Prospective Trial to Analyze Endobronchial Ultrasound-Guided Transbronchial Needle-Aspiration (EBUS-TBNA) Samples Obtained With and Without Suction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of samples collected via endobronchial ultrasound-guided transbronchial needle-aspiration with suction
研究概览
简要总结
This trial studies how well endobronchial ultrasound-guided transbronchial needle-aspiration (EBUS-TBNA) with suction works in obtaining samples from patients with suspected lung cancer that has spread to the nodal. EBUS-TBNA samples obtained with additional suction may help to improve material-amounts and decrease blood contamination in the samples.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate if suction applied with a vacuum syringe during EBUS-TBNA sampling helps to obtain more material for molecular analyses.
OUTLINE:
Patients undergo bronchoscopy with EBUS-TBUA first without and then with applied vacuum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Computed tomography (CT)-scan finding suspicious for lung cancer with nodal metastases
- •Clinically stable to undergo diagnostic workup by bronchoscopy with endobronchial ultrasound
排除标准
- •Pregnant female
- •Prisoners
- •Patients with contraindication for EBUS such as non-reversible anticoagulation
研究组 & 干预措施
Diagnostic (bronchoscopy with EBUS-TBNA with/without vacuum)
Patients undergo bronchoscopy with EBUS-TBUA first without and then with applied vacuum.
干预措施: Bronchoscopy (Procedure)
Diagnostic (bronchoscopy with EBUS-TBNA with/without vacuum)
Patients undergo bronchoscopy with EBUS-TBUA first without and then with applied vacuum.
干预措施: Ultrasound-Guided Transbronchial Needle Aspiration (Procedure)
结局指标
主要结局
Number of samples collected via endobronchial ultrasound-guided transbronchial needle-aspiration with suction
时间窗: Up to 3 years
The qualitative data will have a set number of variable to follow and will be converted to quantitative data. Data will be analyzed using Microsoft Excel, SAS, or SPSS. After checking the normality of the data, all non-parametric data will be converted to parametric data. Appropriate tests for categorical and continuous data will be used. Categorical variables will be compared using Chi-square or Fisher?s Exact test. Normally distributed variables will be compared using Student-T-test and one way analysis of variance. Non-parametric test will include Mann Whitney U test and Kruskal Wallis test. A two tailed p value of \< 0.05 will be considered significant.Sample weight (microgram) and visual blood contamination score (0 = no visible blood, 1 = light red shading, 2 = red shading) of endobronchial needle aspiration biopsies obtained with and without suction.
次要结局
未报告次要终点
研究者
Peter Kneuertz
Principal Investigator
Ohio State University Comprehensive Cancer Center