Different Dose of Intravenous Omeprazole to Treat Bleeding Ulcer With Adherent Clot

Summary

The investigators will include those patients with adherent clot on gastric or duodenal ulcers after endoscopic confirmation After receiving well explanation and giving written consent, they are enrolled and will be allocated to 2 groups randomly. Those in the first group will receive intravenous omeprazole 40 mg stat and then 40 mg q12h. Those in the second group will receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion. The patients in both groups will receive intravenous omeprazole for 3 days and then oral esomeprazole qd for further treatment of peptic ulcer. The investigators define rebleeding during admission and within 30 days as primary end points and define surgical intervention for ulcer bleeding, transfusion amount and hospitalization days after allocation as secondary end points.

Timeline

Start

2009-03

Primary completion

2012-06

Completion

2012-07

Publications

• Background Martins NB, Wassef W. Upper gastrointestinal bleeding. Curr Opin Gastroenterol. 2006 Nov;22(6):612-9. doi: 10.1097/01.mog.0000245542.95408.5d.
• Background Rollhauser C, Fleischer DE. Nonvariceal upper gastrointestinal bleeding. Endoscopy. 2004 Jan;36(1):52-8. doi: 10.1055/s-2004-814114.
• Background Jung HK, Son HY, Jung SA, Yi SY, Yoo K, Kim DY, Moon IH, Lee HC. Comparison of oral omeprazole and endoscopic ethanol injection therapy for prevention of recurrent bleeding from peptic ulcers with nonbleeding visible vessels or fresh adherent clots. Am J Gastroenterol. 2002 Jul;97(7):1736-40. doi: 10.1111/j.1572-0241.2002.05780.x.
• Background Bleau BL, Gostout CJ, Sherman KE, Shaw MJ, Harford WV, Keate RF, Bracy WP, Fleischer DE. Recurrent bleeding from peptic ulcer associated with adherent clot: a randomized study comparing endoscopic treatment with medical therapy. Gastrointest Endosc. 2002 Jul;56(1):1-6. doi: 10.1067/mge.2002.125365.
• Background Sung JJ, Chan FK, Lau JY, Yung MY, Leung WK, Wu JC, Ng EK, Chung SC. The effect of endoscopic therapy in patients receiving omeprazole for bleeding ulcers with nonbleeding visible vessels or adherent clots: a randomized comparison. Ann Intern Med. 2003 Aug 19;139(4):237-43. doi: 10.7326/0003-4819-139-4-200308190-00005.
• Background Sheu BS, Chi CH, Huang CC, Kao AW, Wang YL, Yang HB. Impact of intravenous omeprazole on Helicobacter pylori eradication by triple therapy in patients with peptic ulcer bleeding. Aliment Pharmacol Ther. 2002 Jan;16(1):137-43. doi: 10.1046/j.1365-2036.2002.01137.x.
• Background Lin HJ, Lo WC, Cheng YC, Perng CL. Role of intravenous omeprazole in patients with high-risk peptic ulcer bleeding after successful endoscopic epinephrine injection: a prospective randomized comparative trial. Am J Gastroenterol. 2006 Mar;101(3):500-5. doi: 10.1111/j.1572-0241.2006.00399.x.
• Background Lau JY, Leung WK, Wu JC, Chan FK, Wong VW, Chiu PW, Lee VW, Lee KK, Cheung FK, Siu P, Ng EK, Sung JJ. Omeprazole before endoscopy in patients with gastrointestinal bleeding. N Engl J Med. 2007 Apr 19;356(16):1631-40. doi: 10.1056/NEJMoa065703.
• Background Swain CP, Kirkham JS, Salmon PR, Bown SG, Northfield TC. Controlled trial of Nd-YAG laser photocoagulation in bleeding peptic ulcers. Lancet. 1986 May 17;1(8490):1113-7. doi: 10.1016/s0140-6736(86)91835-0.
• Background Kahi CJ, Jensen DM, Sung JJ, Bleau BL, Jung HK, Eckert G, Imperiale TF. Endoscopic therapy versus medical therapy for bleeding peptic ulcer with adherent clot: a meta-analysis. Gastroenterology. 2005 Sep;129(3):855-62. doi: 10.1053/j.gastro.2005.06.070.
• Background Jensen DM, Kovacs TO, Jutabha R, Machicado GA, Gralnek IM, Savides TJ, Smith J, Jensen ME, Alofaituli G, Gornbein J. Randomized trial of medical or endoscopic therapy to prevent recurrent ulcer hemorrhage in patients with adherent clots. Gastroenterology. 2002 Aug;123(2):407-13. doi: 10.1053/gast.2002.34782.
• Background Laine L, Freeman M, Cohen H. Lack of uniformity in evaluation of endoscopic prognostic features of bleeding ulcers. Gastrointest Endosc. 1994 Jul-Aug;40(4):411-7. doi: 10.1016/s0016-5107(94)70202-0.
• Background Lau JY, Sung JJ, Chan AC, Lai GW, Lau JT, Ng EK, Chung SC, Li AK. Stigmata of hemorrhage in bleeding peptic ulcers: an interobserver agreement study among international experts. Gastrointest Endosc. 1997 Jul;46(1):33-6. doi: 10.1016/s0016-5107(97)70206-2.
• Background Swain CP, Storey DW, Bown SG, Heath J, Mills TN, Salmon PR, Northfield TC, Kirkham JS, O'Sullivan JP. Nature of the bleeding vessel in recurrently bleeding gastric ulcers. Gastroenterology. 1986 Mar;90(3):595-608. doi: 10.1016/0016-5085(86)91113-3.
• Background Laine L, Peterson WL. Bleeding peptic ulcer. N Engl J Med. 1994 Sep 15;331(11):717-27. doi: 10.1056/NEJM199409153311107. No abstract available.
• Background Katschinski B, Logan R, Davies J, Faulkner G, Pearson J, Langman M. Prognostic factors in upper gastrointestinal bleeding. Dig Dis Sci. 1994 Apr;39(4):706-12. doi: 10.1007/BF02087411.
• Background Consensus conference: Therapeutic endoscopy and bleeding ulcers. JAMA. 1989 Sep 8;262(10):1369-72. No abstract available.

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Indications