Prophylactic Injection Therapy Reduces Recurrent Bleeding In Forrest Type IIb Duodenal Ulcers
NCT ID: NCT01471496
Last Updated: 2011-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2003-01-31
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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prophylactic injection therapy group
In addition to medical therapy which included 2x 30 mg Pantoprazole and intravenous fluids this group of the patients recieved injection therapy.
prophylactic injection therapy
Standard application of endoscopic injection therapy as it is used for actively bleeding ulcers, 10 ml of serum saline with 1/10000 epinephrine is submucosally injected to the four quadrants of the ulcer margins.
control group
This group of the patients recieved medical therapy only.
No interventions assigned to this group
Interventions
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prophylactic injection therapy
Standard application of endoscopic injection therapy as it is used for actively bleeding ulcers, 10 ml of serum saline with 1/10000 epinephrine is submucosally injected to the four quadrants of the ulcer margins.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients having hemodynamic instability: systolic blood pressure below 90 mm/hg, heart rate above 110/min
* Demonstration of hemoglobin fall more than 2 g/dl in two hours.
* Patients with coexisting ulcers elsewhere than in duodenum.
* Patients under anticoagulant therapy other than Aspirin.
ALL
No
Sponsors
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Bakirkoy Dr. Sadi Konuk Research and Training Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Osman Z Öner, MD
Role: PRINCIPAL_INVESTIGATOR
Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Department of General Surgery, Istanbul, Turkey
Locations
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Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Department of General Surgery
Istanbul, , Turkey (Türkiye)
Countries
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References
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Enestvedt BK, Gralnek IM, Mattek N, Lieberman DA, Eisen G. An evaluation of endoscopic indications and findings related to nonvariceal upper-GI hemorrhage in a large multicenter consortium. Gastrointest Endosc. 2008 Mar;67(3):422-9. doi: 10.1016/j.gie.2007.09.024. Epub 2008 Jan 18.
Yavorski RT, Wong RK, Maydonovitch C, Battin LS, Furnia A, Amundson DE. Analysis of 3,294 cases of upper gastrointestinal bleeding in military medical facilities. Am J Gastroenterol. 1995 Apr;90(4):568-73.
Pilotto A, Maggi S, Noale M, Franceschi M, Parisi G, Crepaldi G; IPOD Investigators. Development and validation of a new questionnaire for the evaluation of upper gastrointestinal symptoms in the elderly population: a multicenter study. J Gerontol A Biol Sci Med Sci. 2010 Feb;65(2):174-8. doi: 10.1093/gerona/glp073. Epub 2009 Jun 15.
Cappell MS, Friedel D. Initial management of acute upper gastrointestinal bleeding: from initial evaluation up to gastrointestinal endoscopy. Med Clin North Am. 2008 May;92(3):491-509, xi. doi: 10.1016/j.mcna.2008.01.005.
Kovacs TO. Management of upper gastrointestinal bleeding. Curr Gastroenterol Rep. 2008 Dec;10(6):535-42. doi: 10.1007/s11894-008-0099-3.
Kubba AK, Palmer KR. Role of endoscopic injection therapy in the treatment of bleeding peptic ulcer. Br J Surg. 1996 Apr;83(4):461-8. doi: 10.1002/bjs.1800830408.
Chung SC, Leung JW, Leung FW. Effect of submucosal epinephrine injection on local gastric blood flow. A study using laser Doppler flowmetry and reflectance spectrophotometry. Dig Dis Sci. 1990 Aug;35(8):1008-11. doi: 10.1007/BF01537250.
Calvet X, Vergara M, Brullet E, Gisbert JP, Campo R. Addition of a second endoscopic treatment following epinephrine injection improves outcome in high-risk bleeding ulcers. Gastroenterology. 2004 Feb;126(2):441-50. doi: 10.1053/j.gastro.2003.11.006.
Green FW Jr, Kaplan MM, Curtis LE, Levine PH. Effect of acid and pepsin on blood coagulation and platelet aggregation. A possible contributor prolonged gastroduodenal mucosal hemorrhage. Gastroenterology. 1978 Jan;74(1):38-43.
Heldwein W, Schreiner J, Pedrazzoli J, Lehnert P. Is the Forrest classification a useful tool for planning endoscopic therapy of bleeding peptic ulcers? Endoscopy. 1989 Nov;21(6):258-62. doi: 10.1055/s-2007-1010729.
Ferguson CB, Mitchell RM. Non-variceal upper gastrointestinal bleeding. Ulster Med J. 2006 Jan;75(1):32-9. No abstract available.
Forrest JA, Finlayson ND, Shearman DJ. Endoscopy in gastrointestinal bleeding. Lancet. 1974 Aug 17;2(7877):394-7. doi: 10.1016/s0140-6736(74)91770-x. No abstract available.
Peter S, Wilcox CM. Modern endoscopic therapy of peptic ulcer bleeding. Dig Dis. 2008;26(4):291-9. doi: 10.1159/000177011. Epub 2009 Jan 30.
Armstrong CP, Blower AL. Non-steroidal anti-inflammatory drugs and life threatening complications of peptic ulceration. Gut. 1987 May;28(5):527-32. doi: 10.1136/gut.28.5.527.
Balanzo J, Sainz S, Such J, Espinos JC, Guarner C, Cusso X, Mones J, Vilardell F. Endoscopic hemostasis by local injection of epinephrine and polidocanol in bleeding ulcer. A prospective randomized trial. Endoscopy. 1988 Nov;20(6):289-91. doi: 10.1055/s-2007-1013023.
Buffoli F, Graffeo M, Nicosia F, Gentile C, Cesari P, Rolfi F, Paterlini A. Peptic ulcer bleeding: comparison of two hemostatic procedures. Am J Gastroenterol. 2001 Jan;96(1):89-94. doi: 10.1111/j.1572-0241.2001.03456.x.
Hui WM, Ng MM, Lok AS, Lai CL, Lau YN, Lam SK. A randomized comparative study of laser photocoagulation, heater probe, and bipolar electrocoagulation in the treatment of actively bleeding ulcers. Gastrointest Endosc. 1991 May-Jun;37(3):299-304. doi: 10.1016/s0016-5107(91)70719-0.
Cook DJ, Guyatt GH, Salena BJ, Laine LA. Endoscopic therapy for acute nonvariceal upper gastrointestinal hemorrhage: a meta-analysis. Gastroenterology. 1992 Jan;102(1):139-48. doi: 10.1016/0016-5085(92)91793-4.
Branicki FJ, Coleman SY, Fok PJ, Pritchett CJ, Fan ST, Lai EC, Mok FP, Cheung WL, Lau PW, Tuen HH, et al. Bleeding peptic ulcer: a prospective evaluation of risk factors for rebleeding and mortality. World J Surg. 1990 Mar-Apr;14(2):262-9; discussion 269-70. doi: 10.1007/BF01664889.
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Laine L, McQuaid KR. Endoscopic therapy for bleeding ulcers: an evidence-based approach based on meta-analyses of randomized controlled trials. Clin Gastroenterol Hepatol. 2009 Jan;7(1):33-47; quiz 1-2. doi: 10.1016/j.cgh.2008.08.016. Epub 2008 Aug 16.
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.
Marmo R, Rotondano G, Bianco MA, Piscopo R, Prisco A, Cipolletta L. Outcome of endoscopic treatment for peptic ulcer bleeding: Is a second look necessary? A meta-analysis. Gastrointest Endosc. 2003 Jan;57(1):62-7. doi: 10.1067/mge.2003.48.
Laine L, Stein C, Sharma V. A prospective outcome study of patients with clot in an ulcer and the effect of irrigation. Gastrointest Endosc. 1996 Feb;43(2 Pt 1):107-10. doi: 10.1016/s0016-5107(06)80109-4.
Other Identifiers
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konuk-001
Identifier Type: -
Identifier Source: org_study_id