Clinical trial NCT02508883: Evaluation of Prognostic Scores in Patients With Upper Gastrointestinal Bleeding and Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Gastrointestinal Bleeding
Keywords: Cancer
hemorrhage
endoscopy
gastrointestinal hemorrhage
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2015-07-27
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: blood transfusions administered
timeFrame: 30 days
measure: Endoscopic therapy
timeFrame: 30 days
measure: Surgery
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 30 days
measure: rebleeding
timeFrame: 30 days
measure: mortality
timeFrame: 30 days
Secondary outcomes:
measure: Finding the cut-off value of highest sensitivity and specificity of Rockall, Glasgow-Blatchford and AIMS65 scores employing the receiver operating curve (ROC).
timeFrame: 1 year
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Cancer Institute of São Paulo
Study officials:
affiliation: Cancer Institute of São Paulo
name: Fauze Maluf-Filho, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: