Efficacy of Polysaccharide Hemostatic Powder on Blood Oozing Among Patients With Postendoscopic Sphincterotomy Bleeding: A Randomized Controlled Trial.

Abstract

Introduction: Postendoscopic 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 noninferiority to endoscopic clips in patients with nonpulsatile post-EST bleeding.

Methods: Patients with nonpulsatile post-EST bleeding were randomized to receive either PHP or endoscopic clips. The primary end point was the immediate hemostasis rate, with secondary end points including delayed bleeding rate, overall treatment success rate, mean hemostasis time, and other major complications.

Results: A total of 104 patients with nonpulsatile 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% confidence interval (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 (50.77 vs 62.81 seconds, P = 0.011). One delayed bleeding case (2.1%) occurred in the clip group, whereas none were observed in the PHP group. The overall treatment success rate was higher in the PHP group compared with the endoscopic clip group (100% vs 90.4%; P = 0.022). No differences were observed in adverse events.

Discussion: PHP is not inferior to endoscopic clip and could be of use in immediate hemostasis for nonpulsatile 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).