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

Malignant Solid Neoplasm Clinical Trial

Official title:

Contrast-Enhanced Harmonic Endoscopic Ultrasound Imaging - A Patient Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05717101
• Other study ID #: 18-008737
• Secondary ID: NCI-2022-11067
• Status: Completed
• Start date: December 17, 2018
• Est. completion date: October 29, 2020

Study information

• Verified date: January 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: October 29, 2020
• Est. primary completion date: October 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid System Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Other:
• Electronic Health Record Review
Review of medical records

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 5 years
Primary	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.	Up to 5 years
Primary	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.	Up to 5 years