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

Bakirkoy Dr. Sadi Konuk Research and Training Hospital80 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Duodenal Ulcer Bleeding

Interventions

prophylactic injection therapyPROCEDURE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

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

Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

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

Time frame: within first two days after index endoscopy

Data from ClinicalTrials.gov

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