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

NCT05717101 | Completed

• 2 other identifiers: 18-008737NCI-2022-11067
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Observational (medical records)

Patients who have undergo contrast-enhanced harmonic endoscopic ultrasound imaging have their medical records reviewed.

Other: Electronic Health Record Review

Interventions

Electronic Health Record Review OTHER

Review of medical records

Observational (medical records)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who undergo contrast-enhanced harmonic endoscopic ultrasound imaging in the gastroenterology department at Mayo Clinic Jacksonville, Florida

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Study Officials

• Michael B Wallace

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: February 8, 2023
• Study Start: December 17, 2018
• Primary Completion: October 29, 2020
• Study Completion: October 29, 2020
• Last Updated: September 24, 2024

Record last verified: 2023-01

Locations

US (1)