Randomized controlled trial of hemostatic powder versus endoscopic clipping for non-variceal upper gastrointestinal bleeding
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Background and aims
Despite advances in pharmacological and endoscopic management of non-variceal upper gastrointestinal bleeding (NVUGIB), mortality is still relevant. TC-325 (Hemospray-Cook Medical) is a mineral powder with adsorptive properties, designed for endoscopic hemostasis. There are still no comparative trials studying this new hemostatic modality. The objective of this research was to compare the use of TC-325 (associated with epinephrine injection) with the combined technique of endoscopic clipping and epinephrine injection for the treatment of patients with NVUGIB.
We conducted a pilot randomized controlled trial with patients that presented NVUGIB with an actively bleeding lesion at the endoscopic evaluation. Patients were randomized either to the Hemospray or Hemoclip group. The randomization list was generated by a computer program and remained unknown throughout the entire trial. All patients underwent second-look endoscopy.
Thirty-nine patients were enrolled. Peptic ulcer was the most frequent etiology. Primary hemostasis was achieved in all Hemospray cases and in 90% of Hemoclip group (p = 0.487). Five patients in Hemospray group underwent an additional hemostatic procedure during second-look endoscopy, while no patient in the Hemoclip group needed it (p = 0.04). Rebleeding, emergency surgery and mortality rates were similar in both groups. No toxicity, allergy events, or gastrointestinal obstruction signs were observed in Hemospray group.
TC-325 presents similar hemostatic results when compared with conventional dual therapy for patients with NVUGIB. Hemospray’s excellent primary hemostasis rate certifies it as a valuable tool in arduous situations of severe bleeding or difficult location site.
KeywordsGastrointestinal bleeding Endoscopic hemostasis Hemospray Randomized controlled trial
Compliance with ethical standards
Felipe Iankelevich Baracat, Diogo Turiani Hourneaux de Moura, Vítor Ottoboni Brunaldi, Caio Vinicius Tranquillini, Renato Baracat, Paulo Sakai, and Eduardo Guimarães Hourneaux de Moura declare that they have no conflict of interest or financial ties to disclose.
- 6.Sreedharan A, Martin J, Leontiadis GI, Dorward S, Howden CW, Forman D, Moayyedi P (2010) Proton pump inhibitor treatment initiated prior to endoscopic diagnosis in upper gastrointestinal bleeding. Cochrane Database Syst Rev 7:CD005415Google Scholar
- 10.Smith LA, Stanley AJ, Bergman JJ, Kiesslich R, Hoffman A, Tjwa ET, Kuipers EJ, von Holstein CS, Oberg S, Brullet E, Schmidt PN, Iqbal T, Mangiavillano B, Masci E, Prat F, Morris AJ (2014) Hemospray application in nonvariceal upper gastrointestinal bleeding: results of the Survey to Evaluate the Application of Hemospray in the Luminal Tract. J Clin Gastroenterol 48(10):e89–e92Google Scholar
- 18.SNOMED CT (2018) Systematised Nomenclature fo Medicine Clinical Terms. http://www.nlm.nih.gov/research/ulms/Snomed/snomed_main.html. Accessed 23 Sept 2018
- 22.Haddara S, Jacques J, Lecleire S, Branche J, Leblanc S, Le Baleur Y, Privat J, Heyries L, Bichard P, Granval P, Chaput U, Koch S, Levy J, Godart B, Charachon A, Bourgaux JF, Metivier-Cesbron E, Chabrun E, Quentin V, Perrot B, Vanbiervliet G, Coron E (2016) A novel hemostatic powder for upper gastrointestinal bleeding: a multicenter study (the “GRAPHE” registry). Endoscopy 48(12):1084–1095CrossRefGoogle Scholar
- 25.Chen Y-I, Barkun A, Nolan S (2015) Hemostatic powder TC-325 in the man- agement of upper and lower gastrointestinal bleeding: a two-year ex- perience at a single institution. Endoscopy 47:167–171Google Scholar