Hemostatic spray powder TC-325 in the primary endoscopic treatment of peptic ulcer-related bleeding: multicenter international registry

Abstract

Background Upper gastrointestinal bleeding (UGIB) is a leading cause of morbidity and is associated with a 2 % – 17 % mortality rate in the UK and USA. Bleeding peptic ulcers account for 50 % of UGIB cases. Endoscopic intervention in a timely manner can improve outcomes. Hemostatic spray is an endoscopic hemostatic powder for GI bleeding. This multicenter registry was created to collect data prospectively on the immediate endoscopic hemostasis of GI bleeding in patients with peptic ulcer disease when hemostatic spray is applied as endoscopic monotherapy, dual therapy, or rescue therapy.

Methods Data were collected prospectively (January 2016 – March 2019) from 14 centers in the UK, France, Germany, and the USA. The application of hemostatic spray was decided upon at the endoscopist’s discretion.

Results 202 patients with UGIB secondary to peptic ulcers were recruited. 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.

Conclusions This is the largest case series of outcomes of peptic ulcer bleeding treated with hemostatic spray, with high immediate hemostasis rates for bleeding peptic ulcers.

• References

• 1 Lanas A, Aabakken L, Fonseca J. et al. Clinical predictors of poor outcomes among patients with nonvariceal upper gastrointestinal bleeding in Europe. Aliment Pharmacol Ther 2011; 33: 1225-1233
• 2 McPherson SJ, Sinclair MT, Smith NCE. et al. Time to get control? A review of the care received by patients who had a severe gastrointestinal haemorrhage. London, UK: National Confidential Enquiry into Patient Outcome and Death; 2015
• 3 Alzoubaidi D, Lovat LB, Haidry R. Management of non-variceal upper gastrointestinal bleeding: where are we in 2018?. Frontline Gastroenterol 2019; 10: 35-42
• 4 Van Leerdamm ME. Epidemiology of acute upper gastrointestinal bleeding. Best Pract Res Clin Gastroenterol 2008; 22: 209-224
• 5 Babiuc RD, Purcarea M, Sadagurschi R. et al. Use of Hemospray in the treatment of patients with acute UGIB – short review. J Med Life 2013; 6: 117-119
• 6 Lau JYW, Barkun A, Fan D. et al. Challenges in the management of acute peptic ulcer bleeding. Lancet 2013; 381: 2033-2043
• 7 Cahyadi O, Bauder M, Meier B. et al. Effectiveness of TC-325 (Hemospray) for treatment of diffuse or refractory upper gastrointestinal bleeding – a single centre experience. Endosc Int Open 2017; 05: E1159-E1164
• 8 Ibrahim M, El-Mikkawy A, Abdel Hamid M. et al. Early application of haemostatic powder added to standard management for oesophagpgastric variceal bleeding: a randomised trial. Gut 2019; 68: 844-853
• 9 Kwek BEA, Ang TL, Ong PLJ. et al. TC-325 versus the conventional combined technique for endoscopic treatment of peptic ulcers with high-risk bleeding stigmata: a randomized pilot study. J Dig Dis 2017; 18: 323-329
• 10 Facciorusso A, Straus Takahashi M, Eyileten Postula C. et al. Efficacy of hemostatic powders in upper gastrointestinal bleeding: a systematic review and meta-analysis. Dig Liver Dis 2019; 51: 1633-1640
• 11 Hemospray^® Endoscopic Hemostat. Cook Medical. Available from (Accessed: 10 June 2019): https://www.cookmedical.com/products/35a4a7f2-867b-4c81-a983-44ea06277852/
• 12 Mokhtare M, Bozorgi V, Agah S. et al. Comparison of Glasgow-Blatchford score and full Rockall score systems to predict clinical outcomes in patients with upper gastrointestinal bleeding. Clin Exp Gastroenterol 2016; 9: 337-343
• 13 Blatchford O, Murray WR, Blatchford M. A risk score to predict need for treatment for upper gastrointestinal haemorrhage. Lancet 2000; 356: 1318-1321
• 14 Monteiro S, Goncalves TC, Magalhaes J. et al. Upper gastrointestinal bleeding risk scores: who, when and why?. World J Gastrointest Pathophysiol 2006; 7: 86-96
• 15 Forrest JH, Finlayson NDC, Shearman DJC. Endoscopy in gastrointestinal bleeding. Lancet 1974; 304: 394-397
• 16 Nayor J, Saltzman JR. Determining the endpoint of endoscopic therapy for upper GI bleeding: are our eyes as good as our ears?. Gastrointest Endosc 2016; 83: 137-139
• 17 Gralnek IM, Dumonceau JM, Ernst JK. et al. Diagnosis and management of nonvariceal upper gastrointestinal haemorrhage: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy 2015; 47: a1-a46
• 18 Sung JJY, Luo D, Wu JCY. et al. Early clinical experience of the safety and effectiveness of Hemospray in achieving hemostasis in patients with acute peptic ulcer bleeding. Endoscopy 2011; 43: 291-295
• 19 Masso Gonzalez EL, Garcoa Rodriguez LA. Proton pump inhibitors reduce the long-term risk of recurrent upper gastrointestinal bleeding: an observational study. Aliment Pharmacol Ther 2008; 28: 629-637
• 20 Laine L, Spiegel B, Rostom A. et al. Methodology for randomized trials of patients with nonvariceal upper gastrointestinal bleeding: recommendations from an international consensus conference. Am J Gastroenterol 2010; 105: 540-550
• 21 Wong S, Sung J. Management of GI emergencies: peptic ulcer acute bleeding. Best Pract Res Clin Gastroenterol 2013; 27: 639-647
• 22 Sinha R, Lockman K, Church N. et al. The use of of hemostatic spray as an adjunct to conventional hemostatic measures in high-risk non-variceal upper GI bleeding. Gastrointest Endosc 2016; 84: 900-906
• 23 Holster IL, Kuipers EJ, Tjwa ET. Hemospray in the treatment of upper gastrointestinal haemorrhage in patients on antithrombotic therapy. Endoscopy 2013; 45: 63-66
• 24 Haddara S, Jacques J, Lecleire S. et al. A novel hemostatic powder for upper gastrointestinal bleeding: a multicentre study (the ‘GRAPHE’ registry). Endoscopy 2016; 48: 1084-1095
• 25 Tang Y, Shen J, Zheng F. et al. Scoring systems used to predict mortality in patients with acute upper gastrointestinal bleeding in the ED. Am J Emerg Med 2018; 36: 27-32
• 26 Wang CY, Qin J, Sun CY. et al. Rockall score in predicting outcomes of elderly patients with acute upper gastrointestinal bleeding. World J Gastroenterol 2013; 19: 3466-3472
• 27 Marmo R, Rotandano G, Piscopo R. et al. Dual therapy versus monotherapy in the endoscopic treatment of high-risk bleeding ulcers: a meta-analysis of controlled trials. Am J Gastroenterol 2007; 102: 279-289
• 28 Chen Y-I, Barkun A, Nolan S. Hemostatic powder TC-325 in the management of upper and lower gastrointestinal bleeding: a two year experience at a single institution. Endoscopy 2015; 47: 167-171
• 29 Yau AHL, Ou G, Galorport C. et al. Safety and efficacy of Hemospray in upper gastrointestinal bleeding. Can J Gastroenterol Hepatol 2014; 28: 72-76
• 30 Hearnshaw SA, Logan RFA, Lower D. et al. Use of endoscopy for management of acute upper gastrointestinal bleeding in the UK: results of a nationwide audit. Gut 2010; 59: 1022-1029
• 31 Schmidt A, Golder S, Goetz M. et al. Over-the-scope clips are more effective than standard endoscopic therapy for patients with recurrent bleeding of peptic ulcers. Gastroenterology 2018; 155: 674-686