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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT05717101
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Actual Duration (Months): 22.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm	Other: Electronic Health Record Review

Detailed Description

PRIMARY OBJECTIVE:

1. 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 Design

• Study Type: Observational
• Actual Enrollment: 4 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Contrast-Enhanced Harmonic Endoscopic Ultrasound Imaging - A Patient Registry
• Actual Study Start Date: Dec 17, 2018
• Actual Primary Completion Date: Oct 29, 2020
• Actual Study Completion Date: Oct 29, 2020

Arms and Interventions

Arm	Intervention/Treatment
Observational (medical records) Patients who have undergo contrast-enhanced harmonic endoscopic ultrasound imaging have their medical records reviewed.	Other: Electronic Health Record Review; Review of medical records

Outcome Measures

Primary Outcome Measures

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. [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. [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. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Florida	Jacksonville	Florida	United States	32224-9980

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Michael B Wallace, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mayo Clinic
• ClinicalTrials.gov Identifier: NCT05717101
• Other Study ID Numbers: 18-008737; NCI-2022-11067
• First Posted: Feb 8, 2023
• Last Update Posted: Feb 8, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Feb 8, 2023