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

Not Applicable

Active, not recruiting

• Conditions: Lung Carcinoma
• Interventions: Procedure: Bronchoscopy; Procedure: Ultrasound-Guided Transbronchial Needle Aspiration

• Registration Number: NCT04116970
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-10-02
• Study First Posted: 2019-10-07
• Study Start: 2020-08-31
• Primary Completion: 2025-03-26
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (bronchoscopy with EBUS-TBNA with/without vacuum)	Bronchoscopy	Patients undergo bronchoscopy with EBUS-TBUA first without and then with applied vacuum.
Diagnostic (bronchoscopy with EBUS-TBNA with/without vacuum)	Ultrasound-Guided Transbronchial Needle Aspiration	Patients undergo bronchoscopy with EBUS-TBUA first without and then with applied vacuum.

Primary Outcome Measures

Name	Time	Method
Number of samples collected via endobronchial ultrasound-guided transbronchial needle-aspiration with suction	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.

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States