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

November 10, 2011 updated by: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34147
        • Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Department of General Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • prophylactic sclerotherapy
No Intervention: control group
This group of the patients recieved medical therapy only.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

  • Principal Investigator: Osman Z Öner, MD, Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Department of General Surgery, Istanbul, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

November 1, 2011

First Submitted That Met QC Criteria

November 10, 2011

First Posted (Estimate)

November 15, 2011

Study Record Updates

Last Update Posted (Estimate)

November 15, 2011

Last Update Submitted That Met QC Criteria

November 10, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • konuk-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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