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Completed

NCT Number: NCT00917137

Transbronchial Needle Aspiration in the Diagnosis of Peripheral Pulmonary Malignancy

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.

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Key information

Conditions

Pulmonary Nodule Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pulmonary Mass Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Maggiore Hospital

Bologna, 40133, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TBNA + transbronchial lung biopsy + bronchial washing

Procedure

Primary outcomes

  1. Assess sensitivity, specificity and accuracy of TBNA in the diagnosis of peripheral pulmonary lesions

    Time frame: 1 year

Secondary outcomes

  1. Evaluate the predictor variables associated with a positive TBNA result

    Time frame: 1 year

  2. Compare the performance characteristics of TBNA and transbronchial lung biopsy

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Maggiore Bellaria Hospital, Bologna

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 10, 2009
Registry last updated
Jun 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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