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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Duodenal Ulcer Bleeding

Intervention / Treatment
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* Procedure: prophylactic injection therapy


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prophylactic injection therapy group<br>In addition to medical therapy which included 2x 30 mg Pantoprazole and intravenous fluids this group of the patients recieved injection therapy. | Procedure: prophylactic injection therapy<br>* 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.<br>* Other names: prophylactic sclerotherapy;|
| No Intervention: control group<br>This group of the patients recieved medical therapy only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of clinically definitive recurrent bleeding confirmed by upper gastrointestinal system endoscopy or surgery. |  | within first two days after index endoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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duodenal ulcer, upper gastrointestinal system bleeding, injection therapy