Clinical trial NCT00807391: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: lung cancer
transbronchial biopsy
transbronchial catheter aspiration
transbronchial needle aspiration
peripheral pulmonary lesion
bronchoscopy
Lead sponsor: Helios Klinik Ambrock
Sponsor class: OTHER
First posted: 2008-12-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Diagnostic sensitivity of transbronchial catheter aspiration in comparison with transbronchial needle aspiration.
timeFrame: one year
Secondary outcomes:
measure: Yield by combination of the applied techniques
timeFrame: one year
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Universitätsklinikum Essen, Institut für Pathologie
state: NRW
city: Hagen
country: Germany
facility: Helios Klinik Ambrock, Department of Pneumology and Critical Care Medicine
state: NRW
Study officials:
affiliation: Helios Klinik Ambrock
name: Karl-Josef Franke, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.