Non Small Cell Lung CancerNCT01385111
Combined Application of EBUS and EUS in Lung Cancer
A study testing EUS-B-FNA followed by EBUS-TBNA and EBUS-TBNA followed by EUS-B-FNA in people with Non Small Cell Lung Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
This study aims to investigate a diagnostic yield and performance characteristics according to the order of endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) and endoscopic ultrasound-with bronchoscope-guided transbronchial needle aspiration (EUS-B-FNA) in the mediastinal staging of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- EUS-B-FNA followed by EBUS-TBNA and EBUS-TBNA followed by EUS-B-FNA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to Feb 2012
- 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
- Histologically confirmed or strongly suspected non-small cell lung cancer (NSCLC)
- Potentially operable patients
Who cannot join
- M1 disease
- Inoperable T4 disease
- Mediastinal infiltration or extranodal invasion of the mediastinal lymph node visible on chest CT.
- Confirmed supraclavicular lymph node metastasis
- Pancoast tumors
- Medically inoperable patients
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- Contraindications for bronchoscopy and esophageal endoscopy
- Drug reaction to lidocaine, midazolam,fentanyl
- Pregnancy
- Ground glass-dominant nodule ( < 3cm)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
National Cancer Center (NCC) Korea
Goyang-si, Gyeonggi-do, 410-769
About this study
Official title: Combined Application of EBUS-TBNA and EUS-B-FNA in Mediastinal Staging of Lung Cancer; EBUS-TBNA Centered Procedure vs. EUS-B-FNA Centered Procedure, a Randomized Study.
This study aims to investigate a diagnostic yield and performance characteristics according to the order of endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) and endoscopic ultrasound-with bronchoscope-guided transbronchial needle aspiration (EUS-B-FNA) in the mediastinal staging of potentially operable lung cancer. EUS-FNA is a better tolerated procedure than EBUS-TBNA. Therefore, EUS-B-FNA can be the main procedure in a combined approach with EBUS-TBNA and EUS-B-FNA. In group A, the investigators perform EBUS-TBNA first and EUS-B-FNA is performed when necessary. In group B, EUS-B-FNA is first applied and EBUS-TBNA is performed when necessary. The hypothesis is that the diagnostic yield of the EUS centered procedure is as good as that of the EBUS centered procedure and the EUS centered procedure is more tolerable than the EBUS centered procedure. We evaluate diagnostic yields and performance characteristics of each group.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- EUS-B-FNA followed by EBUS-TBNA, EBUS-TBNA followed by EUS-B-FNA
- Keywords
- endobronchial ultrasound, endoscopic ultrasound, EBUS-TBNA, EUS-FNA, EUS-B-FNA, lung cancer, staging
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-B-FNA followed by EBUS-TBNAProcedure or surgery
EUS-B-FNA will be performed followed by EBUS-TBNA when additional needle aspiration is necessary after EBUS-TBNA.
EBUS-TBNA followed by EUS-B-FNAProcedure or surgery
EBUS-TBNA will be performed followed by EUS-B-FNA when additional needle aspiration is necessary after EUS-B-FNA
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | EBUS centered Receives: Procedure: EUS-B-FNA followed by EBUS-TBNA |
| Arm B | Experimental | EUS centered Receives: Procedure: EBUS-TBNA followed by EUS-B-FNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Measured: When the confimative disgnosis is available in all subjects (after surgery) ; 8-12 months
Secondary outcomes (7)
Procedure time
Measured: During and just after the procedure ; 5-60 minutes
Cardiovascular measurement (change of blood pressure, changes of heart rate, number of patients with arrhythmia)
Measured: During the procedure; 0-60 minutes
Degree of desaturation
Measured: During the procedure; 0-60minutes
Discomfort by the procedure
Measured: After the procedure ; 2-3hr
Number of participants with adverse Events (infection, bleeding requiring intervention, pneumothorax, or any complications requiring hospital admission)
Measured: During and after the procedure; 0-2 weeks
Lymph node features
Measured: During and after the procedure; 0-2hrs
Fentanyl/midazolam/lidocaine consumption
Measured: After the procedure ; 1-2 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2012
- Study completionFeb 2012
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 Non Small Cell 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Investigators
- Bin Hwangbo, MD, PhD, Principal investigator, Medical Doctor, Senior Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385111
- Sponsor's protocol ID
- NCC-EUSEBUS
- Status last verified
- Jun 2011
- First submitted
- 23 Jun 2011
- Last updated
- 18 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kang HJ, Hwangbo B, Lee GK, Nam BH, Lee HS, Kim MS, Lee JM, Zo JI, Lee HS, Han JY. EBUS-centred versus EUS-centred mediastinal staging in lung cancer: a randomised controlled trial. Thorax. 2014 Mar;69(3):261-8. doi: 10.1136/thoraxjnl-2013-203881. Epub 2013 Oct 30.
PubMed 24172712
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Application of EBUS-TBNA and EUS-B-FNA in Mediastinal Staging of Lung Cancer; EBUS-TBNA Centered Procedure vs. EUS-B-FNA Centered Procedure, a Randomized Study.
- ClinicalTrials.gov ID
- NCT01385111
- Acronym / sponsor ID
- NCC-EUSEBUS
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- endobronchial ultrasound, endoscopic ultrasound, EBUS-TBNA, EUS-FNA, EUS-B-FNA, lung cancer, staging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Jun 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 29 Jun 2011 (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.
This study aims to investigate a diagnostic yield and performance characteristics according to the order of endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) and endoscopic ultrasound-with bronchoscope-guided transbronchial needle aspiration (EUS-B-FNA) in the mediastinal staging of potentially operable lung cancer. EUS-FNA is a better tolerated procedure than EBUS-TBNA. Therefore, EUS-B-FNA can be the main procedure in a combined approach with EBUS-TBNA and EUS-B-FNA. In group A, the investigators perform EBUS-TBNA first and EUS-B-FNA is performed when necessary. In group B, EUS-B-FNA is first applied and EBUS-TBNA is performed when necessary. The hypothesis is that the diagnostic yield of the EUS centered procedure is as good as that of the EBUS centered procedure and the EUS centered procedure is more tolerable than the EBUS centered procedure. We evaluate diagnostic yields and performance characteristics of each group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Procedure: EUS-B-FNA followed by EBUS-TBNAEBUS centered |
| Arm B | Experimental | Procedure: EBUS-TBNA followed by EUS-B-FNAEUS centered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically confirmed or strongly suspected non-small cell lung cancer (NSCLC)
- Potentially operable patients
Key exclusion criteria (10 listed)
- M1 disease
- Inoperable T4 disease
- Mediastinal infiltration or extranodal invasion of the mediastinal lymph node visible on chest CT.
- Confirmed supraclavicular lymph node metastasis
- Pancoast tumors
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 |
|---|---|---|
| EUS-B-FNA followed by EBUS-TBNAEUS-B-FNA will be performed followed by EBUS-TBNA when additional needle aspiration is necessary after EBUS-TBNA. | Procedure or surgery | Arm A |
| EBUS-TBNA followed by EUS-B-FNAEBUS-TBNA will be performed followed by EUS-B-FNA when additional needle aspiration is necessary after EUS-B-FNA | Procedure or surgery | Arm B |
Primary outcome
Diagnostic accuracy
Time frame: When the confimative disgnosis is available in all subjects (after surgery) ; 8-12 months
7 secondary outcomes
Procedure time
Time frame: During and just after the procedure ; 5-60 minutes
Cardiovascular measurement (change of blood pressure, changes of heart rate, number of patients with arrhythmia)
Time frame: During the procedure; 0-60 minutes
Degree of desaturation
Time frame: During the procedure; 0-60minutes
Discomfort by the procedure
Time frame: After the procedure ; 2-3hr
Number of participants with adverse Events (infection, bleeding requiring intervention, pneumothorax, or any complications requiring hospital admission)
Time frame: During and after the procedure; 0-2 weeks
Lymph node features
Time frame: During and after the procedure; 0-2hrs
Fentanyl/midazolam/lidocaine consumption
Time frame: After the procedure ; 1-2 hrs
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 18 Oct 2012.
- Derived from this study: PubMed 24172712Kang HJ, Hwangbo B, Lee GK, Nam BH, Lee HS, Kim MS, Lee JM, Zo JI, Lee HS, Han JY. EBUS-centred versus EUS-centred mediastinal staging in lung cancer: a randomised controlled trial. Thorax. 2014 Mar;69(3):261-8. doi: 10.1136/thoraxjnl-2013-203881. Epub 2013 Oct 30.
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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.
Bin Hwangbo, MD, PhD principal investigator
Medical Doctor, Senior Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-B-FNA followed by EBUS-TBNA and EBUS-TBNA followed by EUS-B-FNA in people with Non Small Cell Lung Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
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 10 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 18 Oct 2012. 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 South Korea. 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?
Diagnostic accuracy (time frame: When the confimative disgnosis is available in all subjects (after surgery) ; 8-12 months). 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 NCT01385111, 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 18 Oct 2012.