title: Scheduled second-look endoscopy is not recommended after endoscopic submucosal dissection for gastric neoplasms (the SAFE trial): a multicentre prospective randomised controlled non-inferiority trial.
abstract: OBJECTIVE
  To clarify the effectiveness of second-look endoscopy (SLE) at preventing bleeding after gastric endoscopic submucosal dissection (ESD).
  
  
  METHODS
  A multicentre prospective randomised controlled non-inferiority trial was conducted at five referral institutions across Japan. Patients with a solitary gastric neoplasm were enrolled. Exclusion criteria were previous oesophagogastric surgery or radiation therapy; perforation and the administration of antithrombotics, steroids or non-steroidal anti-inflammatory drugs. Patients were assigned to the SLE group or the non-SLE group by a computer-generated random sequence after ESD and were treated perioperatively with a proton pump inhibitor. SLE was performed one day after ESD. The primary endpoint was post-ESD bleeding, defined as an endoscopically proven haemorrhage. The trial had the power to detect a non-inferiority criterion of 7% between the groups.
  
  
  RESULTS
  From February 2012 to February 2013, 130 and 132 patients were assigned to the SLE and the non-SLE groups, respectively. All patients were included in the intention-to-treat analysis of the primary endpoint. Post-ESD bleeding occurred in seven patients with (5.4%) SLE and five patients with (3.8%) non-SLE (risk difference--1.6% (95% CI -6.7 to 3.5); pnon-inferiority<0.001), meeting the non-inferiority criterion. All 12 patients with post-ESD bleeding and one patient with a delayed perforation were successfully managed with conservative treatment.
  
  
  CONCLUSIONS
  SLE after gastric ESD is not routinely recommended because it does not contribute to the prevention of post-ESD bleeding for patients with an average bleeding risk.
  
  
  BACKGROUND
  UMIN-CTR000007170.
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Mochizuki
authors.affiliation: Department of Gastrointestinal Oncology, Osaka Medical Centre for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Noriya
authors.initials: N
authors.lastname: Uedo
authors.affiliation: Endoscopy Division, National Cancer Centre Hospital, Tokyo, Japan.
authors.forename: Ichiro
authors.initials: I
authors.lastname: Oda
authors.affiliation: Department of Gastroenterology, Endoscopy division, National Cancer Centre Hospital East, Kashiwa, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Kaneko
authors.affiliation: Endoscopy Division, Gastrointestinal Centre, Cancer Institute Hospital, Tokyo, Japan.
authors.forename: Yorimasa
authors.initials: Y
authors.lastname: Yamamoto
authors.affiliation: Department of Gastrointestinal Oncology, Osaka Medical Centre for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Yamashina
authors.affiliation: Endoscopy Division, National Cancer Centre Hospital, Tokyo, Japan.
authors.forename: Haruhisa
authors.initials: H
authors.lastname: Suzuki
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Shinya
authors.initials: S
authors.lastname: Kodashima
authors.affiliation: Department of Gastroenterology, Endoscopy division, National Cancer Centre Hospital East, Kashiwa, Japan.
authors.forename: Tomonori
authors.initials: T
authors.lastname: Yano
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Nobutake
authors.initials: N
authors.lastname: Yamamichi
authors.affiliation: Division of Research and Development for Minimally Invasive Treatment, Cancer Centre, School of Medicine, Keio University, Tokyo, Japan.
authors.forename: Osamu
authors.initials: O
authors.lastname: Goto
authors.affiliation: Department of Statistics and Information Management, Kameda Medical Centre Makuhari, Chiba, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Shimamoto
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Mitsuhiro
authors.initials: M
authors.lastname: Fujishiro
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Koike
mesh_terms: D000368:Aged; D005260:Female; D005773:Gastroscopy / Q000009:adverse effects / Q000379:methods*; D006489:Hemostatic Techniques; D006801:Humans; D008297:Male; D019106:Postoperative Hemorrhage / Q000175:diagnosis / Q000517:prevention & control; D024162:Second-Look Surgery / Q000379:methods; D013274:Stomach Neoplasms / Q000175:diagnosis / Q000601:surgery*
keywords: GASTRIC CANCER; GASTRIC SURGERY; GASTROINTESINAL ENDOSCOPY; GASTROINTESTINAL BLEEDING; SURGICAL COMPLICATIONS