Yano Tomonori, Ono Hiroyuki, Doi Toshihiko, Hasegawa Hiromi, Honda Minako, Oono Yasuhiro, Ikematsu Hiroaki, Tanaka Masaki, Kakushima Naomi, Kaneko Kazuhiro, Sato Akihiro, Ohtsu Atsushi
Department of Gastroenterology, Endoscopy Division, National Cancer Center Hospital East, Kashiwa, Japan.
Endoscopy Division, Shizuoka Cancer Center, Shizuoka, Japan.
Endoscopy. 2014 Sep;46(9):754-7. doi: 10.1055/s-0034-1365473. Epub 2014 Apr 25.
Endoscopic submucosal dissection (ESD) is more difficult and has a higher rate of complications, such as perforation and bleeding, compared with conventional endoscopic resection. The aim of this study was to evaluate the feasibility of a new scissors-type electrosurgical knife for ESD, which was developed for improved durability and ease of use.
Initial ex vivo experiments and subsequent ESD procedures in live pigs were carried out. A human feasibility study was then performed in patients with early esophageal or gastric cancer. The primary end point was serious adverse events (SAE) related to ESD.
In the ex vivo and live animal models, no mechanical errors occurred and only minor damage to surrounding tissue was observed. Four patients were enrolled in the human feasibility study; all ESD procedures were completed with a mean procedure time of 31 minutes. All specimens were resected completely without any SAEs. The device worked smoothly, with no electrical problems noted.
ESD using a novel scissors-type knife for early esophageal or gastric cancer is feasible.
UMIN000004941.
与传统内镜切除术相比，内镜黏膜下剥离术（ESD）操作难度更大，并发症发生率更高，如穿孔和出血。本研究旨在评估一种新型剪刀式电刀用于ESD的可行性，该电刀专为提高耐用性和易用性而研发。
首先进行离体实验，随后在活猪身上进行ESD手术。接着对早期食管癌或胃癌患者开展人体可行性研究。主要终点是与ESD相关的严重不良事件（SAE）。
在离体和活体动物模型中，未发生机械故障，仅观察到对周围组织的轻微损伤。四名患者纳入人体可行性研究；所有ESD手术均顺利完成，平均手术时间为31分钟。所有标本均完整切除，未出现任何严重不良事件。该设备运行顺畅，未发现电气问题。
使用新型剪刀式刀对早期食管癌或胃癌进行ESD是可行的。
UMIN000004941。
