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

NCT04116970 | Active Not Recruiting DMC

• 2 other identifiers: OSU-18164NCI-2018-02965
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Diagnostic (bronchoscopy with EBUS-TBNA with/without vacuum)

EXPERIMENTAL

Patients undergo bronchoscopy with EBUS-TBUA first without and then with applied vacuum.

Procedure: Bronchoscopy; Procedure: Ultrasound-Guided Transbronchial Needle Aspiration

Interventions

Bronchoscopy PROCEDURE

Undergo bronchoscopy with EBUS-TBNA

Diagnostic (bronchoscopy with EBUS-TBNA with/without vacuum)

Ultrasound-Guided Transbronchial Needle Aspiration PROCEDURE

Undergo bronchoscopy with EBUS-TBNA

Also known as: EBUS-TBNA, Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration

Diagnostic (bronchoscopy with EBUS-TBNA with/without vacuum)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Computed tomography (CT)-scan finding suspicious for lung cancer with nodal metastases
• Clinically stable to undergo diagnostic workup by bronchoscopy with endobronchial ultrasound

You may not qualify if:

• Pregnant female
• Minors
• Prisoners
• Patients with contraindication for EBUS such as non-reversible anticoagulation

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Peter Kneuertz, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: October 7, 2019
• Study Start: August 31, 2020
• Primary Completion: April 17, 2023
• Study Completion (Estimated): June 15, 2026
• Last Updated: February 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)