title: Efficacy of a new hemostatic forceps during gastric endoscopic submucosal dissection: A prospective randomized controlled trial.
abstract: OBJECTIVE
  Currently, endoscopic submucosal dissection (ESD) is a widely accepted standard treatment for early gastric cancer, but one challenging aspect of ESD is hemostasis. We developed a new hemostatic forceps (FD-Y0007) with the aim of achieving more effective hemostasis and investigated the hemostatic ability of the FD-Y0007 during gastric ESD in humans.
  
  
  METHODS
  This study was a prospective randomized controlled trial, which was conducted at a cancer referral center. Sixty-six patients who were scheduled to undergo ESD were enrolled and randomly assigned to either the Coagrasper or the FD-Y0007, which was used for hemostasis throughout the case. The primary end point was the time required to obtain hemostasis, which was measured for the first episode of bleeding during each case.
  
  
  RESULTS
  Hemostasis time for the first bleeding episode during ESD was 73.0 s for the Coagrasper and 21.5 s for the FD-Y0007 (P < 0.001). When all episodes of bleeding were included, hemostasis time was 56.8 s in the Coagrasper group and 25.5 s in FD-Y0007group (P < 0.0001). The frequency of adverse events (perforation: 3.4% vs 7.1%; delayed bleeding: 0% vs 0%) was not significantly different between the two groups.
  
  
  CONCLUSIONS
  Compared with the Coagrasper, the FD-Y0007 efficiently reduces the hemostatic time during gastric ESD with no increase in adverse events.
authors.affiliation: Department of Endoscopy, Kobe University Hospital, Kobe, Japan.
authors.forename: Shinwa
authors.initials: S
authors.lastname: Tanaka
authors.affiliation: Department of Endoscopy, Kobe University Hospital, Kobe, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Toyonaga
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Graduate School of Medicine, Kobe University, Kobe, Japan.
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Morita
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Graduate School of Medicine, Kobe University, Kobe, Japan.
authors.forename: Tsukasa
authors.initials: T
authors.lastname: Ishida
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Graduate School of Medicine, Kobe University, Kobe, Japan.
authors.forename: Namiko
authors.initials: N
authors.lastname: Hoshi
authors.affiliation: Digestive Disease Center, Showa University Koto-Toyosu Hospital, Tokyo, Japan.
authors.forename: Kevin L
authors.initials: KL
authors.lastname: Grimes
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Graduate School of Medicine, Kobe University, Kobe, Japan.
authors.forename: Yoshiko
authors.initials: Y
authors.lastname: Ohara
authors.affiliation: Department of Endoscopy, Kobe University Hospital, Kobe, Japan.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Yoshizaki
authors.affiliation: Department of Endoscopy, Kobe University Hospital, Kobe, Japan.
authors.forename: Fumiaki
authors.initials: F
authors.lastname: Kawara
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Graduate School of Medicine, Kobe University, Kobe, Japan.
authors.forename: Eiji
authors.initials: E
authors.lastname: Umegaki
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Graduate School of Medicine, Kobe University, Kobe, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Azuma
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016099:Endoscopy, Gastrointestinal / Q000295:instrumentation*; D005260:Female; D005753:Gastric Mucosa / Q000601:surgery*; D006471:Gastrointestinal Hemorrhage / Q000517:prevention & control*; D016558:Hemostasis, Endoscopic / Q000295:instrumentation*; D006801:Humans; D007431:Intraoperative Complications / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000601:surgery*; D013525:Surgical Instruments; D013997:Time Factors; D016896:Treatment Outcome
keywords: adverse events; bleeding; gastric ESD; hemostatic forceps; hemostatic time