Evaluation of a New CT-Guided Robotic System for Percutaneous Needle Insertion for Thermal Ablation of Liver Tumors: A Prospective Pilot Study

Abstract

Purpose To assess the feasibility and safety of a robotic system for percutaneous needle insertion during thermal ablation of liver tumors. Materials and Methods This study analyzed the CT-guided percutaneous needle insertion using the EPIONE robotic device (Quantum Surgical, Montpellier, France) for radiofrequency or microwave liver ablation. The main criteria of the study were feasibility (possibility to perform the thermal ablation after needle insertion), the number of needle adjustments (reiteration of robotically assisted needle insertion when initial needle positioning is considered insufficient to perform ablation), and robotic-guided procedure safety (complications related to the needle insertion). Patients were followed up at 6 months post-intervention to assess local tumor control. Results Twenty-one patients with 24 tumors, including 6 HCC and 18 metastases measuring 15.6 ± 7.2 mm, were enrolled. One patient (with one tumor) was excluded for protocol deviation. Robotic assisted thermal ablation was feasible for 22/23 lesions (95.7%) and 19/20 patients (95.0%), as validated by a data safety monitoring Board (95% CI [76.39%; 99.11%]) for the per-protocol population. The mean number of needle adjustments per tumor treated was 0.4 (SD: 0.7), with 70.8% of tumors requiring no adjustment. No adverse events were depicted. Rate of local tumor control was 83.3% for patients and 85.7% for tumors, at 6 months. Conclusion This bicentric first-in-human pilot study suggests both feasibility and safety of a stereotactic CT-guided EPIONE device for the percutaneous needle insertion during liver tumor thermal ablation.

Thermal ablation of hepatocellular carcinoma

“…On average, each lesion required only 0.4 needle adjustments (±0.7), with only 29.2% of the lesions necessitating needle adjustment 37 . Feasibility was not compromised in case of lesions requiring substantial angulation and out‐of‐plane trajectories 37 . Complex targeting trajectories, including intercostal trajectories and steep trajectory angles, do not have any significant impact on the accuracy of targeting, as demonstrated in a study conducted by Tinguely et al 38 .…”

“…On average, each lesion required only 0.4 needle adjustments (AE0.7), with only 29.2% of the lesions necessitating needle adjustment. 37 Feasibility was not compromised in case of lesions requiring substantial angulation and out-of-plane trajectories. 37 Complex targeting trajectories, including intercostal trajectories and steep trajectory angles, do not have any significant impact on the accuracy of targeting, as demonstrated in a study conducted by Tinguely et al 38 In their experience, Lachenmayer et al 39 reported low average lateral and longitudinal errors (3.2 mm and 1.6 mm, respectively) without requiring supplementary techniques, like hydrodissection, to address anatomical difficulties and facilitate the placement of the ablation probe.…”

“…The feasibility rate of the robotic needle placement was determined to be 95.7%. On average, each lesion required only 0.4 needle adjustments (±0.7), with only 29.2% of the lesions necessitating needle adjustment 37 . Feasibility was not compromised in case of lesions requiring substantial angulation and out‐of‐plane trajectories 37 .…”

Current State of Robotics in Interventional Radiology

“…The EPIONE robotic system (Quantum Surgical, Montpellier, France), both CE marked, and FDA cleared, is another robotic system used in CT-guided percutaneous needle insertion. The EPIONE robotic system has 6 DOF and is comprised of five components: the mobile arm (1) which has attached to it the needle guide (2), an infra-red camera (3) acting as the navigation cart, a workstation (4), and patient reference (5) which is adhesively attached to the patient’s skin and allows tracking of patient’s respiratory cycle [ 60 ]. This robotic system has been safely used in CT-guided percutaneous needle placement for targeting of previously implanted fiducials in the liver of ten swine [ 61 ].…”

“…All needle insertions successfully reached the target on the first attempt with no need for readjustment; however, there were two subcapsular haematomas which did not progress to retroperitoneal effusions [ 62 ]. In a recent prospective study, the EPIONE robotic system was used for robotic-assisted thermal ablation of liver tumours [ 60 ].…”