The present study is a randomized controlled trial (RCT) that examines if the outcome of peptic ulcer bleeding could be improved by use of doppler-guided endoscopic treatment.
This study evaluates if performance of a control endoscopy with doppler-guided endoscopic treatment is associated with an improved outcome in term of lower rate of rebleeding and lower rate of bleeding-related mortality. A potential risk of increased risk of complications (in particular perforation) among patients treated with control endoscopy is also evaluated. Outcomes are prospectively registered based on patient records.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
125
Patients randomized to supplementary doppler-guided therapy undergo repeat endoscopy with doppler evaluation within 24 hours from the primary endoscopy. At the control endoscopy the ulcer base is examined using a doppler device. If active doppler flow is demonstrated the ulcer is treated with a thermal probe until a control doppler-scan is negative. All patients are observed for rebleeding at a specialized GI-bleeding unit.
All patients receive 80mg of Esomeprazole iv as a bolus followed by 8mg Esomeprazole per hour for 72 hours.
All patients are initially treated with endoscopic therapy using a minimum of two different treatment modalities. The primary endoscopy is performed wihtin 24 hours from time of admission to hospital
Department of gastrointestinal surgery, Aalborg University Hospital
Aalborg, Denmark
RECRUITINGDepartment of gastroenterology, Odense University Hospital
Odense, Denmark
RECRUITINGRebleeding
Number of participants who develop symptoms of rebleeding combined with a significant drop in systolic blood pressure, or B-haemoglobin, or confirmation of stigmata of bleeding at repeat endoscopy/angiography/surgery.
Time frame: 1 week
Bleeding-related mortality
Number of participants who die within 30 days from primary endoscopy because of severe rebleeding.
Time frame: 1 month
Complications to endoscopic therapy
Number of participants who develop complications to applied endoscopic therapy.
Time frame: 1 month
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