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

June 9, 2009
June 22, 2010
July 2008
June 2010   (final data collection date for primary outcome measure)
Assess sensitivity, specificity and accuracy of TBNA in the diagnosis of peripheral pulmonary lesions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00917137 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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

  • Pulmonary Nodule
  • Pulmonary Mass
Procedure: TBNA + transbronchial lung biopsy + bronchial washing
Peripheral pulmonary lesions
Intervention: Procedure: TBNA + transbronchial lung biopsy + bronchial washing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 76 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00917137
02-Trisolini
No
Marco Patelli, Maggiore Bellaria Hospital
Maggiore Bellaria Hospital, Bologna
Not Provided
Not Provided
Maggiore Bellaria Hospital, Bologna
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP