Transbronchial Needle Aspiration in the Diagnosis of Peripheral Pulmonary Malignancy

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Nodule; Pulmonary Mass
• Intervention / Treatment: Procedure: TBNA + transbronchial lung biopsy + bronchial washing

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40133
    • Maggiore Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients with pulmonary nodule or mass referred for bronchoscopy to the Thoracic Endoscopy Unit of Maggiore Hospital (Bologna Italy)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Peripheral pulmonary lesions	Procedure: TBNA + transbronchial lung biopsy + bronchial washing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assess sensitivity, specificity and accuracy of TBNA in the diagnosis of peripheral pulmonary lesions	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Maggiore Bellaria Hospital, Bologna

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: June 9, 2009
• First Submitted That Met QC Criteria: June 9, 2009
• First Posted (Estimate): June 10, 2009

Study Record Updates

• Last Update Posted (Estimate): June 23, 2010
• Last Update Submitted That Met QC Criteria: June 22, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Bronchoscopy; Lung cancer; Lung nodule; Transbronchial needle aspiration; Transbronchial lung biopsy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules
• Other Study ID Numbers: 02-Trisolini