Lung CancerNCT00807391
Transbronchial Catheter Aspiration and Transbronchial Needle Aspiration in the Diagnosis of Lung Cancer
A study testing TBCA, TBNA in people with Lung Cancer, run by Helios Klinik Ambrock at 2 sites in Germany.
Trial summary
The aim of this study is prospectively to determine the diagnostic sensitivity of Transbronchial Catheter Aspiration (TBCA) in comparison with Transbronchial Needle Aspiration (TBNA) in the diagnosis of peripheral nodules and masses of the lung. 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?
- TBCA, TBNA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesGermany
- Study dates
- Jul 2009to Nov 2010
- 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
- informed consent prior to the procedure
- radiologically peripheral pulmonary lesions between 10 and 60 millimeters in diameter
Who cannot join
- endoscopically visible lung carcinoma
- no consent in further diagnostic procedures, when bronchoscopy fails to establish a diagnosis
- haemorrhagic syndrome; grave cardiac disease; oxygen saturation lower than 90 percent
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Universitätsklinikum Essen, Institut für Pathologie
Essen, North Rhine-Westphalia, 45122
Helios Klinik Ambrock, Department of Pneumology and Critical Care Medicine
Hagen, North Rhine-Westphalia, 58091
About this study
Official title: Transbronchial Catheter Aspiration Compared to Transbronchial Needle Aspiration in the Diagnosis of Peripheral Nodules and Masses of the Lung
The aim of this study is prospectively to determine the diagnostic sensitivity of Transbronchial Catheter Aspiration (TBCA) in comparison with Transbronchial Needle Aspiration (TBNA) in the diagnosis of peripheral nodules and masses of the lung.
Read the detailed description
The yield of transbronchial forceps biopsy under fluoroscopy in the diagnosis of peripheral lesion of the lung lies between 32 and 57%. Several studies prove an amelioration of success rates by addition of cytological methods such as TBNA, TBCA and bronchial brushing. Furthermore, for TBNA and TBCA a significantly higher yield was reported in comparison with transbronchial forceps biopsy. TBNA and TBCA are routinely used methods, both techniques are safe, the instruments used are certificated.
- Conditions
- Lung Cancer
- Being tested
- TBCA, TBNA
- Keywords
- lung cancer, transbronchial biopsy, transbronchial catheter aspiration, transbronchial needle aspiration, peripheral pulmonary lesion, bronchoscopy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBCA, TBNAProcedure or surgery
Also called transbronchial biopsy
One arm, in random order first transbronchial catheter aspiration and second transbronchial needle aspiration or vice verse, both techniques routinely used in the diagnosis of peripheral pulmonary lesions; the cytological specimens of TBCA and TBNA are in random order examined by two independent cytologists, all cytological specimens are afterwards examined by a third, supervising cytologist.
| Study group | Role | What they receive |
|---|---|---|
| TBCA/TBNA | Other | Under fluoroscopy first transbronchial forceps biopsy is performed, afterwards in random order transbronchial catheter aspiration(TBCA) and transbronchial needle aspiration (TBNA). Receives: Procedure: TBCA, TBNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic sensitivity of transbronchial catheter aspiration in comparison with transbronchial needle aspiration.
Measured: one year
Secondary outcomes (1)
Yield by combination of the applied techniques
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startJul 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helios Klinik Ambrock
- Sponsor type
- University, hospital or other
- Investigators
- Karl-Josef Franke, MD, Principal investigator, Helios Klinik Ambrock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807391
- Sponsor's protocol ID
- HELIOS 2090
- Status last verified
- Aug 2009
- First submitted
- 9 Dec 2008
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Franke KJ, Nilius G, Ruhle KH. [Frequency of cytological procedures in diagnostic bronchoscopy of peripheral pulmonary modules and masses]. Pneumologie. 2006 Nov;60(11):663-6. doi: 10.1055/s-2006-944263. German.
PubMed 17109263Gasparini S, Ferretti M, Secchi EB, Baldelli S, Zuccatosta L, Gusella P. Integration of transbronchial and percutaneous approach in the diagnosis of peripheral pulmonary nodules or masses. Experience with 1,027 consecutive cases. Chest. 1995 Jul;108(1):131-7. doi: 10.1378/chest.108.1.131.
PubMed 7606947Chechani V. Bronchoscopic diagnosis of solitary pulmonary nodules and lung masses in the absence of endobronchial abnormality. Chest. 1996 Mar;109(3):620-5. doi: 10.1378/chest.109.3.620.
PubMed 8617067Reichenberger F, Weber J, Tamm M, Bolliger CT, Dalquen P, Perruchoud AP, Soler M. The value of transbronchial needle aspiration in the diagnosis of peripheral pulmonary lesions. Chest. 1999 Sep;116(3):704-8. doi: 10.1378/chest.116.3.704.
PubMed 10492275Katis K, Inglesos E, Zachariadis E, Palamidas P, Paraskevopoulos I, Sideris G, Tamvakopoulou E, Apostolopoulou F, Rasidakis A. The role of transbronchial needle aspiration in the diagnosis of peripheral lung masses or nodules. Eur Respir J. 1995 Jun;8(6):963-6.
PubMed 7589384Franke KJ, Nilius G, Ruhle KH. Transbronchial catheter aspiration compared to forceps biopsy in the diagnosis of peripheral lung cancer. Eur J Med Res. 2009 Jan 28;14(1):13-7. doi: 10.1186/2047-783x-14-1-13.
PubMed 19258205
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transbronchial Catheter Aspiration Compared to Transbronchial Needle Aspiration in the Diagnosis of Peripheral Nodules and Masses of the Lung
- ClinicalTrials.gov ID
- NCT00807391
- Acronym / sponsor ID
- HELIOS 2090
- Conditions
- Lung Cancer
- Keywords
- lung cancer, transbronchial biopsy, transbronchial catheter aspiration, transbronchial needle aspiration, peripheral pulmonary lesion, bronchoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Helios Klinik AmbrockUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 11 Dec 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 aim of this study is prospectively to determine the diagnostic sensitivity of Transbronchial Catheter Aspiration (TBCA) in comparison with Transbronchial Needle Aspiration (TBNA) in the diagnosis of peripheral nodules and masses of the lung.
Detailed description
The yield of transbronchial forceps biopsy under fluoroscopy in the diagnosis of peripheral lesion of the lung lies between 32 and 57%. Several studies prove an amelioration of success rates by addition of cytological methods such as TBNA, TBCA and bronchial brushing. Furthermore, for TBNA and TBCA a significantly higher yield was reported in comparison with transbronchial forceps biopsy. TBNA and TBCA are routinely used methods, both techniques are safe, the instruments used are certificated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TBCA/TBNA | Other | Procedure: TBCA, TBNAUnder fluoroscopy first transbronchial forceps biopsy is performed, afterwards in random order transbronchial catheter aspiration(TBCA) and transbronchial needle aspiration (TBNA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- informed consent prior to the procedure
- radiologically peripheral pulmonary lesions between 10 and 60 millimeters in diameter
Key exclusion criteria (3 listed)
- endoscopically visible lung carcinoma
- no consent in further diagnostic procedures, when bronchoscopy fails to establish a diagnosis
- haemorrhagic syndrome; grave cardiac disease; oxygen saturation lower than 90 percent
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 |
|---|---|---|
| TBCA, TBNAAlso: transbronchial biopsyOne arm, in random order first transbronchial catheter aspiration and second transbronchial needle aspiration or vice verse, both techniques routinely used in the diagnosis of peripheral pulmonary lesions; the cytological specimens of TBCA and TBNA are in random order examined by two independent cytologists, all cytological specimens are afterwards examined by a third, supervising cytologist. | Procedure or surgery | TBCA/TBNA |
Primary outcome
Diagnostic sensitivity of transbronchial catheter aspiration in comparison with transbronchial needle aspiration.
Time frame: one year
1 secondary outcome
Yield by combination of the applied techniques
Time frame: one year
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 23 Jun 2011.
- Background: PubMed 17109263Franke KJ, Nilius G, Ruhle KH. [Frequency of cytological procedures in diagnostic bronchoscopy of peripheral pulmonary modules and masses]. Pneumologie. 2006 Nov;60(11):663-6. doi: 10.1055/s-2006-944263. German.
- Background: PubMed 7606947Gasparini S, Ferretti M, Secchi EB, Baldelli S, Zuccatosta L, Gusella P. Integration of transbronchial and percutaneous approach in the diagnosis of peripheral pulmonary nodules or masses. Experience with 1,027 consecutive cases. Chest. 1995 Jul;108(1):131-7. doi: 10.1378/chest.108.1.131.
- Background: PubMed 8617067Chechani V. Bronchoscopic diagnosis of solitary pulmonary nodules and lung masses in the absence of endobronchial abnormality. Chest. 1996 Mar;109(3):620-5. doi: 10.1378/chest.109.3.620.
- Background: PubMed 10492275Reichenberger F, Weber J, Tamm M, Bolliger CT, Dalquen P, Perruchoud AP, Soler M. The value of transbronchial needle aspiration in the diagnosis of peripheral pulmonary lesions. Chest. 1999 Sep;116(3):704-8. doi: 10.1378/chest.116.3.704.
- Background: PubMed 7589384Katis K, Inglesos E, Zachariadis E, Palamidas P, Paraskevopoulos I, Sideris G, Tamvakopoulou E, Apostolopoulou F, Rasidakis A. The role of transbronchial needle aspiration in the diagnosis of peripheral lung masses or nodules. Eur Respir J. 1995 Jun;8(6):963-6.
- Background: PubMed 19258205Franke KJ, Nilius G, Ruhle KH. Transbronchial catheter aspiration compared to forceps biopsy in the diagnosis of peripheral lung cancer. Eur J Med Res. 2009 Jan 28;14(1):13-7. doi: 10.1186/2047-783x-14-1-13.
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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.
Karl-Josef Franke, MD principal investigator
Helios Klinik Ambrock
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TBCA, TBNA in people with Lung Cancer, run by Helios Klinik Ambrock at 2 sites in Germany.
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 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 sensitivity of transbronchial catheter aspiration in comparison with transbronchial needle aspiration. (time frame: one year). 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 NCT00807391, which also lists 6 linked publications.
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 23 Jun 2011.