Back to results

Prophylactic Injection Therapy Reduces Recurrent Bleeding In Forrest Type IIb Duodenal Ulcers

Primary Purpose

Duodenal Ulcer Bleeding

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

prophylactic injection therapy

About this trial

This is an interventional prevention trial for Duodenal Ulcer Bleeding focused on measuring duodenal ulcer, upper gastrointestinal system bleeding, injection therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Endoscopic diagnose of Forrest type 2b duodenal ulcer.

Exclusion Criteria:

Patients at whom the onset of Upper Gastrointestinal system bleeding symptoms exceeded 24 hours at index endoscopy.
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.

Sites / Locations

Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Department of General Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

prophylactic injection therapy group

control group

Arm Description

In addition to medical therapy which included 2x 30 mg Pantoprazole and intravenous fluids this group of the patients recieved injection therapy.

This group of the patients recieved medical therapy only.

Outcomes

Primary Outcome Measures

Evidence of clinically definitive recurrent bleeding confirmed by upper gastrointestinal system endoscopy or surgery.

Secondary Outcome Measures

Full Information

NCT ID

NCT01471496

First Posted

November 1, 2011

Last Updated

November 10, 2011

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01471496

Brief Title

Prophylactic Injection Therapy Reduces Recurrent Bleeding In Forrest Type IIb Duodenal Ulcers

Official Title

Prophylactic Injection Therapy Reduces Recurrent Bleeding Rate In Forrest Type IIb Duodenal Ulcer Bleeding

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

January 2003 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine whether prophylactic injection therapy reduces recurrent bleeding rate for duodenal ulcers which has the endoscopic stigmata of recent bleeding.

Detailed Description

The benefit of endoscopic therapy in ulcers with adherent clots on their surface is still uncertain. A prophylactic injection therapy may reduce the recurrent bleeding rate at this group of patients having this endoscopic stigma of recent bleeding. This type of ulcers are named as type IIb duodenal ulcers according to Forrest's classification, They cary the risk of bleeding recurrence up to 36 percent and as it is reported previously there may be a 12 fold increasement in morbidity and mortality in such cases. A prophylactic endoscopic injection therapy may reduce the risk of recurrent bleeding in this group of the patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Duodenal Ulcer Bleeding

Keywords

duodenal ulcer, upper gastrointestinal system bleeding, injection therapy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

prophylactic injection therapy group

Arm Type

Experimental

Arm Description

In addition to medical therapy which included 2x 30 mg Pantoprazole and intravenous fluids this group of the patients recieved injection therapy.

Arm Title

control group

Arm Type

No Intervention

Arm Description

This group of the patients recieved medical therapy only.

Intervention Type

Procedure

Intervention Name(s)

prophylactic injection therapy

Other Intervention Name(s)

prophylactic sclerotherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Evidence of clinically definitive recurrent bleeding confirmed by upper gastrointestinal system endoscopy or surgery.

Time Frame

within first two days after index endoscopy

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Endoscopic diagnose of Forrest type 2b duodenal ulcer. Exclusion Criteria: Patients at whom the onset of Upper Gastrointestinal system bleeding symptoms exceeded 24 hours at index endoscopy. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Osman Z Öner, MD

Organizational Affiliation

Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Department of General Surgery, Istanbul, Turkey

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Department of General Surgery

City

Istanbul

ZIP/Postal Code

34147

Country

Turkey

12. IPD Sharing Statement

Citations:

PubMed Identifier

19446256

Citation

Cheung FK, Lau JY. Management of massive peptic ulcer bleeding. Gastroenterol Clin North Am. 2009 Jun;38(2):231-43. doi: 10.1016/j.gtc.2009.03.003.

Results Reference

background

PubMed Identifier

18206878

Citation

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.

Results Reference

background

PubMed Identifier

7717312

Citation

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.

Results Reference

background

PubMed Identifier

19528359

Citation

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.

Results Reference

background

PubMed Identifier

18387374

Citation

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.

Results Reference

background

PubMed Identifier

19006607

Citation

Kovacs TO. Management of upper gastrointestinal bleeding. Curr Gastroenterol Rep. 2008 Dec;10(6):535-42. doi: 10.1007/s11894-008-0099-3.

Results Reference

background

PubMed Identifier

8665233

Citation

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.

Results Reference

background

PubMed Identifier

2384031

Citation

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.

Results Reference

background

PubMed Identifier

14762781

Citation

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.

Results Reference

background

PubMed Identifier

21830

Citation

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.

Results Reference

background

PubMed Identifier

2693077

Citation

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.

Results Reference

background

PubMed Identifier

16457402

Citation

Ferguson CB, Mitchell RM. Non-variceal upper gastrointestinal bleeding. Ulster Med J. 2006 Jan;75(1):32-9. No abstract available.

Results Reference

background

PubMed Identifier

4136718

Citation

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.

Results Reference

background

PubMed Identifier

19188717

Citation

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.

Results Reference

background

PubMed Identifier

3596334

Citation

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.

Results Reference

background

PubMed Identifier

3068050

Citation

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.

Results Reference

background

PubMed Identifier

11197294

Citation

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.

Results Reference

background

PubMed Identifier

2070978

Citation

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.

Results Reference

background

PubMed Identifier

1530782

Citation

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.

Results Reference

background

PubMed Identifier

2327100

Citation

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.

Results Reference

background

PubMed Identifier

9925690

Citation

Cooper GS, Chak A, Way LE, Hammar PJ, Harper DL, Rosenthal GE. Early endoscopy in upper gastrointestinal hemorrhage: associations with recurrent bleeding, surgery, and length of hospital stay. Gastrointest Endosc. 1999 Feb;49(2):145-52. doi: 10.1016/s0016-5107(99)70478-5.

Results Reference

background

PubMed Identifier

18986845

Citation

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.

Results Reference

background

PubMed Identifier

16143125

Citation

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. Erratum In: Gastroenterology. 2006 Sep;131(3):980-1.

Results Reference

background

PubMed Identifier

12518133

Citation

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.

Results Reference

background

PubMed Identifier

8635701

Citation

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.

Results Reference

background

Learn more about this trial

Prophylactic Injection Therapy Reduces Recurrent Bleeding In Forrest Type IIb Duodenal Ulcers

We'll reach out to this number within 24 hrs