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NCT04116970 Clinical Trial

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

Lung Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04116970
Other study ID # OSU-18164
Secondary ID NCI-2018-02965
Status Recruiting
Phase N/A
First received
Last updated
Start date August 31, 2020
Est. completion date December 31, 2022

Study information
Verified date June 2022
Source Ohio State University Comprehensive Cancer Center
Contact The Ohio State University Comprehensive Cancer Center
Phone 1-800-293-5066
Email OSUCCCClinicaltrials@osumc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 263
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Bronchoscopy
Undergo bronchoscopy with EBUS-TBNA
• Ultrasound-Guided Transbronchial Needle Aspiration
Undergo bronchoscopy with EBUS-TBNA

Locations
Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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