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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00807391
Recruitment Status : Completed
First Posted : December 11, 2008
Last Update Posted : June 23, 2011
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment
Lung Cancer Procedure: TBCA, TBNA

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Transbronchial Catheter Aspiration Compared to Transbronchial Needle Aspiration in the Diagnosis of Peripheral Nodules and Masses of the Lung
Study Start Date : July 2009
Primary Completion Date : November 2010
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Diagnostic sensitivity of transbronchial catheter aspiration in comparison with transbronchial needle aspiration. [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Yield by combination of the applied techniques [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00807391


Locations
Germany
Universitätsklinikum Essen, Institut für Pathologie
Essen, NRW, Germany, 45122
Helios Klinik Ambrock, Department of Pneumology and Critical Care Medicine
Hagen, NRW, Germany, 58091
Sponsors and Collaborators
Helios Klinik Ambrock
Investigators
Principal Investigator: Karl-Josef Franke, MD Helios Klinik Ambrock
More Information

Publications:
Responsible Party: Karl-Josef Franke, MD, Helios Klinik Ambrock
ClinicalTrials.gov Identifier: NCT00807391     History of Changes
Other Study ID Numbers: HELIOS 2090
First Posted: December 11, 2008    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: August 2009

Keywords provided by Helios Klinik Ambrock:
lung cancer
transbronchial biopsy
transbronchial catheter aspiration
transbronchial needle aspiration
peripheral pulmonary lesion
bronchoscopy

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases