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

Upper Gastrointestinal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02508883
• Other study ID #: NP621/14
• Status: Completed
• Phase: N/A
• First received: May 29, 2015
• Last updated: October 5, 2016
• Start date: April 2015
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Upper Gastrointestinal Bleeding

Locations

Country	Name	City	State
Brazil	Cancer Institute of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood transfusions administered	The need and amount of blood transfusions administered	30 days	Yes
Primary	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	Yes
Primary	Surgery	need for surgery to control tumour bleeding	participants will be followed for the duration of hospital stay, an expected average of 30 days	Yes
Primary	rebleeding	episodes of rebleeding	30 days	Yes
Primary	mortality	mortality	30 days	Yes
Secondary	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	No