Transbronchial Catheter Aspiration and Transbronchial Needle Aspiration in the Diagnosis of Lung Cancer

Lung Cancer Clinical Trial

Official title:

Transbronchial Catheter Aspiration Compared to Transbronchial Needle Aspiration in the Diagnosis of Peripheral Nodules and Masses of the Lung

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807391
• Other study ID #: HELIOS 2090
• Status: Completed
• Phase: N/A
• First received: December 9, 2008
• Last updated: June 22, 2011
• Start date: July 2009
• Est. completion date: November 2010

Study information

• Verified date: August 2009
• Source: Helios Klinik Ambrock
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• TBCA, TBNA
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.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Essen, Institut für Pathologie	Essen	NRW
Germany	Helios Klinik Ambrock, Department of Pneumology and Critical Care Medicine	Hagen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Helios Klinik Ambrock

Country where clinical trial is conducted

Germany, 

References & Publications (6)

Chechani V. Bronchoscopic diagnosis of solitary pulmonary nodules and lung masses in the absence of endobronchial abnormality. Chest. 1996 Mar;109(3):620-5. — View Citation

Franke KJ, Nilius G, Rühle KH. [Frequency of cytological procedures in diagnostic bronchoscopy of peripheral pulmonary modules and masses]. Pneumologie. 2006 Nov;60(11):663-6. German. — View 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. — View 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. — View 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. — View Citation

Reichenberger F, Weber J, Tamm M, Bolliger CT, Dalquen P, Perruchoud AP, Solèr M. The value of transbronchial needle aspiration in the diagnosis of peripheral pulmonary lesions. Chest. 1999 Sep;116(3):704-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic sensitivity of transbronchial catheter aspiration in comparison with transbronchial needle aspiration.		one year	No
Secondary	Yield by combination of the applied techniques		one year	No