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

Satoshi Mochizuki, Noriya Uedo, Ichiro Oda, Kazuhiro Kaneko, Yorimasa Yamamoto, Takeshi Yamashina, Haruhisa Suzuki, Shinya Kodashima, Tomonori Yano, Nobutake Yamamichi, Osamu Goto, Takeshi Shimamoto, Mitsuhiro Fujishiro, Kazuhiko Koike

Research output: Contribution to journalArticle

34 Citations (Scopus)

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); p<inf>non-inferiority</inf><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.

Original languageEnglish
Pages (from-to)397-405
Number of pages9
JournalGut
Volume64
Issue number3
DOIs
Publication statusPublished - 2015 Mar 1

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Endoscopy
Multicenter Studies
Stomach Neoplasms
Hemorrhage
Stomach
Non-Randomized Controlled Trials
Endoscopic Mucosal Resection
Intention to Treat Analysis
Proton Pump Inhibitors
Japan
Anti-Inflammatory Agents
Radiotherapy
Referral and Consultation
Steroids
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Gastroenterology
  • Medicine(all)

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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. / 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.

In: Gut, Vol. 64, No. 3, 01.03.2015, p. 397-405.

Research output: Contribution to journalArticle

Mochizuki, S, Uedo, N, Oda, I, Kaneko, K, Yamamoto, Y, Yamashina, T, Suzuki, H, Kodashima, S, Yano, T, Yamamichi, N, Goto, O, Shimamoto, T, Fujishiro, M & Koike, K 2015, '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', Gut, vol. 64, no. 3, pp. 397-405. https://doi.org/10.1136/gutjnl-2014-307552
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. / 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. In: Gut. 2015 ; Vol. 64, No. 3. pp. 397-405.
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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.",
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T2 - A multicentre prospective randomised controlled non-inferiority trial

AU - Mochizuki, Satoshi

AU - Uedo, Noriya

AU - Oda, Ichiro

AU - Kaneko, Kazuhiro

AU - Yamamoto, Yorimasa

AU - Yamashina, Takeshi

AU - Suzuki, Haruhisa

AU - Kodashima, Shinya

AU - Yano, Tomonori

AU - Yamamichi, Nobutake

AU - Goto, Osamu

AU - Shimamoto, Takeshi

AU - Fujishiro, Mitsuhiro

AU - Koike, Kazuhiko

PY - 2015/3/1

Y1 - 2015/3/1

N2 - 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.

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.

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