Peripheral Pulmonary LesionsNCT00626587
EBUS-Guided TBNA Increases the Diagnostic Yield of Peripheral Pulmonary Lesions
A study testing Olympus NA-2C-1 Transbronchial needle aspiration (TBNA) in people with Peripheral Pulmonary Lesions, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The diagnosis of peripheral pulmonary lesions(PPLs) remained a clinical challenge for physicians. Bronchoscope with sampling procedures was recognized as a useful method to obtain the correct diagnosis of PPLs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Pulmonary Lesions
- What is being tested?
- Olympus NA-2C-1 Transbronchial needle aspiration (TBNA)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2005to Dec 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with peripheral pulmonary lesions (PPLs)
Who cannot join
- Repeated bronchoscopic examination
- Positive endobronchial lesions
- Negative EBUS findings
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chang Gung Memorial Hospital-Kaohsiung Medical Center
Niaosung Shiang, Kaohsiung, 833
About this study
Official title: Endobronchial Ultrasonography-Guided Transbronchial Needle Aspiration Increases the Diagnostic Yield of Peripheral Pulmonary Lesions : A Randomized Trial
The diagnosis of peripheral pulmonary lesions(PPLs) remained a clinical challenge for physicians. Bronchoscope with sampling procedures was recognized as a useful method to obtain the correct diagnosis of PPLs. Conventional diagnostic procedures included transbronchial biopsy(TBB), bronchial washing(BW), or bronchial brushing, but the diagnostic yields were sometimes suboptimal. The diagnostic role of TBNA for PPLs remained to be determined, since many of the published studies were retrospective and had small sample size. This may explain the fact that TBNA was always underutilized for PPLs by bronchologists. With the popular application of EBUS-guided procedures in clinical setting, we performed EBUS-guided TBNA for PPLs. We want to determine whether EBUS-guided TBNA can improve the diagnostic rate of PPLs.
Read the detailed description
The diagnostic yield of endobronchial ultrasonography (EBUS)-guided transbronchial needle aspiration (TBNA) for peripheral pulmonary lesions (PPLs) had not been evaluated. The diagnostic impact of TBNA when the EBUS probe was adjacent to lesions remained to be determined.
Here we designed a randomized, prospective study to evaluate : (1) The diagnostic yield of EBUS-guided TBNA in PPLs; (2) The role of TBNA when EBUS probe was adjacent to the lesions. Lesions not visible by bronchoscopy were defined as PPLs (no findings of endobronchial lesions, extrinsic compression, submucosal infiltration, or orifice narrowing). The TBNA apparatus (Olympus NA-2C-1) was inserted through the working channel, and was advanced until it reached the target lesion which was localized by EBUS. Negative manual suction was applied with the 20 ml syringe. The specimens were then smeared on glass slides and immersed in 95% alcohol. At least 3 aspirates per lesion were obtained. Using simple randomization with random digit table, we randomly assigned patients to undergo EBUS-guided TBB and BW or EBUS-guided TBNA, TBB and BW.
- Conditions
- Peripheral Pulmonary Lesions
- Being tested
- Olympus NA-2C-1 Transbronchial needle aspiration (TBNA)
- Keywords
- Endobronchial ultrasonography, Peripheral pulmonary lesions, Transbronchial needle aspiration, Probe location, Diagnostic yield, EBUS guided TBNA for peripheral pulmonary lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olympus NA-2C-1 Transbronchial needle aspiration (TBNA)Device
Also called TBNA apparatus (Olympus NA-2C-1) for bronchoscopic sampling
The TBNA apparatus (Olympus NA-2C-1) is inserted through the working channel, and is advanced until it reaches the target lesion which is localized by EBUS. Negative manual suction is applied with the 20 ml syringe. The specimens are then smeared on glass slides and immersed in 95% alcohol. At least 3 aspirates per lesion are obtained.
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Conventional diagnostic procedures (transbronchial biopsy and bronchial washing) for peripheral pulmonary lesions Receives: Device: Olympus NA-2C-1 Transbronchial needle aspiration (TBNA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic yield of EBUS-guided TBNA in PPLs
Measured: Follow up of final diagnosis
Secondary outcomes (1)
The role of TBNA when EBUS probe was adjacent to the lesions
Measured: Follow up of diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startJan 2005
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Pulmonary LesionsStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Lin Meng-Chih, MD, Principal investigator, Chang Gung Memorial Hospital-Kaohsiung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626587
- Sponsor's protocol ID
- CGMH-94-0101A
- Other IDs
- 96-0861B
- Status last verified
- Jan 2005
- First submitted
- 21 Feb 2008
- Last updated
- 29 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chao TY, Chien MT, Lie CH, Chung YH, Wang JL, Lin MC. Endobronchial ultrasonography-guided transbronchial needle aspiration increases the diagnostic yield of peripheral pulmonary lesions: a randomized trial. Chest. 2009 Jul;136(1):229-236. doi: 10.1378/chest.08-0577. Epub 2008 Sep 23.
PubMed 18812446
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endobronchial Ultrasonography-Guided Transbronchial Needle Aspiration Increases the Diagnostic Yield of Peripheral Pulmonary Lesions : A Randomized Trial
- ClinicalTrials.gov ID
- NCT00626587
- Acronym / sponsor ID
- CGMH-94-0101A
- Conditions
- Peripheral Pulmonary Lesions
- Keywords
- Endobronchial ultrasonography, Peripheral pulmonary lesions, Transbronchial needle aspiration, Probe location, Diagnostic yield, EBUS guided TBNA for peripheral pulmonary lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 29 Feb 2008 (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.
The diagnosis of peripheral pulmonary lesions(PPLs) remained a clinical challenge for physicians. Bronchoscope with sampling procedures was recognized as a useful method to obtain the correct diagnosis of PPLs. Conventional diagnostic procedures included transbronchial biopsy(TBB), bronchial washing(BW), or bronchial brushing, but the diagnostic yields were sometimes suboptimal. The diagnostic role of TBNA for PPLs remained to be determined, since many of the published studies were retrospective and had small sample size. This may explain the fact that TBNA was always underutilized for PPLs by bronchologists. With the popular application of EBUS-guided procedures in clinical setting, we performed EBUS-guided TBNA for PPLs. We want to determine whether EBUS-guided TBNA can improve the diagnostic rate of PPLs.
Detailed description
The diagnostic yield of endobronchial ultrasonography (EBUS)-guided transbronchial needle aspiration (TBNA) for peripheral pulmonary lesions (PPLs) had not been evaluated. The diagnostic impact of TBNA when the EBUS probe was adjacent to lesions remained to be determined.
Here we designed a randomized, prospective study to evaluate : (1) The diagnostic yield of EBUS-guided TBNA in PPLs; (2) The role of TBNA when EBUS probe was adjacent to the lesions. Lesions not visible by bronchoscopy were defined as PPLs (no findings of endobronchial lesions, extrinsic compression, submucosal infiltration, or orifice narrowing). The TBNA apparatus (Olympus NA-2C-1) was inserted through the working channel, and was advanced until it reached the target lesion which was localized by EBUS. Negative manual suction was applied with the 20 ml syringe. The specimens were then smeared on glass slides and immersed in 95% alcohol. At least 3 aspirates per lesion were obtained. Using simple randomization with random digit table, we randomly assigned patients to undergo EBUS-guided TBB and BW or EBUS-guided TBNA, TBB and BW.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Device: Olympus NA-2C-1 Transbronchial needle aspiration (TBNA)Conventional diagnostic procedures (transbronchial biopsy and bronchial washing) for peripheral pulmonary lesions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with peripheral pulmonary lesions (PPLs)
Key exclusion criteria (3 listed)
- Repeated bronchoscopic examination
- Positive endobronchial lesions
- Negative EBUS findings
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 |
|---|---|---|
| Olympus NA-2C-1 Transbronchial needle aspiration (TBNA)Also: TBNA apparatus (Olympus NA-2C-1) for bronchoscopic samplingThe TBNA apparatus (Olympus NA-2C-1) is inserted through the working channel, and is advanced until it reaches the target lesion which is localized by EBUS. Negative manual suction is applied with the 20 ml syringe. The specimens are then smeared on glass slides and immersed in 95% alcohol. At least 3 aspirates per lesion are obtained. | Device | A |
Primary outcome
The diagnostic yield of EBUS-guided TBNA in PPLs
Time frame: Follow up of final diagnosis
1 secondary outcome
The role of TBNA when EBUS probe was adjacent to the lesions
Time frame: Follow up of diagnosis
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 29 Feb 2008.
- Derived from this study: PubMed 18812446Chao TY, Chien MT, Lie CH, Chung YH, Wang JL, Lin MC. Endobronchial ultrasonography-guided transbronchial needle aspiration increases the diagnostic yield of peripheral pulmonary lesions: a randomized trial. Chest. 2009 Jul;136(1):229-236. doi: 10.1378/chest.08-0577. Epub 2008 Sep 23.
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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.
Lin Meng-Chih, MD principal investigator
Chang Gung Memorial Hospital-Kaohsiung 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 Olympus NA-2C-1 Transbronchial needle aspiration (TBNA) in people with Peripheral Pulmonary Lesions, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 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 29 Feb 2008. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
The diagnostic yield of EBUS-guided TBNA in PPLs (time frame: Follow up of final diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00626587, which also lists 1 linked publication.
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 29 Feb 2008.