Hemospray effective endoscopic modality for treating bleeding peptic ulcer, finds study
According to a recent study report, Hemospray is effective in achieving immediate hemostasis in bleeding peptic ulcer disease and seems to be most effective when used in conjunction with other endoscopic modalities. The findings have been published in Gastroenterology.
A number of therapeutic options have been available for years. Their respective efficacies depend on, to a certain extent, the etiology of the bleeding, whether the bleeding is occurring in the upper or lower gastrointestinal tract, and whether the bleeding is malignant or nonmalignant. Even within nonmalignant bleeding, there exist various causes, including ulcers or nonulcer etiologies with varying natural histories.
TC-325 (Hemospray) belongs to a family of products called hemostatic powders. This agent consists of small mineral granules that achieve hemostasis. TC-325 binds to actively bleeding sites, and the granules absorb all of the water from blood or secretions, and then swell and adhere to the bleeding sites, essentially acting like a bandage over the hemorrhagic lesion. This is the main mechanism by which TC-325 is thought to act, although much remains uncertain about additional roles of the powder.
Researchers performed a multicenter international registry study evaluating the efficacy of hemostatic spray powder TC-325 (Hemospray; Cook Medical) in achieving immediate endoscopic hemostasis when used as monotherapy, dual therapy, or rescue therapy in patients with bleeding peptic ulcer disease. The study was a single blinded randomized controlled trial of 101 patients undergoing endoscopic submucosal dissection (ESD) for 2- to 5-cm lesions treated in the esophagus or colon. Randomized patients received PuraStat or diathermy for grades 1/2 intraprocedural bleeding outside the immediate vicinity of the tip of the knife, or when the bleeding point was not easily accessible to diathermy. Routine end-of-procedure complete coverage of the resection base was achieved in all PuraStat patients.
Data analysis revealed the following facts.
- The overall immediate hemostasis rate was 88%, and the overall rebleeding rate at 30 days was 17%.
- Immediate hemostasis was achieved in 178/202 patients (88 %), 26/154 (17 %) experienced rebleeding, 21/175 (12 %) died within 7 days, and 38/175 (22 %) died within 30 days (all-cause mortality). Combination therapy of hemostatic spray with other endoscopic modalities had an associated lower 30-day mortality (16 %, P < 0.05) compared with monotherapy or rescue therapy. There were high immediate hemostasis rates across all peptic ulcer disease Forrest classifications.
- There was no difference in hemostasis rate, rebleeding rate, or 7-day mortality when Hemospray was used as monotherapy, dual therapy, or rescue therapy, but combination therapy was associated with a lower 30-day all-cause mortality rate (32% for monotherapy, 16% for combination therapy, and 25% for rescue therapy; P < .05).
Observing the results, the team wrote, "These data further confirm Hemospray endotherapy feasibility and effectiveness in achieving immediate hemostasis. Its role as monotherapy in peptic ulcer bleeding remains unclear as the included IIa and IIb patients would not expect to benefit from Hemospray as no active bleeding lesions present for the product to bind to."
For the full article follow the link: Endoscopy 2021 Jan 01;53(1)36-43, M Hussein, D Alzoubaidi, MF Lopez, M Weaver, J Ortiz-Fernandez-Sordo, P Bassett, JW Rey, BH Hayee, E Despott, A Murino, S Moreea, P Boger, J Dunn, I Mainie, D Graham, DK Mullady, DS Early, K Ragunath, JT Anderson, P Bhandari, M Goetz, R Kiesslich, E Coron, LB Lovat, R Haidry
Primary source: Gastroenterology
