The Robotic Navigational System In Preoperative CT-Guided Percutaneous Lung Nodules Localization

BackgroundThe effectiveness of preoperative percutaneous localization of pulmonary nodules under CT-guidance is well established,but traditional manual localization still lacks accuracy.Therefore,a new generation of robot-assisted navigation systems has been developed for the accurate localization of pulmonary nodules.The purpose of the study was to investigate the accuracy and safety of the robot-assisted navigation system in CT-guided percutaneous pulmonary nodule localization.MethodsThis study is divided into two parts: animal experiment and clinical trial.A total of four male Bama minipigs were included in the in vivo animal experiment for the intervention.The pigs were intravenously anesthetized and under tracheal intubation,followed by CT-guided injection of medical sealant into the lungs to simulate pulmonary nodules,and then the CT-guided percutaneous localization of pulmonary nodules was conducted using a robot-assisted navigation system.Moreover,in the randomized clinical trial,a total of 66 patients with peripheral solitary pulmonary nodules(size < 2 cm)with indications for preoperative localization were recruited,with 33 patients in the robotic group and 33 in the conventional manual group.The robotic group registered the patient’s CT images into a robotic navigation system to calculate and simulate the desired localization path,which was finally further inserted manually by the surgeon.The manual group was also localized by CT-guided injection of indocyanine green.The primary outcome of both the animal experiment and clinical trial was the accuracy under three-dimensional spatial measurements.The secondary outcomes of the clinical trial were the complication rate,time cost and radiation exposure.ResultsIn the animal experiment,a total of 20 simulated lung nodules were implanted and all were successfully localized.The mean deviation by three-dimensional measurements was 3.81±1.29 mm.In the randomized clinical trial,a total of 33 patients received robotic localization and 33 received conventional manual method.The mean accuracy in the robotic and manual groups was 5.57±3.50 mm and17.26±7.47 mm,respectively(p<0.001).No patients in the robotic group had surgical related complications,whereas 13 patients in the manual group had postoperative complications(p<0.001).However,the overall duration of operation was significantly longer in the robotic group than in the manual group(24.91±7.68 min vs.16.12±3.15 min,p<0.001),and the robot group received significantly more radiation exposure(1440.09±306.08 m As vs.1105±506.91 m As,p=0.001)and dose-length product(DLP)(519.85±150.12 m As* cm vs.316.16 ± 192.45 m As* cm,p<0.001)than the manual group.ConclusionWe found that the robotic-assisted navigation system achieved high accuracy in preoperative CT-guided percutaneous lung nodule localization in animal studies.In the randomized clinical trial,the robotic navigation system maintained the same high accuracy and had fewer complications when compared with conventional manual localization.But it is needed to optimize the operational procedures to lay the foundation for the further clinical application.