Endobronchial Ultrasound-Guided Transbronchial Needle-Aspiration With Suction in Obtaining Samples From Patients With Suspected Nodal Metastatic Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Trial to Analyze Endobronchial Ultrasound-Guided Transbronchial Needle-Aspiration (EBUS-TBNA) Samples Obtained With and Without Suction

Conditions
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Lung Carcinoma

Intervention / Treatment
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* Procedure: Bronchoscopy
* Procedure: Ultrasound-Guided Transbronchial Needle Aspiration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Computed tomography (CT)-scan finding suspicious for lung cancer with nodal metastases Clinically stable to undergo diagnostic workup by bronchoscopy with endobronchial ultrasound Exclusion Criteria: Pregnant female Minors Prisoners Patients with contraindication for EBUS such as non-reversible anticoagulation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (bronchoscopy with EBUS-TBNA with/without vacuum)<br>Patients undergo bronchoscopy with EBUS-TBUA first without and then with applied vacuum. | Procedure: Bronchoscopy<br>* Undergo bronchoscopy with EBUS-TBNA<br>Procedure: Ultrasound-Guided Transbronchial Needle Aspiration<br>* Undergo bronchoscopy with EBUS-TBNA<br>* Other names: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of samples collected via endobronchial ultrasound-guided transbronchial needle-aspiration with suction | 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. | Up to 3 years |