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
  Purpose

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 Intervention
Lung Cancer
Procedure: TBCA, TBNA

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Helios Klinik Ambrock:

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

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

Enrollment: 48
Study Start Date: July 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 9, 2008
Last Updated: June 22, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 16, 2014