Transbronchial Needle Aspiration in the Diagnosis of Peripheral Pulmonary Malignancy

Pulmonary Nodule Clinical Trial

Official title:

Transbronchial Needle Aspiration in the Diagnosis of Peripheral Pulmonary Malignancy: Yield and Predictors of a Positive Aspirate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00917137
• Other study ID #: 02-Trisolini
• Status: Completed
• Phase: N/A
• First received: June 9, 2009
• Last updated: June 22, 2010
• Start date: July 2008
• Est. completion date: June 2010

Study information

• Verified date: June 2010
• Source: Maggiore Bellaria Hospital, Bologna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 76 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Pulmonary Mass
• Pulmonary Nodule

Intervention

Procedure:
• TBNA + transbronchial lung biopsy + bronchial washing

Locations

Country	Name	City	State
Italy	Maggiore Hospital	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Maggiore Bellaria Hospital, Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess sensitivity, specificity and accuracy of TBNA in the diagnosis of peripheral pulmonary lesions		1 year	No
Secondary	Evaluate the predictor variables associated with a positive TBNA result		1 year	No
Secondary	Compare the performance characteristics of TBNA and transbronchial lung biopsy		1 year	No