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Transbronchial Needle Aspiration in the Diagnosis of Peripheral Pulmonary Malignancy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00917137
First Posted: June 10, 2009
Last Update Posted: June 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Maggiore Bellaria Hospital, Bologna
  Purpose
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.

Condition Intervention
Pulmonary Nodule Pulmonary Mass Procedure: TBNA + transbronchial lung biopsy + bronchial washing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transbronchial Needle Aspiration in the Diagnosis of Peripheral Pulmonary Malignancy: Yield and Predictors of a Positive Aspirate

Resource links provided by NLM:


Further study details as provided by Maggiore Bellaria Hospital, Bologna:

Primary Outcome Measures:
  • Assess sensitivity, specificity and accuracy of TBNA in the diagnosis of peripheral pulmonary lesions [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Evaluate the predictor variables associated with a positive TBNA result [ Time Frame: 1 year ]
  • Compare the performance characteristics of TBNA and transbronchial lung biopsy [ Time Frame: 1 year ]

Estimated Enrollment: 200
Study Start Date: July 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Peripheral pulmonary lesions 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.
  Eligibility

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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00917137


Locations
Italy
Maggiore Hospital
Bologna, Italy, 40133
Sponsors and Collaborators
Maggiore Bellaria Hospital, Bologna
  More Information

Responsible Party: Marco Patelli, Maggiore Bellaria Hospital
ClinicalTrials.gov Identifier: NCT00917137     History of Changes
Other Study ID Numbers: 02-Trisolini
First Submitted: June 9, 2009
First Posted: June 10, 2009
Last Update Posted: June 23, 2010
Last Verified: June 2010

Keywords provided by Maggiore Bellaria Hospital, Bologna:
Lung cancer
Lung nodule
Transbronchial needle aspiration
Transbronchial lung biopsy
Bronchoscopy

Additional relevant MeSH terms:
Multiple Pulmonary Nodules
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases