Early clinical experience of the safety and efficacy of EndoClot in the management of non-variceal upper gastrointestinal bleeding

Abstract

BACKGROUND AND STUDY AIMS EndoClot is a novel topical hemostatic powder approved for use in non-variceal upper gastrointestinal bleeding. This study examines its impact as rescue therapy in the management of gastrointestinal bleeding for which standard endoscopic therapy failed to achieve hemostasis. METHODS This observational study covered a 24-month period. Data were collated from patients treated with EndoClot for comparison with a cohort of patients managed with standard endoscopic therapy. End points of this study included immediate hemostasis, 30-day rebleed rate, 30-day mortality rate, and adverse events. RESULTS Between April 1, 2012, and March 31, 2014, gastroscopic procedures were performed in 1009 patients, of whom 173 required endoscopic therapy. EndoClot was used in 21 patients, with immediate hemostasis achieved in all cases, a 30-day rebleed rate of 4.8 % (95 % confidence interval [95 %CI] - 4.34 % to 3.94 %), and a 30-day mortality rate of 19.0 % (95 %CI 2.29 % - 35.91 %). Despite higher risk bleeds in this cohort of patients, Fisher's exact test demonstrated no significant difference between their 30-day mortality rate (P = 0.51) and rebleed rate (P = 0.31) and those of the patients treated with standard endoscopic hemostatic techniques. CONCLUSIONS This study demonstrates that EndoClot can be used both safely and effectively in the management of non-variceal upper gastrointestinal bleeding.