Standardized Papillary Hemospray Application for Immediate Post-Endoscopic Sphincterotomy Bleeding: A Historical-Control Cohort Study (with Video)

Background and aim To evaluate the feasibility and short-term safety of Hemospray as first-line hemostatic therapy for immediate post-endoscopic sphincterotomy (EST) bleeding using a standardized papillary application protocol, and to compare outcomes with a historical balloon-tamponade group. Methods The primary outcome was initial endoscopic hemostasis after first-line therapy. Key secondary outcomes were 30-day rebleeding, overall endoscopic hemostasis, rescue-device use, adverse events within 7 days, and exploratory device-cost comparison. Primary analyses included all eligible patients, categorized according to the first-line hemostatic therapy actually received, irrespective of subsequent rescue therapy. Results Among 1,666 EST procedures, 66 bleeding episodes required endoscopic hemostasis and were included (Hemospray, 25/498 [5.0%]; balloon tamponade, 41/1,168 [3.5%]); 21 episodes of self-limited oozing were excluded. Initial hemostasis was achieved more often with Hemospray than with balloon tamponade (96.0% vs 73.2%; risk difference 22.8%, 95% CI 4.3–41.4; P=0.023). Firth-penalized multivariable analysis supported this direction (adjusted odds ratio 7.7, 95% CI 1.5–84.2; P=0.013), although precision was limited by quasi-separation. In the propensity-score–matched analysis (20 pairs), initial hemostasis remained numerically higher with Hemospray (95.0% vs 80.0%; P=0.375). Overall endoscopic hemostasis was achieved in all patients. All rebleeding occurred within 24 hours and was numerically more frequent with Hemospray (12.0% vs 2.4%; P=0.14), with no additional events through 30 days. Adverse events occurred in 12.0% vs 22.0% (P=0.36). Conclusions A standardized Hemospray-first protocol was associated with improved initial bleeding control and reduced rescue-device use in persistent non-pulsatile post-EST oozing. However, overall endoscopic hemostasis was identical between groups, and hemostatic durability remains uncertain.