title: Randomized study of two endo-knives for endoscopic submucosal dissection of esophageal cancer.
abstract: OBJECTIVE
  Settings for endoscopic submucosal dissection (ESD) of esophageal cancer have not been standardized, and no studies have directly compared ESD devices in humans.
  
  
  METHODS
  We conducted a randomized study to compare the performances of two different endo-knives, the Flush knife and Mucosectom, for esophageal ESD in 48 lesions. All procedures were initiated by two endoscopists, who were assisted by senior endoscopists with verbal advice. In the Flush-knife group, mucosal incision with a 2-mm Flush knife was followed by submucosal dissection using a 1-mm Flush knife. In the Mucosectom group, mucosal incision with a 2-mm Flush knife was followed by submucosal dissection with a Mucosectom. The primary outcome variable was the procedure time required for submucosal dissection. The secondary outcome variables were total procedure time, self-completion rates, and adverse events.
  
  
  RESULTS
  Total procedure time in the Mucosectom group was significantly shorter than in the Flush-knife group (57±21 vs. 83±27 min, respectively; P<0.001). The submucosal-dissection time in the Mucosectom group was significantly shorter than in the Flush-knife group (40±18 vs. 61±23 min, respectively; P<0.001). The self-completion rate in the Mucosectom group was slightly higher than in the Flush-knife group, but the difference was not significant (91.7% vs. 75%, respectively; P=0.25). One perforation and one postoperative bleeding occurred in the Flush-knife group, both of which were treated successfully by endoscopic treatment.
  
  
  CONCLUSIONS
  The Mucosectom reduced the procedure and submucosal-dissection times of esophageal ESD, without increasing adverse events.
authors.affiliation: Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Hiromitsu
authors.initials: H
authors.lastname: Kanzaki
authors.forename: Ryu
authors.initials: R
authors.lastname: Ishihara
authors.forename: Takashi
authors.initials: T
authors.lastname: Ohta
authors.forename: Kengo
authors.initials: K
authors.lastname: Nagai
authors.forename: Fumi
authors.initials: F
authors.lastname: Matsui
authors.forename: Takeshi
authors.initials: T
authors.lastname: Yamashina
authors.forename: Masao
authors.initials: M
authors.lastname: Hanafusa
authors.forename: Sachiko
authors.initials: S
authors.lastname: Yamamoto
authors.forename: Noboru
authors.initials: N
authors.lastname: Hanaoka
authors.forename: Yoji
authors.initials: Y
authors.lastname: Takeuchi
authors.forename: Koji
authors.initials: K
authors.lastname: Higashino
authors.forename: Noriya
authors.initials: N
authors.lastname: Uedo
authors.forename: Hiroyasu
authors.initials: H
authors.lastname: Iishi
authors.forename: Masaharu
authors.initials: M
authors.lastname: Tatsuta
mesh_terms: D000368:Aged; D001706:Biopsy; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000601:surgery*; D016009:Chi-Square Distribution; D004210:Dissection / Q000295:instrumentation*; D004938:Esophageal Neoplasms / Q000473:pathology / Q000601:surgery*; D004945:Esophagoscopy; D005260:Female; D006801:Humans; D008297:Male; D009092:Mucous Membrane / Q000601:surgery; D013525:Surgical Instruments; D016896:Treatment Outcome