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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01471496

Enrollment

Registered

2011-11-15

Start date

2003-01-31

Completion date

2009-10-31

Last updated

2011-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duodenal Ulcer Bleeding

Keywords

duodenal ulcer, upper gastrointestinal system bleeding, injection therapy

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.

Interventions

PROCEDUREprophylactic 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026