Efficacy of Polysaccharide Hemostatic Powder on blood oozing among patients with Post-Endoscopic Sphincterotomy Bleeding: A Randomized Controlled Trial

Background and Aims: Post-endoscopic sphincterotomy (EST) bleeding presents challenges for endoscopists using side-viewing duodenoscopes. Recently, polysaccharide hemostatic powder (PHP) has shown promising results in managing gastrointestinal hemorrhage. Given the established efficacy of endoscopic clips in addressing post-EST bleeding, we aim to evaluate the efficacy of PHP and its non-inferiority to endoscopic clips in patients with non-pulsatile post-EST bleeding. Methods: Patients with non-pulsatile post-EST bleeding were randomized to receive either PHP or endoscopic clips. The primary endpoint was the immediate hemostasis rate, with secondary endpoints including delayed bleeding rate, overall treatment success rate, mean hemostasis time, and other major complications. Results: A total of 104 patients with non-pulsatile post-EST bleeding were included. Immediate hemostasis was achieved in 100% of the PHP group and 92.3% in the endoscopic clip group (risk difference, 7.7%, 95% CI = 0.5 – 15.0%, P = 0.022). Four patients in the endoscopic clip group experienced immediate hemostasis failure. Hemostasis time was shorter in the PHP group (50.77s vs. 62.81s, P = 0.011). One delayed bleeding case (2.1%) occurred in the clip group, while none were observed in the PHP group. The overall treatment success rate was higher in the PHP group compared to the endoscopic clip group (100% vs. 90.4%; P = 0.022). No differences were observed in adverse events. Conclusions: PHP is not inferior to endoscopic clip and could be of use in immediate hemostasis for non-pulsatile post-EST bleeding, with the added advantage of ease of use. Further research is needed to assess its efficacy in preventing delayed bleeding. (chictr.org.cn, ChiCTR2400092280)