Dataset Information

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.

SUBMITTER: de Baere T

PROVIDER: S-EPMC9626422 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Publications

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

de Baère Thierry T Roux Charles C Deschamps Frédéric F Tselikas Lambros L Guiu Boris B

Cardiovascular and interventional radiology 20220920 11

<h4>Purpose</h4>To assess the feasibility and safety of a robotic system for percutaneous needle insertion during thermal ablation of liver tumors.<h4>Materials and methods</h4>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 ...[more]

PMID: 36127519

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Project description:BackgroundPercutaneous ablation is an alternative treatment for lung cancer in non-operable patients. This is a prospective clinical trial for percutaneous microwave ablation (pMWA) of biopsy-proven lung cancer to demonstrate safety and efficacy.MethodsA prospective trial from 6-1-2016 to 1-1-2019 enrolled patients with biopsy-proven primary or metastatic lung cancer <3 cm in size and 1 cm away from the pleura for pMWA with the Emprint Ablation System with Thermosphere Technology for Phase I analysis, (Clinicaltrials.gov; #NCT0267302). Patients were followed for 1 year with PET/CT and PET/MR to determine patterns of recurrence and efficacy of ablation.ResultsAfter 12 patients consented for biopsy, 6 patients underwent treatment of 7 lesions, 3/6 women, median age of 67 (IQR, 65-70) years, body mass index (BMI): 27.8 (IQR, 21.4-32.1) kg/m2, lesion distance to pleura 24.4 (IQR, 13-38) mm, lesion size of 10.7 (IQR, 6-14) mm, and ablation duration time 5.9 (IQR, 3-10) minutes. pMWA were completed at 75 W. Twelve adverse events were reported (1 Grade 3, 3 Grade 2, and 8 Grade 1 events) with Grade 4 or 5 events. Mean % change after ablation in forced expiratory volume in one second (FEV1) was -2% and diffusion capacity for carbon monoxide (DLCO) was -1%. After 2-3 months, the lesions would decrease in size, rim thickness, fluorodeoxyglucose (FDG) activity, and T2 signal. FDG activity after 6 months was below blood pool in all cases. The ablation zones stabilized by 6-12 months. One patient expired during the study from pneumonia unrelated to ablation without local recurrence. Of the seven ablations during the 1 year follow-up, there was local tumor recurrence at 271 days following ablation at the apex of the ablation zone, subsequently successfully treated with percutaneous cryoablation (Cryo).ConclusionspMWA appears to be a safe and effective mechanism for treatment of primary and secondary tumors of the lung, with possible preservation of pulmonary function.

Project description:ObjectivesTo evaluate the accuracy of robotic CT-guided out-of-plane needle insertion in phantom and animal experiments.MethodsA robotic system (Zerobot), developed at our institution, was used for needle insertion. In the phantom experiment, 12 robotic needle insertions into a phantom at various angles in the XY and YZ planes were performed, and the same insertions were manually performed freehand, as well as guided by a smartphone application (SmartPuncture). Angle errors were compared between the robotic and smartphone-guided manual insertions using Student's t test. In the animal experiment, 6 robotic out-of-plane needle insertions toward targets of 1.0 mm in diameter placed in the kidneys and hip muscles of swine were performed, each with and without adjustment of needle orientation based on reconstructed CT images during insertion. Distance accuracy was calculated as the distance between the needle tip and the target center.ResultsIn the phantom experiment, the mean angle errors of the robotic, freehand manual, and smartphone-guided manual insertions were 0.4°, 7.0°, and 3.7° in the XY plane and 0.6°, 6.3°, and 0.6° in the YZ plane, respectively. Robotic insertions in the XY plane were significantly (p < 0.001) more accurate than smartphone-guided insertions. In the animal experiment, the overall mean distance accuracy of robotic insertions with and without adjustment of needle orientation was 2.5 mm and 5.0 mm, respectively.ConclusionRobotic CT-guided out-of-plane needle insertions were more accurate than smartphone-guided manual insertions in the phantom and were also accurate in the in vivo procedure, particularly with adjustment during insertion.Key points• Out-of-plane needle insertions performed using our robot were more accurate than smartphone-guided manual insertions in the phantom experiment and were also accurate in the in vivo procedure. • In the phantom experiment, the mean angle errors of the robotic and smartphone-guided manual out-of-plane needle insertions were 0.4° and 3.7° in the XY plane (p < 0.001) and 0.6° and 0.6° in the YZ plane (p = 0.65), respectively. • In the animal experiment, the overall mean distance accuracies of the robotic out-of-plane needle insertions with and without adjustments of needle orientation during insertion were 2.5 mm and 5.0 mm, respectively.

Dataset Information

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

Purpose

Materials and methods

Results

Conclusion

Publications

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

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