Efficacy of an endo-knife with a water-jet function (Flushknife) for endoscopic submucosal dissection of superficial colorectal neoplasms.
OBJECTIVE
Endoscopic submucosal dissection (ESD) is currently not a common treatment for colorectal neoplasms because it is time consuming and technically difficult. Flushknife--an electrosurgical endo-knife with a water-jet function--is expected to reduce the difficulty of colorectal ESD. The objective of this study was to investigate the efficacy of a water-jet function for colorectal ESD.


METHODS
This study was a prospective randomized controlled trial, which was conducted at a cancer referral center. A total of 49 patients, with a total of 51 superficial colorectal neoplasms (median tumor size of 30 mm), were enrolled and randomly assigned to undergo ESD using either the Flexknife (electrosurgical endo-knife without a water-jet function) or the Flushknife. Tumors were resected by ESD using each endo-knife. The procedures were conducted by two endoscopists. Operation time was defined as the main outcome measure.


RESULTS
En bloc resection was achieved in 23 out of 26 (88%) lesions in the Flexknife group and in 24 out of 24 (100%) lesions in the Flushknife group. The mean operation time (95% confidence interval) was 87.3 (71.3-103.4) min in the Flexknife group and 61.0 (49.3-72.7) min in the Flushknife group (P=0.02). The Flushknife reduced the number of endoscopic device changes (P=0.001), the number of submucosal injections (P=0.001), and the mean amount of injected hyaluronate sodium (P=0.001) compared with the Flexknife. No severe adverse events were observed in either group.


CONCLUSIONS
Without increasing adverse events, the endo-knife with a water-jet function efficiently reduced the operation time of colorectal ESD in patients with large superficial colorectal neoplasms. (University hospital Medical Information Network Clinical Trials Registry number UMIN000001302).
Takeuchi
Yoji
Y
Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan. takeuti-yo@mc.pref.osaka.jp
Uedo
Noriya
N
Ishihara
Ryu
R
Iishi
Hiroyasu
H
Kizu
Takashi
T
Inoue
Takuya
T
Chatani
Rika
R
Hanaoka
Noboru
N
Taniguchi
Tomoyasu
T
Kawada
Natsuko
N
Higashino
Koji
K
Shimokawa
Toshio
T
Tatsuta
Masaharu
M
D000236:Adenoma / Q000473:pathology / Q000601:surgery*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002277:Carcinoma / Q000473:pathology / Q000601:surgery*; D020685:Colonoscopes; D003113:Colonoscopy; D015179:Colorectal Neoplasms / Q000473:pathology / Q000601:surgery*; D004210:Dissection / Q000295:instrumentation; D004598:Electrosurgery / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D006801:Humans; D007413:Intestinal Mucosa / Q000473:pathology / Q000601:surgery; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D014867:Water
D014867:Water