Hemospray for Life-Threatening Gastrointestinal Bleeding Secondary to Ulcer Disease: First Case Report in the United States Presidential Poster

Abstract

Purpose: Acute upper GI hemorrhage causes 300,000 annual U.S. hospital admissions with a mortality rate of 10%. In some cases, hemostasis is difficult to achieve secondary to anatomy or severe bleeding which is not amenable to currently available therapies. Hemospray powder (Cook Endoscopy) is a novel approach currently pending FDA approval for hemostasis of nonvariceal peptic ulcer bleeding. Hemospray is a granular, mineral blend nanopowder with clotting abilities which acts by increasing the concentration of clotting factors, activating platelets, and forming a mechanical plug on an injured blood vessel. Here we report the first case in the U.S. in which Hemospray was used to treat a patient in the clinical setting. Our patient was a 13yo male with metastatic rhabdomyosarcoma with pancreatic head mass and biliary obstruction secondary to CBD stricture. Patient underwent ERCP with fully covered SEMS placement. Subsequently, he redeveloped jaundice along with vomiting. EGD revealed that the stent had migrated distally and embedded into the contralateral duodenal wall, with a large bleeding ulcer where the stent was embedded. There was also diffuse erythema and edema with oozing proximal to this area. Endoscopic therapy was not feasible and patient underwent IR embolization of the gastroduodenal artery. Over the next week, patient was monitored in the PICU and required multiple blood transfusions. He also developed thrombocytopenia requiring platelet transfusions. Despite repeat IR embolization and medical therapy with PPI and octreotide drips, active bleeding persisted. The surgical service deemed him a non-surgical candidate. Given his life-threatening condition with persistent active bleeding and no feasible medical or surgical option, we obtained approval for use of Hemospray. EGD was performed revealing erythematous, edematous, friable antral mucosa with a mosaic pattern. An adherent clot was seen at the pyloric channel and removed with irrigation and aspiration, revealing an oozing ulcer. The duodenum was also erythematous and edematous. There was diffuse oozing in the antrum and duodenum along with re-identification of the duodenal ulcer, not amenable to conventional therapy. A total of 25 to 30 grams of Hemospray powder was applied to the duodenal ulcer site, the proximal duodenum, the antrum, and the pyloric channel site. After application, there was no evidence of oozing or active bleeding. The patient tolerated the procedure well and he was discharged home six days later with no further episodes of bleeding. To our knowledge, this is the first successful use of Hemospray for the management of upper gastrointestinal bleeding outside of a clinical trial.