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. Issue 3 (9th October 2014)

• Record Type: Journal Article
• Authors: Mochizuki, Satoshi; Uedo, Noriya; Oda, Ichiro; Kaneko, Kazuhiro; Yamamoto, Yorimasa; Yamashina, Takeshi; Suzuki, Haruhisa; Kodashima, Shinya; Yano, Tomonori; Yamamichi, Nobutake; Goto, Osamu; Shimamoto, Takeshi; Fujishiro, Mitsuhiro; Koike, Kazuhiko
• Other Names: Shinozaki Tomohiro author non-byline.; Yoshinaga Shigetaka author non-byline.; Nonaka Satoru author non-byline.; Abe Seiichiro author non-byline.; Ohno Yasuhiro author non-byline.; Odagaki Tomoyuki author non-byline.; Yagishita Atsushi author non-byline.; Yoda Yusuke author non-byline.; Kato Tomoji author non-byline.; Ono Satoshi author non-byline.; Niimi Keiko author non-byline.; Tsuji Yosuke author non-byline.; Asada-Hirayama Itsuko author non-byline.; Konno-Shimizu Maki author non-byline.; Matsuda Rie author non-byline.; Minatsuki Chihiro author non-byline.; Sakaguchi Yoshiki author non-byline.; Takahahi Yu author non-byline.; Nakayama Chiemi author non-byline.; Yoshida Kanako author non-byline.
• Is Part Of: Gut. Volume 64:Issue 3(2015)
• Page Start: 397
• Page End: 405
• Publication Date: 2014-10-09
• Subjects: GASTRIC CANCER -- GASTRIC SURGERY -- GASTROINTESINAL ENDOSCOPY -- GASTROINTESTINAL BLEEDING -- SURGICAL COMPLICATIONS; Gastroenterology -- Periodicals; 616.33
• DOI: 10.1136/gutjnl-2014-307552
• Languages: English
• ISSNs: 0017-5749

Abstract

Abstract : 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.