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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Carcinoma
• Intervention / Treatment: Procedure: Bronchoscopy; Procedure: Ultrasound-Guided Transbronchial Needle Aspiration

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 Type: Interventional
• Enrollment (Anticipated): 263
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Comprehensive Cancer Center
      • Contact: Peter J. Kneuertz, MD; Phone Number: 614-685-9922; Email: Peter.Kneuertz@osumc.edu
      • Principal Investigator: Peter J. Kneuertz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Peter Kneuertz, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 31, 2020
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: October 2, 2019
• First Posted (ACTUAL): October 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: OSU-18164; NCI-2018-02965 (REGISTRY: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No