Back to resultsTransbronchial Catheter Aspiration and Transbronchial Needle Aspiration in the Diagnosis of Lung Cancer
Primary Purpose
Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
TBCA, TBNA
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer focused on measuring lung cancer, transbronchial biopsy, transbronchial catheter aspiration, transbronchial needle aspiration, peripheral pulmonary lesion, bronchoscopy
Eligibility Criteria
Inclusion Criteria:
- informed consent prior to the procedure
- radiologically peripheral pulmonary lesions between 10 and 60 millimeters in diameter
Exclusion Criteria:
- 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
Sites / Locations
- Universitätsklinikum Essen, Institut für Pathologie
- Helios Klinik Ambrock, Department of Pneumology and Critical Care Medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
TBCA/TBNA
Arm Description
Under fluoroscopy first transbronchial forceps biopsy is performed, afterwards in random order transbronchial catheter aspiration(TBCA) and transbronchial needle aspiration (TBNA).
Outcomes
Primary Outcome Measures
Diagnostic sensitivity of transbronchial catheter aspiration in comparison with transbronchial needle aspiration.
Secondary Outcome Measures
Yield by combination of the applied techniques
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00807391
Brief Title
Transbronchial Catheter Aspiration and Transbronchial Needle Aspiration in the Diagnosis of Lung Cancer
Official Title
Transbronchial Catheter Aspiration Compared to Transbronchial Needle Aspiration in the Diagnosis of Peripheral Nodules and Masses of the Lung
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Helios Klinik Ambrock
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
lung cancer, transbronchial biopsy, transbronchial catheter aspiration, transbronchial needle aspiration, peripheral pulmonary lesion, bronchoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TBCA/TBNA
Arm Type
Other
Arm Description
Under fluoroscopy first transbronchial forceps biopsy is performed, afterwards in random order transbronchial catheter aspiration(TBCA) and transbronchial needle aspiration (TBNA).
Intervention Type
Procedure
Intervention Name(s)
TBCA, TBNA
Other Intervention Name(s)
transbronchial biopsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diagnostic sensitivity of transbronchial catheter aspiration in comparison with transbronchial needle aspiration.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Yield by combination of the applied techniques
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
informed consent prior to the procedure
radiologically peripheral pulmonary lesions between 10 and 60 millimeters in diameter
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl-Josef Franke, MD
Organizational Affiliation
Helios Klinik Ambrock
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Essen, Institut für Pathologie
City
Essen
State/Province
NRW
ZIP/Postal Code
45122
Country
Germany
Facility Name
Helios Klinik Ambrock, Department of Pneumology and Critical Care Medicine
City
Hagen
State/Province
NRW
ZIP/Postal Code
58091
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
17109263
Citation
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.
Results Reference
background
PubMed Identifier
7606947
Citation
Gasparini 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.
Results Reference
background
PubMed Identifier
8617067
Citation
Chechani 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.
Results Reference
background
PubMed Identifier
10492275
Citation
Reichenberger 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.
Results Reference
background
PubMed Identifier
7589384
Citation
Katis 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.
Results Reference
background
PubMed Identifier
19258205
Citation
Franke 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.
Results Reference
background
Learn more about this trial
Transbronchial Catheter Aspiration and Transbronchial Needle Aspiration in the Diagnosis of Lung Cancer
We'll reach out to this number within 24 hrs