Hemostatic spray (TC-325) vs. standard endoscopic therapy for non-variceal gastrointestinal bleeding: A meta-analysis of randomized controlled trials.

• Type of Material: Article
• Authors: Smit S Deliwala, Emory University; Saurabh Chandan, Creighton University; Babu P Mohan, University of Utah; Shahab Khan, Harvard Medical School; Nitin Reddy, PSG Institute of Medical Science; Daryl Ramai, University of Utah Health; Jay A Bapaye, Rochester General Hospital; Dushyant Singh Dahiya, University College of Medicine; Lena L Kassab, Mayo Clinic, Rochester, Minnesota, United States.; Antonio Facciorusso, Gastroenterology Unit, University of Foggia, Foggia, Italy.; Saurabh Chawla, Emory University; Douglas Adler, Center for Advanced Therapeutic Endoscopy, Centura Health, Denver, Colorado, United States.
• Language: English
• Date: 2023-03
• Publisher: Georg Thieme Verlag KG
• Publication Version: Final Published Version
• Copyright Statement: The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1055/a-2032-4199
• Title of Journal or Parent Work: Endosc Int Open
• Volume: 11
• Issue: 3
• Start Page: E288
• End Page: E295
• Keywords: standard endoscopic therapy; Hemostatic spray
• Research Categories: Health Sciences, Medicine and Surgery

Abstract

Background and study aims  Hemospray (TC-325) is a mineral powder with adsorptive properties designed for use in various gastrointestinal bleeding (GIB) scenarios. We conducted a systematic review & meta-analysis of randomized controlled trials (RCTs) comparing TC-325 to standard endoscopic therapy (SET) for non-variceal GIB (NVGIB). Methods  Multiple databases were searched through October 2022. Meta-analysis was performed using a random-effects model to determine pooled relative risk (RR) and proportions with 95 % confidence intervals (CI) for primary hemostasis, hemostasis failure, 30-day rebleeding, length of stay (LOS), and need for rescue interventions. Heterogeneity was assessed using I 2 %. Results  Five RCTs with 362 patients (TC-325 178, SET 184) - 123 females and 239 males with a mean age 65 ± 16 years). The most common etiologies were peptic ulcer disease (48 %), malignancies (35 %), and others (17 %). Bleeding was characterized as Forrest IA (7 %), IB (73 %), IIA (3 %), and IIB (1 %). SET included epinephrine injection, electrocautery, hemoclips, or a combination. No statistical difference in primary hemostasis between TC-325 compared to SET, RR 1.09 (CI 0.95-1.25; I 2 43), P =  0.2, including patients with oozing/spurting hemorrhage, RR 1.13 (CI 0.98-1.3; I 2 35), P =  0.08. Failure to achieve hemostasis was higher in SET compared to TC-325, RR 0.30 (CI 0.12-0.77, I 2 0), P =  0.01, including patients with oozing/spurting hemorrhage, RR 0.24 (CI 0.09 - 0.63, I 2 0), P =  0.004. We found no difference between the two interventions in terms of rebleeding, RR 1.13 (CI 0.62-2.07, I 2 26), P =  0.8 and LOS, standardized mean difference (SMD) 0.27 (CI, -0.20-0.74; I 2 62), P =  0.3. Finally, pooled rate of rescue interventions (angiography) was statistically higher in SET compared to TC-325, RR 0.68 (CI 0.5-0.94; I 2 0), P =  0.02. Conclusions  Our analysis shows that for acute NV GIB, including oozing/spurting hemorrhage, TC-325 does not result in higher rates of primary hemostasis compared to SET. However, lower rates of failures were seen with TC-325 than SET. In addition, there was no difference in the two modalities when comparing rates of rebleeding and LOS.