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Completed

NCT Number: NCT05717101

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

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.

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Key information

Conditions

Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic Health Record Review

Other

Review of medical records

Primary outcomes

  1. 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.

    Time frame: Up to 5 years

    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.

  2. 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.

    Time frame: Up to 5 years

    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.

  3. 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.

    Time frame: Up to 5 years

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Contrast-Enhanced Harmonic Endoscopic Ultrasound Imaging - a Patient Registry

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 8, 2023
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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