Safety analysis of endoscopic haemostasis using a high-frequency live tissue electric welding device - EKVZ300 PATONMED.
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The method of a bipolar high-frequency welding (HFEW) of soft living tissues of animals and humans has been used in various areas of surgery. However, it has not been utilized in endoscopic gastrointestinal procedures yet. HFEW has strong potential to be used in gastrointestinal endoscopic procedures due to the competitive cost of generator devices and due to its proven ability to coagulate vessels of wide diameter as compared to standard electrocautery devices.To investigate the effectiveness of the endoscopic haemostasis using HFEW generator device - 300 PATONMED - in a porcine model of arterial gastrointestinal bleeding.A porcine model of arterial gastrointestinal bleeding was created. A 300 PATONMED set to the "welding" regime and a flexible 7 Fr bipolar coagulation probe with two electrodes on the tip fashioned spirally attached to convey energy were tested. Once bleeding from the artery had been initiated, the bipolar probe was applied to coagulate the bleeding site. Animals were observed for clinical evidence of recurrent bleeding and subsequently were euthanised for histological examination.A total of 10 experiments were successfully completed. An optimal haemostatic effect was achieved with durations of cautery of five to eight seconds in all animals. Continuous observation after haemostasis revealed no evidence of re-bleeding. No systemic side-effects of the technique were observed. Histological examination has shown that the peripheral thermal injury area that surrounded the coagulation zone did not spread beyond the mucosal layer in depth and 2 mm in width.This animal study provided evidence for the safety of an HFEW in the treatment of gastrointestinal bleeding. The advantages of this technology are smokeless operative area, no tissue overheating, minimal necrosis and damage to surrounding gastric tissue, and the fact that the area of HFEW is confined to the area of the electrodes.