Lung CancerNCT01741571
Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques
A study testing EBUS guided FNA with and without suction in people with Lung Cancer, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TBNA) techniques have not been well studied. The investigators will conduct a randomized study comparing the diagnostic yield and specimen quality of EBUS-FNA performed with and without suction applied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- EBUS guided FNA with and without suction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteLebanon
- Study dates
- Dec 2012to Jan 2017
- 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
- Adult undergoing EBUS at AUBMC for suspected malignancy
Who cannot join
- Coagulopathy
- The lesion cannot be sampled because of intervening tumor or blood vessels.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques
Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TBNA) techniques have not been well studied. The investigators will conduct a randomized study comparing the diagnostic yield and specimen quality of EBUS-FNA performed with and without suction applied.
Read the detailed description
Consecutive patients with suspected malignant peribronchial masses or lymph nodes undergoing endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) will be enrolled. All participants will have 4 needle aspirations of each targeted peribronchial lesion. Two needle aspirations will be performed while applying suction and 2 needle aspirations will be performed without applying suction in random order. The investigators will compare the diagnostic yield and the quality of the specimens obtained using the two techniques.
- Conditions
- Lung Cancer
- Being tested
- EBUS guided FNA with and without suction
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBUS guided FNA with and without suctionDevice
Device/procedure: lymph node tissue collection using needle with and without suction applied.
Four fine needle aspirations will be taken from each lymph node. Two with suction and two without suction applied.
| Study group | Role | What they receive |
|---|---|---|
| EBUS guided FNA with suction | Active comparator | Device/procedure: lymph node tissue collection using fine needle aspiration with suction applied.
Four fine needle aspirations will be taken sequentially from each lymph node. Two with suction and two without suction applied. Receives: Device: EBUS guided FNA with and without suction |
| EBUS guided FNA without suction | Experimental | Device/procedure: lymph node tissue collection using fine needle aspiration without suction applied.
Four fine needle aspirations will be taken sequentially from each lymph node. Two with suction and two without suction applied. Receives: Device: EBUS guided FNA with and without suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of each needle aspiration technique for diagnosis of malignancy
A pathologist blinded to the needle aspiration technique will review the specimen obtained from each needle aspiration and will assess for presence of malignant cells.
The sensitivity for diagnosing malignancy will be calculated and compared for the two needle aspiration technique.
Measured: Diagnosis of malignancy will be ascertained after 6 month clinical follow up
Diagnostic accuracy of each needle aspiration technique for diagnosis of malignancy
A pathologist blinded to the needle aspiration technique will review the specimen obtained from each needle aspiration and will assess for presence of malignant cells.
The diagnostic accuracy for diagnosing malignancy will be assessed and compared for the two needle aspiration technique.
Measured: Diagnosis of malignancy will be ascertained after 6 month clinical follow up
Secondary outcomes (4)
Adequacy of the needle aspiration sample
A pathologist blinded to the needle aspiration technique will review the specimen obtained from each needle aspiration and will assess for adequacy (presence of malignant cells, granuloma or lymphocytes) The number of adequate samples will be compared for the two techniques.
Measured: Adequacy will be assessed within 1 week from procedure
Negative predicted value of each needle aspiration technique for diagnosis of malignancy
A pathologist blinded to the needle aspiration technique will review the specimen obtained from each needle aspiration and will assess for presence of malignant cells.
The negative predictive value for lack of malignant cells will be calculated and compared for the two needle aspiration techniques.
Measured: Diagnosis of malignancy will be ascertained after 6 month of clinical follow up
Specificity of each needle aspiration technique for diagnosis of malignancy
A pathologist blinded to the needle aspiration technique will review the specimen obtained from each needle aspiration and will assess for presence of malignant cells.
The specificity for diagnosing malignant cells will be calculated and compared for the two needle aspiration techniques.
Measured: Diagnosis of malignancy will be ascertained after 6 month clinical follow up
Positive predicted value of each needle aspiration technique for diagnosis of malignancy
A pathologist blinded to the needle aspiration technique will review the specimen obtained from each needle aspiration and will assess for presence of malignant cells.
The positive predictive value for presence of malignant cells will be calculated and compared for the two needle aspiration techniques.
Measured: Diagnosis of Malignancy will be ascertained after 6 month of clinical follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJan 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Chami, American University of Beirut Medical Center
- Investigators
- Hassan Chami, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741571
- Sponsor's protocol ID
- AmericanUBMC
- Status last verified
- Sep 2020
- First submitted
- 27 Nov 2012
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques
- ClinicalTrials.gov ID
- NCT01741571
- Acronym / sponsor ID
- AmericanUBMC
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 5 Dec 2012 (estimated)
- 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.
Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TBNA) techniques have not been well studied. The investigators will conduct a randomized study comparing the diagnostic yield and specimen quality of EBUS-FNA performed with and without suction applied.
Detailed description
Consecutive patients with suspected malignant peribronchial masses or lymph nodes undergoing endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) will be enrolled. All participants will have 4 needle aspirations of each targeted peribronchial lesion. Two needle aspirations will be performed while applying suction and 2 needle aspirations will be performed without applying suction in random order. The investigators will compare the diagnostic yield and the quality of the specimens obtained using the two techniques.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBUS guided FNA with suction | Active comparator | Device: EBUS guided FNA with and without suctionDevice/procedure: lymph node tissue collection using fine needle aspiration with suction applied. Four fine needle aspirations will be taken sequentially from each lymph node. Two with suction and two without suction applied. |
| EBUS guided FNA without suction | Experimental | Device: EBUS guided FNA with and without suctionDevice/procedure: lymph node tissue collection using fine needle aspiration without suction applied. Four fine needle aspirations will be taken sequentially from each lymph node. Two with suction and two without suction applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult undergoing EBUS at AUBMC for suspected malignancy
Key exclusion criteria (2 listed)
- Coagulopathy
- The lesion cannot be sampled because of intervening tumor or blood vessels.
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 |
|---|---|---|
| EBUS guided FNA with and without suctionDevice/procedure: lymph node tissue collection using needle with and without suction applied. Four fine needle aspirations will be taken from each lymph node. Two with suction and two without suction applied. | Device | EBUS guided FNA with suction, EBUS guided FNA without suction |
Primary outcome
Sensitivity of each needle aspiration technique for diagnosis of malignancy
Time frame: Diagnosis of malignancy will be ascertained after 6 month clinical follow up
A pathologist blinded to the needle aspiration technique will review the specimen obtained from each needle aspiration and will assess for presence of malignant cells. The sensitivity for diagnosing malignancy will be calculated and compared for the two needle aspiration technique.
Diagnostic accuracy of each needle aspiration technique for diagnosis of malignancy
Time frame: Diagnosis of malignancy will be ascertained after 6 month clinical follow up
A pathologist blinded to the needle aspiration technique will review the specimen obtained from each needle aspiration and will assess for presence of malignant cells. The diagnostic accuracy for diagnosing malignancy will be assessed and compared for the two needle aspiration technique.
4 secondary outcomes
Adequacy of the needle aspiration sample
Time frame: Adequacy will be assessed within 1 week from procedure
Negative predicted value of each needle aspiration technique for diagnosis of malignancy
Time frame: Diagnosis of malignancy will be ascertained after 6 month of clinical follow up
Specificity of each needle aspiration technique for diagnosis of malignancy
Time frame: Diagnosis of malignancy will be ascertained after 6 month clinical follow up
Positive predicted value of each needle aspiration technique for diagnosis of malignancy
Time frame: Diagnosis of Malignancy will be ascertained after 6 month of clinical follow up
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 21 Sep 2020.
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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.
Hassan Chami, MD principal investigator
American University of Beirut Medical 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 EBUS guided FNA with and without suction in people with Lung Cancer, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 1 inclusion and 2 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 21 Sep 2020. 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 Lebanon. 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?
Sensitivity of each needle aspiration technique for diagnosis of malignancy (time frame: Diagnosis of malignancy will be ascertained after 6 month clinical follow up). The study lists 2 primary outcomes in all. 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 21 Sep 2020.