Abstract
The aim of the study is to evaluate the usability aspects of new deployable, expandable, electrode prototypes, in terms of suitability solutions for laparoscopic applications on the liver, endoscopic trans-oral and trans-anal procedures, electroporation segmentation in several steps, mechanical functionality (flexibility, penetrability), visibility of the electrode under instrumental guidance, compatibility of the electrode with laparoscopic/endoscopic accesses, surgical instruments, and procedural room and safety compatibility. The electroporation was performed on an animal model (Sus Scrofa Large White 60 kg) both in laparoscopy and endoscopy, under ultrasound guidance, and in open surgery. Electrodes without divergence, with needles coming out straight, parallel to each other, and electrodes with peripheral needles (four needles), diverging from the electrode shaft axis (electrode with non-zero divergence) have been tested. To cause an evaluable necrosis effect, the number of electrical pulses was increased to induce immediate liver cell death. Histological samples were analyzed by staining with Haematoxylin/Eosin or by immunohistochemical staining to confirm complete necrosis. The prototypes of expandable electrodes, tested in laparoscopy and endoscopy and in open surgery, respectively, are suitable in terms of usability, electroporation segmentation in several steps, mechanical functionality (flexibility, penetrability), visibility under instrumental guidance, compatibility with laparoscopic/endoscopic accesses, surgical instruments and procedural room safety, patient safety (no bleeding and/or perforation), and treatment efficacy (adequate ablated volume). Electroporation treatment using new deployable expandable electrode prototypes is safe and feasible. Moreover, electrode configurations allow for a gradual increase in the ablated area in consecutive steps, as confirmed by histology and immunohistochemistry.
Highlights
The clinical use of electroporation (EP) techniques has spread in the last 10 years in Europe and the USA
One irreversible EP treatment for each electrode configuration was performed on the liver using both laparoscopic approach and open surgery
The treatment result was evaluated in terms of the presence of necrosis
Summary
The clinical use of electroporation (EP) techniques has spread in the last 10 years in Europe and the USA. For irreversible electroporation, it was reported that the increase of pulse application could determine both an efficacy increase of the treatment and associated thermal damage [5,6], limited to the area around the electrodes [5,6,9] This effect is minimized in cases of reversible electroporation, considering an electric protocol, according to European Standard Operating Procedures of Electrochemotherapy (ESOPE) [10,11,12], which consists of 8 pulses of 100 μs, divided into two groups of four, with inversion of the applied voltage, and an electric field of 1000 V/cm
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