Background and aims: 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 PEB, especially in patients with high risk of PEB.
Methods: This was a prospective, multicenter, randomized, open-label, controlled trial. Patients with a high risk for PEB 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 group.
Results: Between May 2017 and September 2018, 143 patients were enrolled (PHP group: 73, control group: 70). The total PEB rate was 6.3% (PHP group: 5% vs. control group: 7.1%, P=0.742). There was no bleeding within 7 days after ESD in the PHP group. Continued antithrombotic use was an independent risk factor of PEB. In subgroup analysis excluding patients who continued to take antithrombotics (n=129) during ESD, the rate of PEB was tended to be lower in the PHP group than in the control group (0% vs. 6.3%, P=0.058).
Conclusion: PHP did not demonstrate a significant effect on the prevention of PEB in this study. Further larger-scale, randomized controlled trials are needed to confirm this.(ClinicalTrials.gov 03169569)
Risk factors of major intraoperative bleeding and postoperative bleeding associated with endoscopic submucosal dissection for gastric neoplasms
