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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: TBCA, TBNA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TBCA/TBNA<br>Under fluoroscopy first transbronchial forceps biopsy is performed, afterwards in random order transbronchial catheter aspiration(TBCA) and transbronchial needle aspiration (TBNA). | Procedure: TBCA, TBNA<br>* 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.<br>* Other names: transbronchial biopsy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic sensitivity of transbronchial catheter aspiration in comparison with transbronchial needle aspiration. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yield by combination of the applied techniques |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, transbronchial biopsy, transbronchial catheter aspiration, transbronchial needle aspiration, peripheral pulmonary lesion, bronchoscopy