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.

Efficacy of hemostatic powder in preventing bleeding after gastric endoscopic submucosal dissection in high‐risk patients

“…AMP® particles absorb water to form a gelled matrix that shields the ulcer surface for 3-48 h and causes a local concentration of coagulating factors. 20,36 In previous animal studies, polysaccharide hemostatic powder derived from modified starch could improve impaired wound healing 37 and was able to stop active ulcer bleeding from iatrogenic mucosal ulcers by snaring in pigs receiving antithrombotic therapy. Compared to the mechanical methods such as overstitch endoscopic suturing device, detachable snare, and clips, Endo-Clot ™ is more easy to use and there is no further tissue injury to the post-resection ulcer surface because the catheter of Endo-Clot ™ does not need to directly contact the ulcer surface.…”

“…Endo‐Clot™ is biocompatible absorbable hemostatic polysaccharides. AMP® particles absorb water to form a gelled matrix that shields the ulcer surface for 3–48 h and causes a local concentration of coagulating factors . In previous animal studies, polysaccharide hemostatic powder derived from modified starch could improve impaired wound healing and was able to stop active ulcer bleeding from iatrogenic mucosal ulcers by snaring in pigs receiving antithrombotic therapy.…”

Effectiveness of the polysaccharide hemostatic powder in non‐variceal upper gastrointestinal bleeding: Using propensity score matching

“…We ensured that the powder chamber was held upright during insertion of the catheter through the working channel of the endoscope. The high flow of air during insertion of the powder prevents wet particles from clotting during the powder application process …”

“…Acute upper gastrointestinal bleeding (UGIB) is a common condition worldwide, with an estimated annual incidence of 40–150 cases per 100 000 individuals; UGIB frequently leads to hospital admission and is associated with significant mortality rates, which have been reported to range between 6% and 15% . The mortality rate of UGIB tends to be higher because of its common incidence in the elderly population, as well as due to the increased use of antiplatelet therapies, anticoagulants, and, more recently, novel oral anticoagulants for cardiovascular disease …”

“…Acute upper gastrointestinal bleeding (UGIB) is a common condition worldwide, with an estimated annual incidence of 40-150 cases per 100 000 individuals; UGIB frequently leads to hospital admission and is associated with significant mortality rates, 1 which have been reported to range between 6% and 15%. [2][3][4][5][6][7] The mortality rate of UGIB tends to be higher because of its common incidence in the elderly population, as well as due to the increased use of antiplatelet therapies, anticoagulants, and, more recently, novel oral anticoagulants for cardiovascular disease. [7][8][9][10] Currently, endoscopic hemostasis is accepted as a first-line treatment modality in the management of UGIB and has been demonstrated to be effective in reducing the rate of rebleeding, the need for surgical intervention, and mortality.…”