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

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Procedure: TBCA, TBNA

• Registration Number: NCT00807391
• Lead Sponsor: Helios Klinik Ambrock

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 Timeline

• Study First Submitted: 2008-12-09
• Study First Submitted QC: 2008-12-09
• Study First Posted: 2008-12-11
• Study Start: 2009-07
• Status Verified: 2009-08
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Diagnostic sensitivity of transbronchial catheter aspiration in comparison with transbronchial needle aspiration.	one year

Secondary Outcome Measures

Name	Time	Method
Yield by combination of the applied techniques	one year

Trial Locations

Locations (2)

Helios Klinik Ambrock, Department of Pneumology and Critical Care Medicine; 🇩🇪 Hagen, NRW, Germany

Universitätsklinikum Essen, Institut für Pathologie; 🇩🇪 Essen, NRW, Germany