Hemostatic Powder Versus Clinical Management for the Treatment of Upper Gastrointestinal Bleeding From Tumor Lesions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Controlled Trial of Hemostatic Powder Versus Optimal Clinical Management for the Treatment of Upper Gastrointestinal Bleeding From Tumor Lesions

Conditions
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Gastrointestinal Hemorrhage, Gastrointestinal Neoplasms

Intervention / Treatment
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* Device: Hemospray (Endoscopic treatment with hemostatic powder)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any kind of malignancy Gastrointestinal bleeding in the last 48 hours Referred to emergency endoscopy Exclusion Criteria: under 18 years old bleeding from non malignant lesions previous endoscopic treatment with another method done in the last 48h

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemospray<br>Patients treated with hemostatic powder | Device: Hemospray (Endoscopic treatment with hemostatic powder)<br>* Malignant bleeding lesions will be treated with endoscopic powder and patients will receive optical clinical management afterwards<br>|
| No Intervention: Clinical support<br>Patients treated with optimal clinical management, as it is been advised by the latest guidelines | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rebleeding |  | until 30 days after endoscopy | 
| mortality |  | until 30 days after endoscopy | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopy, Gastrointestinal