Peptic ulcer bleeding is a common disorder. Despite optimal endoscopic and medical treatment, there is a high risk of rebleeding and high mortality. In this study the investigators examine whether combined endoscopic haemostasis and angiographic embolization resolves in a better outcome than the traditional use of endoscopic haemostasis alone. The study is a randomised controlled trail.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Patients in the intervention arm receive supplementary angiographic embolization within 24 hours from the therapeutic endoscopy.
Patients are treated with standard therapeutic upper endoscopy including endoscopic combination therapy.
Odense University Hospital
Odense, Denmark
Composite Endpoint
Patients are classified into groups depending on the worst outcome: 1. No clinical signs of rebleeding and requirement of two or less blood transfusions after circulatory stabilization and obtained hemoglobin \> 5,9mmol/L. 2. No clinical signs of rebleeding and requirement of more than two blood transfusions after circulatory stabilization and obtained hemoglobin \> 5,9mmol/L. 3. Rebleeding and achieved secondary haemostasis by endoscopy or angiographic embolization. 4. Rebleeding requiring surgery. 5. Patients who have died. Results are compared using the Wilcoxon rank sum test.
Time frame: Meassured after a week from primary therapeutic endoscopy
Mortality
Patients who have died within af month from therapeutic endoscopy.
Time frame: 1 month
Rebleeding
Rebleeding from ulcer confirmed by endoscopy, angiography or surgery within a month from therapeutic endoscopy.
Time frame: 1 month
Blood transfusion
Amount of received blood transfusions after circulatory stabilization and obtained hemoglobin \> 5,9mmol/L. Patients will only receive blood transfusion if hemoglobin \< 6,0mmol/L
Time frame: 1 month
Surgical haemostasis
Rebleeding requiring surgical haemostasis within a month from therapeutic endoscopy.
Time frame: 1 month
Endoscopic/other haemostatic retreatment
Rebleeding confirmed by endoscopy or angiography and achieved secondary haemostasis by endoscopy or angiographic embolization.
Time frame: 1 month
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Duration of hospitalization
Time from hospitalization to discharge.
Time frame: Estimated 4 days
Thromboembolic complications
Occurence of thromboembolic complications due to angiographic embolization, surgery or therapeutic endoscopy.
Time frame: 1 month