Patient Registry in Patients Undergoing Contrast-Enhanced Harmonic Endoscopic Ultrasound Imaging

Mayo Clinic4 enrolled

Overview

This study creates a patient registry of patients undergoing contrast-enhances-harmonic endoscopic ultrasound imaging. In order to improve what doctors see on the ultrasound exam, sometimes intravenous contrast can be used to better emphasize the blood flow in a particular organ or lesion. Creating a local database that can be used as a patients registry may help doctors keep track of all patients that undergo contrast-enhanced endoscopic ultrasound procedures and also to monitor for possible procedure adverse events.

PRIMARY OBJECTIVE: I. To describe the findings and outcomes of patient undergoing contrast-enhanced harmonic endoscopic ultrasound (CE-EUS) imaging. OUTLINE: This is an observational study. Patients who have undergo contrast-enhanced harmonic endoscopic ultrasound imaging have their medical records reviewed.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm

Interventions

Electronic Health Record Review

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female patients aged 18 years to 99 years old who were undergo CE-EUS are eligible for study inclusion * Based on clinical judgement of the advanced endoscopist will include those who present with lesions where increased microvasculature and perfusion visualization with contrast-enhanced harmonic endoscopic ultrasound imaging would be of beneficial for lesion characterization * Clinical medical stability to undergo sedation for endoscopy and provide informed consent Exclusion Criteria: * Medical condition that preclude the patient from having an endoscopic procedure * Patients who cannot provide adequate research authorization * Patients with known allergies to ultrasound contrast agents * Patient who did not receive contrast during endoscopic ultrasound (EUS) exams

Outcomes

Primary Outcomes

Analyse continuous variable outcomes of patient undergoing contrast-enhanced harmonic endoscopic ultrasound imaging using medical record review and T-tests or Mann-Whitney U test.

Descriptive statistical analysis will be carried out at routine intervals for database analysis. Two-sided P values less than 0.05 will be considered statistically significant. For descriptive analyses, continuous variables will be reported as a mean +/- standard deviation or median (interquartile range) and compared based on either T-tests or Mann-Whitney U test.

Time frame: Up to 5 years

Analyse categorical variable outcomes of patient undergoing contrast-enhanced harmonic endoscopic ultrasound imaging using medical record review and chi-square test or Fisher's exact test.

Descriptive statistical analysis will be carried out at routine intervals for database analysis. Two-sided P values less than 0.05 will be considered statistically significant. Categorical variables will be reported as frequencies with percentages and compared using the chi-square test or Fisher's exact test.

Time frame: Up to 5 years

Analyse multivariables of patient undergoing contrast-enhanced harmonic endoscopic ultrasound imaging using medical record review and logistic regression or linear regression analyses depending on the outcome.

Descriptive statistical analysis will be carried out at routine intervals for database analysis. Two-sided P values less than 0.05 will be considered statistically significant. Multivariable analyses will be performed using logistic regression or linear regression analyses depending on the outcome, i.e. dichotomous or continuous respectively.

Time frame: Up to 5 years

Patient Registry in Patients Undergoing Contrast-Enhanced Harmonic Endoscopic Ultrasound Imaging

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes