Endoscopic submucosal dissection using a new scissors-type electrosurgical knife: a first-in-human feasibility study.
OBJECTIVE
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
ESD using a novel scissors-type knife for early esophageal or gastric cancer is feasible.


BACKGROUND
UMIN000004941.
Department of Gastroenterology, Endoscopy Division, National Cancer Center Hospital East, Kashiwa, Japan.
Tomonori
T
Yano
Endoscopy Division, Shizuoka Cancer Center, Shizuoka, Japan.
Hiroyuki
H
Ono
Department of Gastroenterology, Gastrointestinal Oncology Division, National Cancer Center Hospital East, Kashiwa, Japan.
Toshihiko
T
Doi
Clinical Trial Section, Research Center for Innovative Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Hiromi
H
Hasegawa
Clinical Trial Section, Research Center for Innovative Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Minako
M
Honda
Department of Gastroenterology, Endoscopy Division, National Cancer Center Hospital East, Kashiwa, Japan.
Yasuhiro
Y
Oono
Department of Gastroenterology, Endoscopy Division, National Cancer Center Hospital East, Kashiwa, Japan.
Hiroaki
H
Ikematsu
Endoscopy Division, Shizuoka Cancer Center, Shizuoka, Japan.
Masaki
M
Tanaka
Endoscopy Division, Shizuoka Cancer Center, Shizuoka, Japan.
Naomi
N
Kakushima
Department of Gastroenterology, Endoscopy Division, National Cancer Center Hospital East, Kashiwa, Japan.
Kazuhiro
K
Kaneko
Clinical Trial Section, Research Center for Innovative Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Akihiro
A
Sato
Department of Gastroenterology, Gastrointestinal Oncology Division, National Cancer Center Hospital East, Kashiwa, Japan.
Atsushi
A
Ohtsu
D000368:Aged; D000818:Animals; D003106:Colon / Q000601:surgery; D004210:Dissection / Q000009:adverse effects / Q000295:instrumentation*; D004598:Electrosurgery / Q000295:instrumentation*; D004938:Esophageal Neoplasms / Q000601:surgery*; D005240:Feasibility Studies; D005260:Female; D005753:Gastric Mucosa / Q000601:surgery; D006801:Humans; D007413:Intestinal Mucosa / Q000601:surgery; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D013274:Stomach Neoplasms / Q000601:surgery*; D013552:Swine