RT Journal Article
SR Electronic
T1 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
JF Gut
JO Gut
FD BMJ Publishing Group Ltd and British Society of Gastroenterology
SP 397
OP 405
DO 10.1136/gutjnl-2014-307552
VO 64
IS 3
A1 Satoshi Mochizuki
A1 Noriya Uedo
A1 Ichiro Oda
A1 Kazuhiro Kaneko
A1 Yorimasa Yamamoto
A1 Takeshi Yamashina
A1 Haruhisa Suzuki
A1 Shinya Kodashima
A1 Tomonori Yano
A1 Nobutake Yamamichi
A1 Osamu Goto
A1 Takeshi Shimamoto
A1 Mitsuhiro Fujishiro
A1 Kazuhiko Koike
YR 2015
UL http://gut.bmj.com/content/64/3/397.abstract
AB 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.