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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
  1. Satoshi Mochizuki1,
  2. Noriya Uedo2,
  3. Ichiro Oda3,
  4. Kazuhiro Kaneko4,
  5. Yorimasa Yamamoto5,
  6. Takeshi Yamashina2,
  7. Haruhisa Suzuki3,
  8. Shinya Kodashima1,
  9. Tomonori Yano4,
  10. Nobutake Yamamichi1,
  11. Osamu Goto6,
  12. Takeshi Shimamoto7,
  13. Mitsuhiro Fujishiro1,8,
  14. Kazuhiko Koike1
  15. and The SAFE Trial Study Group
  1. 1Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
  2. 2Department of Gastrointestinal Oncology, Osaka Medical Centre for Cancer and Cardiovascular Diseases, Osaka, Japan
  3. 3Endoscopy Division, National Cancer Centre Hospital, Tokyo, Japan
  4. 4Department of Gastroenterology, Endoscopy division, National Cancer Centre Hospital East, Kashiwa, Japan
  5. 5Endoscopy Division, Gastrointestinal Centre, Cancer Institute Hospital, Tokyo, Japan
  6. 6Division of Research and Development for Minimally Invasive Treatment, Cancer Centre, School of Medicine, Keio University, Tokyo, Japan
  7. 7Department of Statistics and Information Management, Kameda Medical Centre Makuhari, Chiba, Japan
  8. 8Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
  1. Correspondence to Dr Mitsuhiro Fujishiro, Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan; mtfujish-kkr{at}


Objective To clarify the effectiveness of second-look endoscopy (SLE) at preventing bleeding after gastric endoscopic submucosal dissection (ESD).

Design 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.

Trial registration number UMIN-CTR000007170.


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