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

Not Applicable

Completed

• Conditions: Duodenal Ulcer Bleeding
• Interventions: Procedure: prophylactic injection therapy

• Registration Number: NCT01471496
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2011-11
• Study First Submitted: 2011-11-01
• Study First Submitted QC: 2011-11-10
• Last Update Submitted: 2011-11-10
• Study First Posted: 2011-11-15
• Last Update Posted: 2011-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Evidence of clinically definitive recurrent bleeding confirmed by upper gastrointestinal system endoscopy or surgery.	within first two days after index endoscopy

Trial Locations

Locations (1)

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