Lung CarcinomaEBUS-SuctionNCT04116970
Endobronchial Ultrasound-Guided Transbronchial Needle-Aspiration With Suction in Obtaining Samples From Patients With Suspected Nodal Metastatic Lung Cancer
A study testing Bronchoscopy and Ultrasound-Guided Transbronchial Needle Aspiration in people with Lung Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Carcinoma
- What is being tested?
- Bronchoscopy and Ultrasound-Guided Transbronchial Needle Aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2020to 4 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Computed tomography (CT)-scan finding suspicious for lung cancer with nodal metastases
- Clinically stable to undergo diagnostic workup by bronchoscopy with endobronchial ultrasound
Who cannot join
- Pregnant female
- Minors
- Prisoners
- Patients with contraindication for EBUS such as non-reversible anticoagulation
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Lung Carcinoma
- Being tested
- Bronchoscopy, Ultrasound-Guided Transbronchial Needle Aspiration
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyProcedure or surgery
Undergo bronchoscopy with EBUS-TBNA
Ultrasound-Guided Transbronchial Needle AspirationProcedure or surgery
Also called EBUS-TBNA, Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration
Undergo bronchoscopy with EBUS-TBNA
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (bronchoscopy with EBUS-TBNA with/without vacuum) | Experimental | Patients undergo bronchoscopy with EBUS-TBUA first without and then with applied vacuum. Receives: Procedure: Bronchoscopy; Procedure: Ultrasound-Guided Transbronchial Needle Aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start31 Aug 2020
- Primary completion17 Apr 2023
- Study completion4 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Kneuertz, Ohio State University Comprehensive Cancer Center
- Investigators
- Peter Kneuertz, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116970
- Sponsor's protocol ID
- OSU-18164
- Other IDs
- NCI-2018-02965
- Acronym
- EBUS-Suction
- Status last verified
- Jun 2026
- First submitted
- 9 Jan 2019
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial to Analyze Endobronchial Ultrasound-Guided Transbronchial Needle-Aspiration (EBUS-TBNA) Samples Obtained With and Without Suction
- ClinicalTrials.gov ID
- NCT04116970
- Acronym / sponsor ID
- EBUS-Suction / OSU-18164
- Conditions
- Lung Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 7 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (bronchoscopy with EBUS-TBNA with/without vacuum) | Experimental | Procedure: Bronchoscopy, Procedure: Ultrasound-Guided Transbronchial Needle AspirationPatients undergo bronchoscopy with EBUS-TBUA first without and then with applied vacuum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Computed tomography (CT)-scan finding suspicious for lung cancer with nodal metastases
- Clinically stable to undergo diagnostic workup by bronchoscopy with endobronchial ultrasound
Key exclusion criteria (4 listed)
- Pregnant female
- Minors
- Prisoners
- Patients with contraindication for EBUS such as non-reversible anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BronchoscopyUndergo bronchoscopy with EBUS-TBNA | Procedure or surgery | Diagnostic (bronchoscopy with EBUS-TBNA with/without vacuum) |
| Ultrasound-Guided Transbronchial Needle AspirationAlso: EBUS-TBNA, Endobronchial Ultrasound-Guided Transbronchial Needle AspirationUndergo bronchoscopy with EBUS-TBNA | Procedure or surgery | Diagnostic (bronchoscopy with EBUS-TBNA with/without vacuum) |
Primary outcome
Number of samples collected via endobronchial ultrasound-guided transbronchial needle-aspiration with suction
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Kneuertz, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopy and Ultrasound-Guided Transbronchial Needle Aspiration in people with Lung Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of samples collected via endobronchial ultrasound-guided transbronchial needle-aspiration with suction (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.