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Polysaccharide hemostatic powder to prevent bleeding after endoscopic submucosal dissection in high risk patients: a randomized controlled trialTrial Registration: ClinicalTrials.gov Registration number (trial ID): NCT03169569 Type of study: Prospective, Randomized, Multi-Center Study
Background Bleeding after endoscopic submucosal dissection (ESD) is a severe adverse event. Several methods to prevent post-ESD bleeding (PEB) have been introduced; however, they have not been widely used because of technical difficulties. We aimed to investigate whether polysaccharide hemostatic powder (PHP), which is very easy to apply, can prevent early post-ESD bleeding, especially in patients with a high risk of post-ESD bleeding.
Methods This was a prospective, multicenter, randomized, open-label, controlled trial. Patients with a high risk for post-ESD bleeding were enrolled. Patients with gastric neoplasms in whom the resected specimen size was expected to be > 40 mm and those who were regularly taking antithrombotic agents were defined as high risk patients. Patients were randomly assigned to the PHP or control groups.
Results Between May 2017 and September 2018, 143 patients were enrolled (PHP group, 73; control group, 70). The total post-ESD bleeding rate was 6.3 % (PHP group, 5.5 % vs. control group, 7.1 %; P = 0.74). There was no bleeding within 7 days after ESD in the PHP group. Continued antithrombotic use was an independent risk factor for post-ESD bleeding. In subgroup analysis excluding the patients who continued to take antithrombotic agents (n = 129) during ESD, the rate of post-ESD bleeding tended to be lower in the PHP group than in the control group (0 % vs. 6.3 %; P = 0.06).
Conclusion PHP did not demonstrate a significant effect on the prevention of post-ESD bleeding in this study. Further larger scale, randomized controlled trials are needed to confirm this.
* Equal first authors
Received: 09 June 2020
Accepted after revision: 17 November 2020
17 November 2020 (online)
© 2020. Thieme. All rights reserved.
Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany
- 1 Gu L, Khadaroo PA, Chen L. et al. Comparison of long-term outcomes of endoscopic submucosal dissection and surgery for early gastric cancer: a systematic review and meta-analysis. J Gastrointest Surg 2019; 23: 1493-1501
- 2 Li H, Feng LQ, Bian YY. et al. Comparison of endoscopic submucosal dissection with surgical gastrectomy for early gastric cancer: An updated meta-analysis. World J Gastrointest Oncol 2019; 11: 161-171
- 3 Kim YJ, Park DK. Management of complications following endoscopic submucosal dissection for gastric cancer. World J Gastrointest Endosc 2011; 3: 67-70
- 4 Goto O, Fujishiro M, Oda I. et al. A multicenter survey of the management after gastric endoscopic submucosal dissection related to postoperative bleeding. Dig Dis Sci 2012; 57: 435-439
- 5 Koh R, Hirasawa K, Yahara S. et al. Antithrombotic drugs are risk factors for delayed postoperative bleeding after endoscopic submucosal dissection for gastric neoplasms. Gastrointest Endosc 2013; 78: 476-483
- 6 Yano T, Tanabe S, Ishido K. et al. Different clinical characteristics associated with acute bleeding and delayed bleeding after endoscopic submucosal dissection in patients with early gastric cancer. Surg Endosc 2017; DOI: 10.1007/s00464-017-5513-1.
- 7 Park YM, Cho E, Kang HY. et al. The effectiveness and safety of endoscopic submucosal dissection compared with endoscopic mucosal resection for early gastric cancer: a systematic review and metaanalysis. Surg Endosc 2011; 25: 2666-2677
- 8 Dong J, Wei K, Deng J. et al. Effects of antithrombotic therapy on bleeding after endoscopic submucosal dissection. Gastrointest Endosc 2017; 86: 807-816
- 9 Shindo Y, Matsumoto S, Miyatani H. et al. Risk factors for postoperative bleeding after gastric endoscopic submucosal dissection in patients under antithrombotics. World J Gastrointest Endosc 2016; 8: 349-356
- 10 Takeuchi T, Ota K, Harada S. et al. The postoperative bleeding rate and its risk factors in patients on antithrombotic therapy who undergo gastric endoscopic submucosal dissection. BMC Gastroenterol 2013; 13: 136
- 11 Ono S, Fujishiro M, Yoshida N. et al. Thienopyridine derivatives as risk factors for bleeding following high risk endoscopic treatments: Safe Treatment on Antiplatelets (STRAP) study. Endoscopy 2015; 47: 632-637
- 12 Libanio D, Costa MN, Pimentel-Nunes P. et al. Risk factors for bleeding after gastric endoscopic submucosal dissection: a systematic review and meta-analysis. Gastrointest Endosc 2016; 84: 572-586
- 13 Sato C, Hirasawa K, Koh R. et al. Postoperative bleeding in patients on antithrombotic therapy after gastric endoscopic submucosal dissection. World J Gastroenterol 2017; 23: 5557-5566
- 14 Kataoka Y, Tsuji Y, Sakaguchi Y. et al. Bleeding after endoscopic submucosal dissection: Risk factors and preventive methods. World J Gastroenterol 2016; 22: 5927-5935
- 15 Hasuike N, Ono H, Boku N. et al. A non-randomized confirmatory trial of an expanded indication for endoscopic submucosal dissection for intestinal-type gastric cancer (cT1a): the Japan Clinical Oncology Group study (JCOG0607). Gastric Cancer 2018; 21: 114-123
- 16 Lee BI, Kim BW, Kim HK. et al. Routine mucosal closure with a detachable snare and clips after endoscopic submucosal dissection for gastric epithelial neoplasms: a randomized controlled trial. Gut Liver 2011; 5: 454-459
- 17 Kantsevoy SV, Bitner M, Mitrakov AA. et al. Endoscopic suturing closure of large mucosal defects after endoscopic submucosal dissection is technically feasible, fast, and eliminates the need for hospitalization (with videos). Gastrointest Endosc 2014; 79: 503-507
- 18 Tsuji Y, Fujishiro M, Kodashima S. et al. Polyglycolic acid sheets and fibrin glue decrease the risk of bleeding after endoscopic submucosal dissection of gastric neoplasms (with video). Gastrointest Endosc 2015; 81: 906-912
- 19 Hahn KY, Park JC, Lee YK. et al. Efficacy of hemostatic powder in preventing bleeding after gastric endoscopic submucosal dissection in high-risk patients. J Gastroenterol Hepatol 2018; 33: 656-663
- 20 Choe YH, Park JC, Kim YJ. et al. Sa1227. Predictive risk model for post-endoscopic submucosal dissection ulcer bleeding of stomach: single center cohort study. Gastrointest Endosc 2018; 87: AB173-AB174
- 21 Prei JC, Barmeyer C, Burgel N. et al. EndoClot polysaccharide hemostatic system in nonvariceal gastrointestinal bleeding: results of a prospective multicenter observational pilot study. J Clin Gastroenterol 2016; 50: e95-e100
- 22 Chung IK, Lee JH, Lee SH. et al. Therapeutic outcomes in 1000 cases of endoscopic submucosal dissection for early gastric neoplasms: Korean ESD Study Group multicenter study. Gastrointest Endosc 2009; 69: 1228-1235
- 23 Takizawa K, Oda I, Gotoda T. et al. Routine coagulation of visible vessels may prevent delayed bleeding after endoscopic submucosal dissection--an analysis of risk factors. Endoscopy 2008; 40: 179-183
- 24 Beg S, Al-Bakir I, Bhuva M. et al. Early clinical experience of the safety and efficacy of EndoClot in the management of non-variceal upper gastrointestinal bleeding. Endosc Int Open 2015; 3: E605-E609
- 25 Kaehler G, Dutenhoefner C, Magdeburg R. Endoscopic application of polysaccharide powder for hemostasis in anticoagulated pigs (with video). Gastrointest Endosc 2015; 82: 161-163
- 26 Yano T, Tanabe S, Ishido K. et al. Different clinical characteristics associated with acute bleeding and delayed bleeding after endoscopic submucosal dissection in patients with early gastric cancer. Surg Endosc 2017; 31: 4542-4550
- 27 Nam HS, Choi CW, Kim SJ. et al. Risk factors for delayed bleeding by onset time after endoscopic submucosal dissection for gastric neoplasm. Sci Rep 2019; 9: 2674
- 28 Kono Y, Obayashi Y, Baba Y. et al. Postoperative bleeding risk after gastric endoscopic submucosal dissection during antithrombotic drug therapy. J Gastroenterol Hepatol 2018; 33: 453-460
- 29 Shindo Y, Matsumoto S, Miyatani H. et al. Risk factors for postoperative bleeding after gastric endoscopic submucosal dissection in patients under antithrombotics. World J Gastrointest Endosc 2016; 8: 349-356
- 30 Kataoka Y, Tsuji Y, Hirasawa K. et al. Endoscopic tissue shielding to prevent bleeding after endoscopic submucosal dissection: a prospective multicenter randomized controlled trial. Endoscopy 2019; 51: 619-627
- 31 Takizawa K, Oda I, Gotoda T. et al. Routine coagulation of visible vessels may prevent delayed bleeding after endoscopic submucosal dissection. An analysis of risk factors. Endoscopy 2008; 40: 179-183
- 32 Uedo N, Takeuchi Y, Yamada T. et al. Effect of a proton pump inhibitor or an H2-receptor antagonist on prevention of bleeding from ulcer after endoscopic submucosal dissection of early gastric cancer: a prospective randomized controlled trial. Am J Gastroenterol 2007; 102: 1610-1616