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- W3200549887 abstract "Presenter: Tyler Wanke | Northwestern University Background: Hepatic resection is the cornerstone of treatment for various primary and secondary liver tumors. Radiofrequency (RF) ablation can be used as bridge therapy for those awaiting transplant, those that are poor surgical candidates, and those with surface neoplasms. Additionally, RF ablation of the resected surface of the liver can provide hemostasis and extend the surgical margin to reduce the risk of local recurrence. Current hepatic ablation devices are needle-based and/or have small (< 6mm diameter) electrode tips. The SIRA™ device (Innoblative Designs, Inc., Chicago, IL) is a saline-coupled RF ablation device with a larger electrode probe (4cm diameter), allowing for controlled ablation (∼1cm depth) of larger surfaces, which the needle-based devices are unable to do. In this Good Laboratory Practice (GLP) study, we aimed to demonstrate the SIRA’s ability to produce accurate and reliable ablation zones during in vivo procedures, its ease of use, and its safety. Methods: Six transplant or oncology surgeons were trained on the device. The porcine liver was exposed through laparotomy, target circles were marked using an electrosurgical pencil, and each surgeon performed 4 liver surface ablations, for a total of 24 ablations across 6 animals. Half of the ablations were performed at low power (35W) and low duration (7min), and the other half were performed at high power (65W) and high duration (10min). The purpose of the target circles was to show the SIRA could provide precise and reliable ablations to a targeted area without collateral damage to nearby tissue. This was monitored by: grossly measuring the height/width at the surface of the ablation, analyzing any extension of the ablation past the circle, and having each surgeon complete a questionnaire ranking the usability and safety of the device. To measure the ablation depths, each site was excised and cross-sectioned, and the maximum depths were measured by a board-certified pathologist. Results: All users were able to fully ablate the targets without significant extension of the ablation past the target boundary (see Figure 1). At the low setting, the 12 procedures had a mean histological ablation depth of 0.98cm (SD=0.23cm). At the high setting, the 12 procedures had a mean histological ablation depth of 1.27cm (SD=0.17cm). The ease of using the device was ranked an average score of 5 out of 5 (very easy). No injuries occurred to any unintended anatomical structures. Conclusion: This GLP animal study shows the SIRA device’s ability to accurately and reliably ablate the surface of in vivo porcine liver tissue. The ablation height/width and depth measurements were consistent across multiple animals and multiple surgeons, and the device was safely used without causing any unintended damage to adjacent anatomical structures, despite the device’s larger size. These successful results show feasibility of the SIRA device to provide a controlled surface ablation over a larger area in a shorter amount of time than is typically provided by needle-based/smaller devices. It also shows SIRA’s feasibility to obtain a controlled ablation depth to treat surface neoplasms or aid in augmenting margins and providing hemostasis after resection." @default.
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- W3200549887 date "2021-01-01" @default.
- W3200549887 modified "2023-09-27" @default.
- W3200549887 title "Accuracy and reliability of a novel saline-coupled intraoperative radiofrequency ablation and coagulation device on in vivo porcine liver" @default.
- W3200549887 doi "https://doi.org/10.1016/j.hpb.2021.06.188" @default.
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