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Global recall of Hemospray
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This study evaluates the efficacy of the endoscopic hemostatic powder for the treatment of bleeding from malignant lesions of the upper GI tract. Half of participants will receive hemostatic powder and half will be submitted to standard treatment.
Gastrointestinal tumor bleeding is a challenging clinical condition with a high mortality rate. Several endoscopic hemostasis techniques have been tested, but results were disappointing. Re-bleeding and mortality rates are still high.
Hemostatic powder is a promising therapy for tumor bleeding, since it can be applied over large surfaces. Bleeding from a tumor lesion often occurs diffusely on the surface of the tumor rather than from a specific vessel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemospray | Experimental | Patients treated with hemostatic powder |
|
| Clinical support | No Intervention | Patients treated with optimal clinical management, as it is been advised by the latest guidelines |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemospray (Endoscopic treatment with hemostatic powder) | Device | Malignant bleeding lesions will be treated with endoscopic powder and patients will receive optical clinical management afterwards |
| Measure | Description | Time Frame |
|---|---|---|
| rebleeding | until 30 days after endoscopy | |
| mortality | until 30 days after endoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Successful initial hemostasis | From the moment of the procedure until 24 hours after it | |
| Hospital length of stay | from the moment of the endoscopic procedure until hospital discharge or death, whichever came first, assessed up to 100 months |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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