Polysaccharide hemostatic powder to prevent bleeding after endoscopic submucosal dissection in high risk patients: a randomized controlled trial.

Abstract

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.

• Authors: Da Hyun Jung, Hee Seok Moon, Chan Hyuk Park, Jun Chul Park
• Journal: Endoscopy (Endoscopy) Vol. 53 Issue 10 Pg. 994-1002 (10 2021) ISSN: 1438-8812 [Electronic] Germany
• PMID: 33200808 (Publication Type: Clinical Trial, Multicenter Study, Randomized Controlled Trial)
• Copyright: Thieme. All rights reserved.

Chemical References

• Hemostatics
• Polysaccharides
• Powders

Topics

• Endoscopic Mucosal Resection (adverse effects)
• Gastric Mucosa (surgery)
• Hemostatics
• Humans
• Polysaccharides (therapeutic use)
• Postoperative Hemorrhage (etiology, prevention & control)
• Powders
• Prospective Studies
• Risk Factors
• Stomach Neoplasms (surgery)