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

Duodenal Ulcer Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01471496
• Other study ID #: konuk-001
• Status: Completed
• Phase: N/A
• First received: November 1, 2011
• Last updated: November 10, 2011
• Start date: January 2003
• Est. completion date: October 2009

Study information

• Verified date: November 2011
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Duodenal Ulcer
• Duodenal Ulcer Bleeding
• Hemorrhage
• Ulcer

Intervention

Procedure:
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of clinically definitive recurrent bleeding confirmed by upper gastrointestinal system endoscopy or surgery.		within first two days after index endoscopy	No