Clinical trial NCT01471496: Prophylactic Injection Therapy Reduces Recurrent Bleeding In Forrest Type IIb Duodenal Ulcers
Official title: Prophylactic Injection Therapy Reduces Recurrent Bleeding Rate In Forrest Type IIb Duodenal Ulcer Bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Duodenal Ulcer Bleeding
Keywords: duodenal ulcer
upper gastrointestinal system bleeding
injection therapy
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2011-11-15
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evidence of clinically definitive recurrent bleeding confirmed by upper gastrointestinal system endoscopy or surgery.
timeFrame: within first two days after index endoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Department of General Surgery
Study officials:
affiliation: Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Department of General Surgery, Istanbul, Turkey
name: Osman Z Öner, MD
role: PRINCIPAL_INVESTIGATOR
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