Contrast-Enhanced Harmonic Endoscopic Ultrasound Imaging - A Patient Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: 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.
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.
时间窗: 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.
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.
时间窗: 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.
次要结局
未报告次要终点