotic-assisted optical navigation system, the median number of needle adjustments per target was 0 (ranging from 0 to 2) in this study, with a mean deviation of 1.49 ± 1.93 mm. The mean intervention time was 8.24 ± 1.77 minutes during the robotic-assisted process. Notably, there was no significant change in the accuracy influenced by the location, type, size of nodules, distance to pleura, and decubitus positions. Localization-related complications occurred in 13 (8.39%) out of 155 targets, including 3 (1.94%) minor hemorrhages and 10 (6.45%) minor pneumothoraxes, and no dislodgement was observed in any of the cases. All surgeries were successfully performed with a mean time interval between nodule localization and surgery of 133.67 ± 103.36 minutes. Conclusions This prospective, single-center, single-arm clinical study suggests both feasibility and safety of an innovative robotic-assisted optical navigation system for the CT-guided percutaneous localization of pulmonary nodules using hook-wire technique, as well as satisfactory accuracy during the needle placement.