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

Primary Purpose

Lung Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bronchoscopy
Ultrasound-Guided Transbronchial Needle Aspiration
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio State University Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 9, 2019
Last Updated
June 13, 2022
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04116970
Brief Title
Endobronchial Ultrasound-Guided Transbronchial Needle-Aspiration With Suction in Obtaining Samples From Patients With Suspected Nodal Metastatic Lung Cancer
Official Title
Prospective Trial to Analyze Endobronchial Ultrasound-Guided Transbronchial Needle-Aspiration (EBUS-TBNA) Samples Obtained With and Without Suction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
263 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (bronchoscopy with EBUS-TBNA with/without vacuum)
Arm Type
Experimental
Arm Description
Patients undergo bronchoscopy with EBUS-TBUA first without and then with applied vacuum.
Intervention Type
Procedure
Intervention Name(s)
Bronchoscopy
Intervention Description
Undergo bronchoscopy with EBUS-TBNA
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-Guided Transbronchial Needle Aspiration
Other Intervention Name(s)
EBUS-TBNA, Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration
Intervention Description
Undergo bronchoscopy with EBUS-TBNA
Primary Outcome Measure Information:
Title
Number of samples collected via endobronchial ultrasound-guided transbronchial needle-aspiration with suction
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
The Ohio State University Comprehensive Cancer Center
Phone
1-800-293-5066
Email
OSUCCCClinicaltrials@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Kneuertz, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter J. Kneuertz, MD
Phone
614-685-9922
Email
Peter.Kneuertz@osumc.edu
First Name & Middle Initial & Last Name & Degree
Peter J. Kneuertz, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

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

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