Lung CancerNCT00741247
Mediastinal Staging of Lung Cancer With EBUS-TBNA and EUS-B-FNA
A study testing EBUS-TBNA, EUS-B-FNA (EUS-FNA with bronchoscope) in people with Lung Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
The purpose of this study is to find a role of EUS-B-FNA in the mediastinal staging of potentially operable lung cancer. The investigators perform EBUS-TBNA and EUS-B-FNA on potentially operable lung cancer patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- What is being tested?
- EBUS-TBNA, EUS-B-FNA (EUS-FNA with bronchoscope)
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2008to Mar 2009
- 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
- Histologically confirmed or strongly suspected potentially operable non-small cell lung cancer (NSCLC)
- Potentially operable patients
Who cannot join
- After staging work-up for NSCLC, including bronchoscopy,CT of the chest and upper abdomen, integrated PET/CT and brain MRI (and/or bone scan)
- 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
- Contraindications for bronchoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimally Invasive Mediastinal Staging of Potentially Operable Lung Cancer With Endobronchial Ultrasound Guided Transbronchial Needle Aspiration(EBUS-TBNA) and Transesophageal Aspiration Using Ultrasonic Bronchoscope (EUS-B-FNA)
The purpose of this study is to find a role of EUS-B-FNA in the mediastinal staging of potentially operable lung cancer. The investigators perform EBUS-TBNA and EUS-B-FNA on potentially operable lung cancer patients. The investigators perform EBUS(+/- TBNA) and EUS-B (ultrasonographic examination through the esophagus) on all subjects. EUS-B-FNA will be performed on inaccessible nodes or difficult nodes to be sampled by EBUS-TBNA. Additional diagnostic values of EUS-B-FNA as compared to EBUS-TBNA alone will be estimated.
- Conditions
- Lung Cancer
- Being tested
- EBUS-TBNA, EUS-B-FNA (EUS-FNA with bronchoscope)
- Keywords
- staging, Endobronchial ultrasound, Endoscopic ultrasound
- 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-TBNA, EUS-B-FNA (EUS-FNA with bronchoscope)Procedure or surgery
EBUS-TBNA is a bronchoscopic diagnostic method that enables real time aspiration of paratracheal and peribronchial lesions. EUS-FNA is a procedure to obtain samples through the esophagus under real-time ultrasound guidance. In this study, EUS-FNA will be applied using a ultrasonic bronchoscope (EUS-B-FNA).
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic values of EBUS-TBNA plus EUS-B-FNA as compared to EBUS-TBNA alone
Measured: June 2009
Secondary outcomes (1)
The Proportion and the location of lymph nodes accessible by EBUS-TBNA and EUS-B-FNA.
Measured: June 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionMar 2009
- Study completionMar 2009
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741247
- Sponsor's protocol ID
- NCCCTS-08-332
- Status last verified
- Jun 2009
- First submitted
- 25 Aug 2008
- Last updated
- 24 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hwangbo B, Lee GK, Lee HS, Lim KY, Lee SH, Kim HY, Lee HS, Kim MS, Lee JM, Nam BH, Zo JI. Transbronchial and transesophageal fine-needle aspiration using an ultrasound bronchoscope in mediastinal staging of potentially operable lung cancer. Chest. 2010 Oct;138(4):795-802. doi: 10.1378/chest.09-2100. Epub 2010 Mar 26.
PubMed 20348194
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Mediastinal Staging of Potentially Operable Lung Cancer With Endobronchial Ultrasound Guided Transbronchial Needle Aspiration(EBUS-TBNA) and Transesophageal Aspiration Using Ultrasonic Bronchoscope (EUS-B-FNA)
- ClinicalTrials.gov ID
- NCT00741247
- Acronym / sponsor ID
- NCCCTS-08-332
- Conditions
- Lung Cancer
- Keywords
- staging, Endobronchial ultrasound, Endoscopic ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Aug 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 26 Aug 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 purpose of this study is to find a role of EUS-B-FNA in the mediastinal staging of potentially operable lung cancer. The investigators perform EBUS-TBNA and EUS-B-FNA on potentially operable lung cancer patients. The investigators perform EBUS(+/- TBNA) and EUS-B (ultrasonographic examination through the esophagus) on all subjects. EUS-B-FNA will be performed on inaccessible nodes or difficult nodes to be sampled by EBUS-TBNA. Additional diagnostic values of EUS-B-FNA as compared to EBUS-TBNA alone will be estimated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically confirmed or strongly suspected potentially operable non-small cell lung cancer (NSCLC)
- Potentially operable patients
Key exclusion criteria (8 listed)
- After staging work-up for NSCLC, including bronchoscopy,CT of the chest and upper abdomen, integrated PET/CT and brain MRI (and/or bone scan)
- M1 disease
- Inoperable T4 disease
- Mediastinal infiltration or extranodal invasion of the mediastinal lymph node visible on chest CT.
- Confirmed supraclavicular lymph node metastasis
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-TBNA, EUS-B-FNA (EUS-FNA with bronchoscope)EBUS-TBNA is a bronchoscopic diagnostic method that enables real time aspiration of paratracheal and peribronchial lesions. EUS-FNA is a procedure to obtain samples through the esophagus under real-time ultrasound guidance. In this study, EUS-FNA will be applied using a ultrasonic bronchoscope (EUS-B-FNA). | Procedure or surgery | – |
Primary outcome
The diagnostic values of EBUS-TBNA plus EUS-B-FNA as compared to EBUS-TBNA alone
Time frame: June 2009
1 secondary outcome
The Proportion and the location of lymph nodes accessible by EBUS-TBNA and EUS-B-FNA.
Time frame: June 2009
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 24 Jun 2009.
- Derived from this study: PubMed 20348194Hwangbo B, Lee GK, Lee HS, Lim KY, Lee SH, Kim HY, Lee HS, Kim MS, Lee JM, Nam BH, Zo JI. Transbronchial and transesophageal fine-needle aspiration using an ultrasound bronchoscope in mediastinal staging of potentially operable lung cancer. Chest. 2010 Oct;138(4):795-802. doi: 10.1378/chest.09-2100. Epub 2010 Mar 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-TBNA, EUS-B-FNA (EUS-FNA with bronchoscope) in people with 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 8 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 24 Jun 2009. 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?
The diagnostic values of EBUS-TBNA plus EUS-B-FNA as compared to EBUS-TBNA alone (time frame: June 2009). 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 NCT00741247, 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 24 Jun 2009.