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

N/AActive Not RecruitingNCT04116970

Ohio State University Comprehensive Cancer Center50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Lung Carcinoma

Interventions

BronchoscopyPROCEDURE

Undergo bronchoscopy with EBUS-TBNA

Ultrasound-Guided Transbronchial Needle AspirationPROCEDURE

Undergo bronchoscopy with EBUS-TBNA

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 3 years

Data from ClinicalTrials.gov

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