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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
| Erasme University Hospital | OTHER |
| King Chulalongkorn Memorial Hospital | OTHER |
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The aim of the study is to compare the outcomes of trans-catheter arterial embolization (TAE) and surgery as salvage therapy of peptic ulcer bleeding after failed endoscopic therapy.
The aim of the study is to examine the hypothesis that trans-catheter arterial embolization (TAE) is safer than and probably as effective as surgery in the control of bleeding from ulcers after failed endoscopic therapy. Patients with major arterial bleeding that cannot be stopped by endoscopic therapy will be randomly assigned to receive immediate TAE or surgery. Primary outcome will be death within 30 days of randomization. Secondary outcomes include recurrent bleeding after assigned treatment, need for additional intervention either in the form of interventional radiology or surgery, and post procedural morbidities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAE group | Active Comparator | Trans-catheter arterial embolization |
|
| Surgery group | Active Comparator | Surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trans-catheter arterial embolization | Procedure | Trans-catheter arterial embolization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality within 30 days of randomization | Mortality within 30 days of randomization | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent bleeding after assigned treatment | Recurrent bleeding after assigned treatment | 60 days |
| The need for additional intervention either in the form of interventional radiology | The need for additional intervention either in the form of interventional radiology |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James YW LAU, MD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endoscopy Center, Prince of Wales Hospital | Hong Kong | China |
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| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Surgery | Procedure | Surgery |
|
| 60 days |
| Post procedural morbidities | Post procedural morbidities | 60 days |
| The need for additional intervention either in the form of surgery | The need for additional intervention either in the form of surgery | 60 days |
| D013272 | Stomach Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |