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. 2022 Nov;45(11):1701-1709.
doi: 10.1007/s00270-022-03267-z. Epub 2022 Sep 20.

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

Thierry de Baère  1 , Charles Roux  2 , Frédéric Deschamps  2 , Lambros Tselikas  2 , Boris Guiu  3
Affiliations

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

Thierry de Baère et al. Cardiovasc Intervent Radiol. 2022 Nov.

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.

Keywords: Computed tomography; Liver cancer; Needle navigation; Robotic navigation; Thermal ablation.

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Conflict of interest statement

The authors of this manuscript declare relationships with the following companies: Thierry de Baère is consultant for and receive research grant from Quantum Surgical, consultant and speaker for Boston Scientific, GE Healthcare, AstraZeneca and Boris Guiu is consultant for Quantum Surgical, Boston Scientific, Canon Medical, Roche, Ipsen, Terumo and received research grant from his work.

Figures

Figure 1
Figure 1
Patient flowchart
Figure 2
Figure 2
components of the robotic device. The device is composed of a mobile robot (A), navigation cart (B) and display cart (C). Needle guide (D) is attached to the robot arm and provides mechanical guidance for rigid straight needles. Patient reference (E) is adhesively attached on to the patient’s skin and enables to monitor respiratory motion.
Figure 3
Figure 3
Respiratory monitoring module displayed on the display cart. The orange line is showing the live respiratory movement. When an apnea is performed, the curve stabilizes, and a reference level can be defined (blue line). A gating threshold is also displayed as a green gating band to help verifying apnea or breath-hold repeatability.
Figure 4
Figure 4
Example of robot-guided needle placement for thermal ablation (A). Planning definition on CT-scan image of needle trajectory (in yellow) to treat a lesion of segment IVa (segmented in red). The simulation of the ablation zone (in blue) is positioned to entirely cover the lesion and safety margins. (B) Robotic guidance: robot automatic positioning to align needle guide on planned trajectory and needle insertion in single-pass through needle guide until the mechanical stop. (C) Needle placement control: after insertion, the needle placement is compared with the planned trajectory and the ablation is performed if the needle placement is satisfying.
Figure 5
Figure 5
Challenging liver tumors localization.
See this image and copyright information in PMC

References

    1. Li P, Kang J, Madoff DC. Locally ablative therapies for primary and metastatic liver cancer. Expert Rev Anticancer Therapy. 2014;14(8):931–45. doi: 10.1586/14737140.2014.911091. - DOI - PubMed
    1. Reig M, Forner A, Rimola J, Ferrer-Fàbrega J, Burrel M, Garcia-Criado Á, et al. BCLC strategy for prognosis prediction and treatment recommendation: the 2022 update. J Hepatol. 2022;76(3):681–693. doi: 10.1016/j.jhep.2021.11.018. - DOI - PMC - PubMed
    1. Beyer LP, Pregler B, Nießen C, Schicho A, Haimerl M, Jung EM, et al. Stereotactically-navigated percutaneous Irreversible Electroporation (IRE) compared to conventional IRE: a prospective trial. PeerJ. 2016;4:e2277. doi: 10.7717/peerj.2277. - DOI - PMC - PubMed
    1. Crocetti L, de Baére T, Pereira PL, Tarantino FP. CIRSE standards of practice on thermal ablation of liver tumours. CardioVasc Intervent Radiol. 2020;43:951–62. doi: 10.1007/s00270-020-02471-z. - DOI - PubMed
    1. Bale R, Putzer D, Schullian P. Local treatment of breast cancer liver metastasis. Cancers. 2019;11(9):1341. doi: 10.3390/cancers11091341. - DOI - PMC - PubMed

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