Supplementary Angiographic Embolization for Peptic Ulcer Bleeding
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|ClinicalTrials.gov Identifier: NCT01125852|
Recruitment Status : Completed
First Posted : May 19, 2010
Last Update Posted : May 14, 2013
|Condition or disease||Intervention/treatment||Phase|
|Peptic Ulcer Hemorrhage||Procedure: Angiographic embolization Procedure: Therapeutic endoscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Supplementary Angiographic Embolization for Peptic Ulcer Bleeding: A Randomized Controlled Trial|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
Active Comparator: Intervention group
Patients in this group are treated with usual therapeutic endoscopy including endoscopic combination therapy and 72 hours intravenous proton pump inhibitor. Within 24 hours from the therapeutic endoscopy they receive supplementary angiographic embolization.
Procedure: Angiographic embolization
Patients in the intervention arm receive supplementary angiographic embolization within 24 hours from the therapeutic endoscopy.
Active Comparator: Control group
Patients in this arm receive standard treatment including therapeutic endoscopy with endoscopic combination therapy followed by 72 hours intravenous proton pump inhibitor.
Procedure: Therapeutic endoscopy
Patients are treated with standard therapeutic upper endoscopy including endoscopic combination therapy.
- Composite Endpoint [ Time Frame: Meassured after a week from primary therapeutic endoscopy ]
Patients are classified into groups depending on the worst outcome:
- No clinical signs of rebleeding and requirement of two or less blood transfusions after circulatory stabilization and obtained hemoglobin > 5,9mmol/L.
- No clinical signs of rebleeding and requirement of more than two blood transfusions after circulatory stabilization and obtained hemoglobin > 5,9mmol/L.
- Rebleeding and achieved secondary haemostasis by endoscopy or angiographic embolization.
- Rebleeding requiring surgery.
- Patients who have died.
Results are compared using the Wilcoxon rank sum test.
- Mortality [ Time Frame: 1 month ]Patients who have died within af month from therapeutic endoscopy.
- Rebleeding [ Time Frame: 1 month ]Rebleeding from ulcer confirmed by endoscopy, angiography or surgery within a month from therapeutic endoscopy.
- Blood transfusion [ Time Frame: 1 month ]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
- Surgical haemostasis [ Time Frame: 1 month ]Rebleeding requiring surgical haemostasis within a month from therapeutic endoscopy.
- Endoscopic/other haemostatic retreatment [ Time Frame: 1 month ]Rebleeding confirmed by endoscopy or angiography and achieved secondary haemostasis by endoscopy or angiographic embolization.
- Duration of hospitalization [ Time Frame: Estimated 4 days ]Time from hospitalization to discharge.
- Thromboembolic complications [ Time Frame: 1 month ]Occurence of thromboembolic complications due to angiographic embolization, surgery or therapeutic endoscopy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125852
|Odense University Hospital|