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Completed

NCT Number: NCT00807391

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Essen, Institut für Pathologie, Essen, North Rhine-Westphalia, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TBCA, TBNA

Procedure

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 names: transbronchial biopsy

Primary outcomes

  1. Diagnostic sensitivity of transbronchial catheter aspiration in comparison with transbronchial needle aspiration.

    Time frame: one year

Secondary outcomes

  1. Yield by combination of the applied techniques

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Helios Klinik Ambrock

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 11, 2008
Registry last updated
Jun 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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