Malignant Neoplasm of Respiratory and Intrathoracic Organ CarcinomaNCT03004586
Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration Using a 22 vs 25-Gauge Needle
A study testing 25-Gauge Needle, 22-Gauge Needle and Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA) in people with Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma and Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to compare the effectiveness of a smaller, 25-gauge needle when used in an endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) instead of a standard 22-gauge needle. The safety of the needles will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma, Lung Cancer
- What is being tested?
- 25-Gauge Needle, 22-Gauge Needle and Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2016to 25 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 years or older
- Indication for EBUS-guided needle biopsy based on suspicion of either benign or malignant disease in mediastinal or hilar lymph nodes.
Who cannot join
- Patients who are pregnant or lactating
- Inability to give informed consent
- Patients in which only one lymph node station is expected to be sampled by the performing clinician.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Endobronchial Ultrasound-guided Transbronchial Needle Aspiration Using a 22 vs 25-Gauge Needle; A Randomized Controlled Trial
The goal of this clinical research study is to compare the effectiveness of a smaller, 25-gauge needle when used in an endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) instead of a standard 22-gauge needle.
The safety of the needles will also be studied.
Read the detailed description
As a part of participant's standard-of-care, participant will have a bronchoscopy of lesions on participant's lung nodules and/or lymph nodes before the EBUS-TBNA. Participant will sign a separate consent for the bronchoscopy.
If participant agrees to take part in this study, before participant's bronchoscopy, participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.
- If participant is in Group 1, participant will have the EBUS-TBNA performed by first using a 25-gauge needle, followed by a 22-gauge needle.
- If participant is in Group 2, participant will have the EBUS-TBNA performed by first using a 22-gauge needle, followed by a 25-gauge needle.
To perform an EBUS-TBNA, a needle is inserted into the affected area using ultrasound imaging to collect tissue from the lungs and lymph nodes. The doctor will use the imaging to guide the needle into the area.
Length of Study:
Participation on the study will be over after the bronchoscopy and EBUS-TBNA.
This is an investigational study. The 22-gauge and 25-gauge needles are FDA approved for use in EBUS-TBNAs. The comparison of the 2 needles for this procedure is investigational. The study doctor can explain how the needles are designed to work.
Up to 120 participants will be enrolled in this study. All will take part at MD Anderson.
- Being tested
- 25-Gauge Needle, 22-Gauge Needle, Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA)
- Keywords
- Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma, Lung cancer, Ultrasound-guided transbronchial needle aspiration, EBUS-TBNA, 25-gauge needle, 22-gauge needle
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25-Gauge NeedleDevice
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle.
22-Gauge NeedleDevice
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle.
Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA)Procedure or surgery
Also called EBUS-TBNA
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed.
| Study group | Role | What they receive |
|---|---|---|
| EBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle | Experimental | Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 25-gauge needle, followed by a 22-gauge needle. Receives: Device: 25-Gauge Needle; Device: 22-Gauge Needle; Procedure: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA) |
| EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge Needle | Experimental | Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 22-gauge needle, followed by a 25-gauge needle. Receives: Device: 25-Gauge Needle; Device: 22-Gauge Needle; Procedure: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Lymph Nodes With Adequate Samples
The primary outcome was the proportion of concordance between the 22-gauge and 25-gauge needles in sample adequacy after two passes. The intervention group each of the lymph nodes sampled first with 25 gauge-needle, then the 22 gauge-needle. The Control Group each of the 200 lymph nodes were sampled first with the 22 gauge- needles, then the 25 gauge-needle. Sample adequacy was assessed after 2 passes using each needle in all participants and recorded.
Measured: One to two hours.
Secondary outcomes (2)
Concordance With the Final Diagnosis
The difference in the diagnostic yield between the 22-gauge and 25-gauge needles in terms of degree of concordance with the final diagnosis. The intervention group each of the lymph nodes sampled first with 25 gauge-needle, then the 22 gauge-needle. The Control Group each of the 200 lymph nodes were sampled first with the 22 gauge- needles, then the 25 gauge-needle. The percentage of concordance was calculated by comparing the 2 passes from each needle to the final diagnosis.
Measured: One to two hours
Usability of the Needle
The difference in usability between the 22-gauge and 25-gauge needles. All participant's lymph nodes were sampled by two 25-gauge needles and two 22-gauge needles for a total of 4 needles per person. Measured by a Likert scale 1-5 with 1 being the lowest and 5 being the maximum score. The intervention group each of the lymph nodes sampled first with 25 gauge-needle, then the 22 gauge-needle. The Control Group each of the 200 lymph nodes were sampled first with the 22 gauge- needles, then the 25 gauge-needle. The participants are reported per intervention.
Measured: 1-2 hours (Intra procedurally)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study start16 Dec 2016
- Primary completion25 Jun 2020
- Study completion25 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant Neoplasm of Respiratory and Intrathoracic Organ CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- George A. Eapen, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004586
- Sponsor's protocol ID
- 2016-0561
- Other IDs
- NCI-2017-00624
- Status last verified
- May 2022
- First submitted
- 19 Dec 2016
- Last updated
- 22 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endobronchial Ultrasound-guided Transbronchial Needle Aspiration Using a 22 vs 25-Gauge Needle; A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03004586
- Acronym / sponsor ID
- 2016-0561
- Keywords
- Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma, Lung cancer, Ultrasound-guided transbronchial needle aspiration, EBUS-TBNA, 25-gauge needle, 22-gauge needle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 16 Dec 2016 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Posted 22 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to compare the effectiveness of a smaller, 25-gauge needle when used in an endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) instead of a standard 22-gauge needle.
The safety of the needles will also be studied.
Detailed description
As a part of participant's standard-of-care, participant will have a bronchoscopy of lesions on participant's lung nodules and/or lymph nodes before the EBUS-TBNA. Participant will sign a separate consent for the bronchoscopy.
If participant agrees to take part in this study, before participant's bronchoscopy, participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.
- If participant is in Group 1, participant will have the EBUS-TBNA performed by first using a 25-gauge needle, followed by a 22-gauge needle.
- If participant is in Group 2, participant will have the EBUS-TBNA performed by first using a 22-gauge needle, followed by a 25-gauge needle.
To perform an EBUS-TBNA, a needle is inserted into the affected area using ultrasound imaging to collect tissue from the lungs and lymph nodes. The doctor will use the imaging to guide the needle into the area.
Length of Study:
Participation on the study will be over after the bronchoscopy and EBUS-TBNA.
This is an investigational study. The 22-gauge and 25-gauge needles are FDA approved for use in EBUS-TBNAs. The comparison of the 2 needles for this procedure is investigational. The study doctor can explain how the needles are designed to work.
Up to 120 participants will be enrolled in this study. All will take part at MD Anderson.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle | Experimental | Device: 25-Gauge Needle, Device: 22-Gauge Needle, Procedure: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA)Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 25-gauge needle, followed by a 22-gauge needle. |
| EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge Needle | Experimental | Device: 25-Gauge Needle, Device: 22-Gauge Needle, Procedure: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA)Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 22-gauge needle, followed by a 25-gauge needle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years or older
- Indication for EBUS-guided needle biopsy based on suspicion of either benign or malignant disease in mediastinal or hilar lymph nodes.
Key exclusion criteria (3 listed)
- Patients who are pregnant or lactating
- Inability to give informed consent
- Patients in which only one lymph node station is expected to be sampled by the performing clinician.
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 |
|---|---|---|
| 25-Gauge NeedleEndobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle. | Device | EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge Needle, EBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle |
| 22-Gauge NeedleEndobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle. | Device | EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge Needle, EBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle |
| Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA)Also: EBUS-TBNAEndobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed. | Procedure or surgery | EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge Needle, EBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle |
Primary outcome
Percentage of Lymph Nodes With Adequate Samples
Time frame: One to two hours.
The primary outcome was the proportion of concordance between the 22-gauge and 25-gauge needles in sample adequacy after two passes. The intervention group each of the lymph nodes sampled first with 25 gauge-needle, then the 22 gauge-needle. The Control Group each of the 200 lymph nodes were sampled first with the 22 gauge- needles, then the 25 gauge-needle. Sample adequacy was assessed after 2 passes using each needle in all participants and recorded.
2 secondary outcomes
Concordance With the Final Diagnosis
Time frame: One to two hours
Usability of the Needle
Time frame: 1-2 hours (Intra procedurally)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
George A. Eapen, MD principal investigator
M.D. Anderson 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 25-Gauge Needle, 22-Gauge Needle and Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA) in people with Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma and Lung Cancer, run by M.D. Anderson 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 3 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 22 Jun 2022. 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?
Yes. Results are posted in the registry (first posted 22 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Lymph Nodes With Adequate Samples (time frame: One to two hours.). 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 22 Jun 2022.