Transbronchial Needle Aspiration in the Diagnosis of Peripheral Pulmonary Malignancy

This study has been completed.

Sponsor:

Information provided by:

Maggiore Bellaria Hospital, Bologna

ClinicalTrials.gov Identifier:

NCT00917137

First received: June 9, 2009

Last updated: June 22, 2010

Last verified: June 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	June 9, 2009
Last Updated Date	June 22, 2010
Start Date ^ICMJE	July 2008
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 9, 2009)	Assess sensitivity, specificity and accuracy of TBNA in the diagnosis of peripheral pulmonary lesions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00917137 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 9, 2009)	Evaluate the predictor variables associated with a positive TBNA result [ Time Frame: 1 year ] [ Designated as safety issue: No ] Compare the performance characteristics of TBNA and transbronchial lung biopsy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Transbronchial Needle Aspiration in the Diagnosis of Peripheral Pulmonary Malignancy
Official Title ^ICMJE	Transbronchial Needle Aspiration in the Diagnosis of Peripheral Pulmonary Malignancy: Yield and Predictors of a Positive Aspirate
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 Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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)
Condition ^ICMJE	Pulmonary Nodule Pulmonary Mass
Intervention ^ICMJE	Procedure: TBNA + transbronchial lung biopsy + bronchial washing
Study Group/Cohort (s)	Peripheral pulmonary lesions Intervention: Procedure: TBNA + transbronchial lung biopsy + bronchial washing
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	200
Completion Date	June 2010
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 76 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT00917137
Other Study ID Numbers ^ICMJE	02-Trisolini
Has Data Monitoring Committee	No
Responsible Party	Marco Patelli, Maggiore Bellaria Hospital
Study Sponsor ^ICMJE	Maggiore Bellaria Hospital, Bologna
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Maggiore Bellaria Hospital, Bologna
Verification Date	June 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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