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

This study has been completed.

Sponsor:

Information provided by:

Helios Klinik Ambrock

ClinicalTrials.gov Identifier:

NCT00807391

First received: December 9, 2008

Last updated: June 22, 2011

Last verified: August 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

December 9, 2008

Last Updated Date

June 22, 2011

Start Date ^ICMJE

July 2009

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Diagnostic sensitivity of transbronchial catheter aspiration in comparison with transbronchial needle aspiration. [ Time Frame: one year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00807391 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Yield by combination of the applied techniques [ Time Frame: one year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Lung Cancer

Intervention ^ICMJE

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.

Other Name: transbronchial biopsy

Study Arm (s)

TBCA/TBNA

Under fluoroscopy first transbronchial forceps biopsy is performed, afterwards in random order transbronchial catheter aspiration(TBCA) and transbronchial needle aspiration (TBNA).

Intervention: Procedure: TBCA, TBNA

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2010

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00807391

Other Study ID Numbers ^ICMJE

HELIOS 2090

Has Data Monitoring Committee

Responsible Party

Karl-Josef Franke, MD, Helios Klinik Ambrock

Study Sponsor ^ICMJE

Helios Klinik Ambrock

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Karl-Josef Franke, MD

Helios Klinik Ambrock

Information Provided By

Helios Klinik Ambrock

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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