Evaluation of Prognostic Scores in Patients With Upper Gastrointestinal Bleeding and Cancer

NCT ID: NCT02508883

Last Updated: 2016-10-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 243 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-06-30

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.

Conditions

Upper Gastrointestinal Bleeding

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fauze Maluf-Filho, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute of São Paulo

Locations

Cancer Institute of São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

NP621/14

Identifier Type: -

Identifier Source: org_study_id