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This is a prospective and observational study to evaluate oncologic patients that presented upper gastrointestinal bleeding with the use of some prognostic scores.
Background: Cancer incidence is rising worldwide, therefore complications of this condition, such as bleeding, are also expected to be more frequently seen.
Tumoral bleeding is usually difficult to control and the bleeding episode may represent the end stage of the malignant disease. In this context, it is relevant to study the performance of prognostic scores to prediction of clinical outcomes in patients with cancer.
Objective: To evaluate and compare the performance of prognostic scores to predict clinical outcomes in a group of patients with cancer of any site that has presented a recent episode of upper gastrointestinal bleeding (UGIB).
Design: Prospective and observational study. Setting: Cancer Institute of São Paulo; University of são Paulo. Patients: All patients with cancer referred to the Endoscopy Unit because of upper gastrointestinal bleeding will be included consecutively.
Main Outcome Measurements: need and amount of blood transfusions administered, need for endoscopic therapy, surgery, rebleeding, and mortality at 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upper gastrointestinal bleeding | patients with cancer who presented or were admitted in the emergency room, wards or intensive care units of the Cancer Institute of São Paulo (ICESP), with a recent episode of upper gastrointestinal bleeding. |
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| Measure | Description | Time Frame |
|---|---|---|
| blood transfusions administered | The need and amount of blood transfusions administered | 30 days |
| Endoscopic therapy | Hemostatic endoscopic therapy will be performed if there are findings of active or recent bleeding, under conscious or deep sedation after hemodynamic stabilization and oral fasting | 30 days |
| Surgery | need for surgery to control tumour bleeding | participants will be followed for the duration of hospital stay, an expected average of 30 days |
| rebleeding | episodes of rebleeding | 30 days |
| mortality | mortality | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Finding the cut-off value of highest sensitivity and specificity of Rockall, Glasgow-Blatchford and AIMS65 scores employing the receiver operating curve (ROC). | find the cut-off value of highest sensitivity and specificity of Rockall, Glasgow-Blatchford and AIMS65 scores for discriminant selection of a low-risk group, if one exists, among patients with recent upper gastrointestinal bleeding and cancer with confirmed diagnosis, located inside or outside the GI tract, who could be managed on an outpatient basis. |
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Inclusion Criteria:
Exclusion Criteria:
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All patients referred to the Endoscopy Unit of ICESP because of upper gastrointestinal bleeding will be included consecutively, according to the selection criteria mentioned below.
The analysis of our recent data base allows us to estimate an accrual of about 300 patients at the end of 1 year of study.
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| Name | Affiliation | Role |
|---|---|---|
| Fauze Maluf-Filho, MD, PHD | Cancer Institute of São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute of São Paulo | São Paulo | São Paulo | 01246-000 | Brazil |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D009369 | Neoplasms |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 1 year |