Feasibility, Safety and Accuracy of a Novel Robotic Navigation System for Cone-Beam CT-guided and TACE-assisted Radiofrequency Ablation of Hepatocellular Carcinoma, a Preliminary Study

Abstract Purpose To evaluate the technical feasibility, targeting accuracy and short-term safety of a novel integrated system of the robot-navigated, cone-beam CT (CBCT)-guided and transarterial chemoembolization (TACE)-assisted radiofrequency ablation (RFA) for hepatocellular carcinoma (HCC) in high-risk locations. Materials and methods This retrospective, single-center study enrolled 11 participants with HCC lesions in high-risk locations. All participants underwent TACE followed by RFA navigated by a novel robotic system. Trajectory planning was based on respiratory-gated CBCT images and the subsequent needle insertion was guided by real-time fluoroscopy. The evaluated outcomes included the first placement accuracy, the adequate placement accuracy, targeting time, repositioning times, radiation exposure dose, complications and the 1-month complete ablation rate. Results The cohort included 10 males and 1 female. Technical success was achieved in 100% (11/11) of cases. The median tumor diameter was 16.20 mm and the mean tumor depth was 79.37 mm. Seven tumors were located in the subdiaphragmatic position, three tumors were situated adjacent to major vascular structures and one tumor was located adjacent to extrahepatic organs. The median Euclidean error and angle error of the first placement were 6.2 mm and 3.0 degrees, respectively. The median Euclidean error and angle error of the adequate placement was 2.2 mm and 1.3 degrees. The median targeting time was 6.70 min (range, 1.55–29.52 min) and the median number of repositioning adjustments was 2. The mean cumulative air kerma was 216.34 mGy. The 1-month complete ablation rate was 81.8% (9/11) following adjunctive ablation in 2 patients. No major complications were reported. Conclusion The integrated platform of robotic-navigated, real-time CBCT-guided, and TACE-assisted RFA is technically feasible and demonstrates short-term safety. In this cohort, it achieves preliminary targeting accuracy for the ablation of HCC in high-risk locations.