Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Active Comparator | 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. |
|
| Control group | Active Comparator | Patients in this arm receive standard treatment including therapeutic endoscopy with endoscopic combination therapy followed by 72 hours intravenous proton pump inhibitor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angiographic embolization | Procedure | Patients in the intervention arm receive supplementary angiographic embolization within 24 hours from the therapeutic endoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite Endpoint | Patients are classified into groups depending on the worst outcome:
Results are compared using the Wilcoxon rank sum test. | Meassured after a week from primary therapeutic endoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Patients who have died within af month from therapeutic endoscopy. | 1 month |
| Rebleeding | Rebleeding from ulcer confirmed by endoscopy, angiography or surgery within a month from therapeutic endoscopy. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24256098 | Derived | Laursen SB, Hansen JM, Andersen PE, Schaffalitzky de Muckadell OB. Supplementary arteriel embolization an option in high-risk ulcer bleeding--a randomized study. Scand J Gastroenterol. 2014 Jan;49(1):75-83. doi: 10.3109/00365521.2013.854829. Epub 2013 Nov 21. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010438 | Peptic Ulcer Hemorrhage |
| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
Not provided
Not provided
| ID | Term |
|---|---|
| D004621 | Embolization, Therapeutic |
| ID | Term |
|---|---|
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Therapeutic endoscopy | Procedure | Patients are treated with standard therapeutic upper endoscopy including endoscopic combination therapy. |
|
| 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 | 1 month |
| Surgical haemostasis | Rebleeding requiring surgical haemostasis within a month from therapeutic endoscopy. | 1 month |
| Endoscopic/other haemostatic retreatment | Rebleeding confirmed by endoscopy or angiography and achieved secondary haemostasis by endoscopy or angiographic embolization. | 1 month |
| Duration of hospitalization | Time from hospitalization to discharge. | Estimated 4 days |
| Thromboembolic complications | Occurence of thromboembolic complications due to angiographic embolization, surgery or therapeutic endoscopy. | 1 month |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |