Upper Gastrointestinal Bleeding
Conditions
Keywords
Cancer, hemorrhage, endoscopy, gastrointestinal hemorrhage
Brief summary
This is a prospective and observational study to evaluate oncologic patients that presented upper gastrointestinal bleeding with the use of some prognostic scores.
Detailed description
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.
Interventions
None listed
Sponsors
Instituto do Cancer do Estado de São Paulo
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of malignant neoplasm of any site, either located inside or outside of GI tract; * Current evidence of bleeding in the last 48 hours, either by presenting hematemesis and/or melena, with or without hemodynamic instability. Patients with hematochezia or bright red blood per rectum due to a site of bleeding in upper GI tract will also be included.
Exclusion criteria
* Age \< 18 years-old; * Suspicion or confirmation of pregnancy. * Patients with no evidence of malignant neoplasm after curative surgery or oncologic therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| blood transfusions administered | 30 days | The need and amount of blood transfusions administered |
| Endoscopic therapy | 30 days | 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 |
| Surgery | participants will be followed for the duration of hospital stay, an expected average of 30 days | need for surgery to control tumour bleeding |
| rebleeding | 30 days | episodes of rebleeding |
| mortality | 30 days | mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Finding the cut-off value of highest sensitivity and specificity of Rockall, Glasgow-Blatchford and AIMS65 scores employing the receiver operating curve (ROC). | 1 year | 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. |
Countries
Brazil
Outcome results
None listed