drugset / Trial / NCT05345613
Tranexamic Acid During Colonic Endoscopic Resection Procedures
RandomizedParallel-groupSingle-blindPrevention
Summary
Colonoscopy with polypectomy reduces the incidence and mortality associated with colon cancer. However, polypectomy is associated with adverse events such as bleeding. Tranexamic acid (TXA) is a synthetic derivative of lysine that exerts antifibrinolytic effects and may prevent bleeding. The investigators aim to evaluate the effect of local TXA on preventing intraprocedural and postprocedural bleeding in patients undergoing endoscopic mucosal resection (EMR) of large colon polyps.
Timeline
- Start
- 2022-05-01
- Primary completion
- 2026-09-01
- Completion
- 2026-10-01
Publications
- Background ASGE Technology Committee; Hwang JH, Konda V, Abu Dayyeh BK, Chauhan SS, Enestvedt BK, Fujii-Lau LL, Komanduri S, Maple JT, Murad FM, Pannala R, Thosani NC, Banerjee S. Endoscopic mucosal resection. Gastrointest Endosc. 2015 Aug;82(2):215-26. doi: 10.1016/j.gie.2015.05.001. Epub 2015 Jun 12.
- Background Park CH, Lee SK. Preventing and controlling bleeding in gastric endoscopic submucosal dissection. Clin Endosc. 2013 Sep;46(5):456-62. doi: 10.5946/ce.2013.46.5.456. Epub 2013 Sep 30.
- Background Fahrtash-Bahin F, Holt BA, Jayasekeran V, Williams SJ, Sonson R, Bourke MJ. Snare tip soft coagulation achieves effective and safe endoscopic hemostasis during wide-field endoscopic resection of large colonic lesions (with videos). Gastrointest Endosc. 2013 Jul;78(1):158-163.e1. doi: 10.1016/j.gie.2013.02.030. Epub 2013 Apr 6.
- Background Lee HS, Jeon SW, Kwon YH, Nam SY, Shin S, Kim R, Ahn S. Prophylactic endoscopic coagulation to prevent delayed post-EMR bleeding in the colorectum: a prospective randomized controlled trial (with videos). Gastrointest Endosc. 2019 Nov;90(5):813-822. doi: 10.1016/j.gie.2019.05.039. Epub 2019 Jun 5.
- Background Liaquat H, Rohn E, Rex DK. Prophylactic clip closure reduced the risk of delayed postpolypectomy hemorrhage: experience in 277 clipped large sessile or flat colorectal lesions and 247 control lesions. Gastrointest Endosc. 2013 Mar;77(3):401-7. doi: 10.1016/j.gie.2012.10.024. Epub 2013 Jan 11.
- Background Castro R, Libanio D, Pita I, Dinis-Ribeiro M. Solutions for submucosal injection: What to choose and how to do it. World J Gastroenterol. 2019 Feb 21;25(7):777-788. doi: 10.3748/wjg.v25.i7.777.
- Background Rex DK, Lahr RE, Peterson MM, Vemulapalli KC. Impact of including epinephrine in the submucosal injectate for colorectal EMR on postprocedural pain: a randomized controlled trial. Gastrointest Endosc. 2022 Mar;95(3):535-539.e1. doi: 10.1016/j.gie.2021.11.043. Epub 2021 Dec 9.
- Background Cai J, Ribkoff J, Olson S, Raghunathan V, Al-Samkari H, DeLoughery TG, Shatzel JJ. The many roles of tranexamic acid: An overview of the clinical indications for TXA in medical and surgical patients. Eur J Haematol. 2020 Feb;104(2):79-87. doi: 10.1111/ejh.13348. Epub 2019 Dec 16.
- Background Watts G. Utako Okamoto. Lancet. 2016 Jun 4;387(10035):2286. doi: 10.1016/s0140-6736(16)30697-3. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Epinephrine | Other / unclassified | — | Other |
| Subject | Tranexamic Acid | Small molecule | — | Other |