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

Comparison Among the Scores of Glasgow-Blacthford, Rockall and AIMS65 for the Prediction of Rebleeding and Mortality in Patients With Cancer and Upper Gastrointestinal Bleeding

This is a prospective and observational study to evaluate oncologic patients that presented upper gastrointestinal bleeding with the use of some prognostic scores.

Study Overview

• Status: Completed
• Conditions: Upper Gastrointestinal Bleeding

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.

• Study Type: Observational
• Enrollment (Actual): 243

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01246-000
    • Cancer Institute of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	mortality	30 days
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

Secondary Outcome Measures

Outcome Measure	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.	1 year

Collaborators and Investigators

• Sponsor: Instituto do Cancer do Estado de São Paulo
• Investigators: Principal Investigator: Fauze Maluf-Filho, MD, PHD, Cancer Institute of São Paulo

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: May 29, 2015
• First Submitted That Met QC Criteria: July 23, 2015
• First Posted (Estimate): July 27, 2015

Study Record Updates

• Last Update Posted (Estimate): October 6, 2016
• Last Update Submitted That Met QC Criteria: October 5, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Cancer; hemorrhage; endoscopy; gastrointestinal hemorrhage
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: NP621/14