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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-11067 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (medical records) | Patients who have undergo contrast-enhanced harmonic endoscopic ultrasound imaging have their medical records reviewed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Health Record Review | Other | Review of medical records |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who undergo contrast-enhanced harmonic endoscopic ultrasound imaging in the gastroenterology department at Mayo Clinic Jacksonville, Florida
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| Name | Affiliation | Role |
|---|---|---|
| Michael B Wallace | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | United States |
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