Transbronchial Needle Aspiration in the Diagnosis of Peripheral Pulmonary Malignancy

Completed

• Conditions: Pulmonary Nodule; Pulmonary Mass
• Interventions: Procedure: TBNA + transbronchial lung biopsy + bronchial washing

• Registration Number: NCT00917137
• Lead Sponsor: Maggiore Bellaria Hospital, Bologna

Brief Summary

The main purposes of this study are to assess the performance characteristics of transbronchial needle aspiration (TBNA) in the diagnosis of peripheral pulmonary lesions, and to identify the predictor variables of a positive aspirate.

Detailed Description

In a recent systematic literature review (Rivera PM, Mehta AC; Chest 2007; 132: 1318-1488) TBNA showed the highest sensitivity in the diagnostic bronchoscopic approach to peripheral pulmonary lesions, as compared to the other available sampling techniques (transbronchial biopsy, brushing, washings). However, the Authors conclude that the data regarding TBNA in this setting deserve cautious interpretation because of the limited number of studies and the large differences in sample size). We designed the present study to assess the performance characteristics of TBNA, alone and in comparison with those of transbronchial biopsy, in the diagnosis of peripheral pulmonary lesions.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-06-09
• Study First Submitted QC: 2009-06-09
• Study First Posted: 2009-06-10
• Status Verified: 2010-06
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Last Update Submitted: 2010-06-22
• Last Update Posted: 2010-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age 18 years and older
• Pulmonary nodule (< 3 cm) or mass (> 3 cm) at computed tomography

Exclusion Criteria

• Refusal to sign informed consent
• Uncontrolled coagulopathy
• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Peripheral pulmonary lesions	TBNA + transbronchial lung biopsy + bronchial washing	-

Primary Outcome Measures

Name	Time	Method
Assess sensitivity, specificity and accuracy of TBNA in the diagnosis of peripheral pulmonary lesions	1 year

Secondary Outcome Measures

Name	Time	Method
Evaluate the predictor variables associated with a positive TBNA result	1 year
Compare the performance characteristics of TBNA and transbronchial lung biopsy	1 year

Trial Locations

Locations (1)

Maggiore Hospital; 🇮🇹 Bologna, Italy