Development of new endoscopic irreversible electroporation ablation device: Animal experimental study.

Abstract

188 Background: Irreversible electroporation (IRE) is a promising novel technique for the ablation of tumors. An advantage of IRE is its mechanism to remove undesired cells by affecting the cell membrane without thermally destructing blood vessels, nerves and the surrounding tissues. Several clinical trials for applying IRE to human organs such as liver, pancreas, and kidney are conducted and studies about IRE ablation for gastrointestinal tumors also have been conducted recently. Here, we developed new endoscopic IRE device, and studied about its effectiveness and feasibility in animal model. Methods: Newly developed endoscopic IRE ablative catheter works with single channel of endoscope. A pair of dipolar electrodes consist of pre-shaped f 0.63mm nitinol wire and the distance between each electrode is 10 mm. The electrodes are loaded within braided tube for stent delivery system then deployed when IRE catheter put in stomach through the endoscope. We performed endoscopy and IRE ablation was done on pig’s stomach mucosa by using endoscopy with newly developed IRE catheter. We divided pig’s stomach into 2 parts(antrum & body), and IRE ablation was applied on each part of the stomach. Pigs were sacrificed after 24hours, and we collected their stomachs with surgical technique. Following fixation, tissues were stained with H&E. Results: Ten male Yorkshire pigs and in vitro stomachs were used in this study. The tissue with H&E stain showed diffuse cell death 24hr after IRE ablation. Consistent with the mechanism of action of IRE on the cell membrane only, there was complete cell death within the IRE lesions without intervening live cells. But there was no difference in histology depending on gastric part in which ablation was applied. During the study, no complication was observed in pigs in 24 hours after ablation. Conclusions: The new endoscopic IRE device, which can perform IRE ablation on gastrointestinal tract using endoscopy showed safe and feasible result.