Trial Information
Transbronchial Needle Aspiration With and Without Rapid On-site Cytopathologic Evaluation in the Diagnostic Approach to Hilar/Mediastinal Adenopathy: A Randomized Controlled Trial.
Inclusion Criteria:
- 18 years old and older
- Hilar and/or mediastinal lymphadenopathy (> 1 cm on the short axis, as assessed by
contrast-enhanced CT scan (computed tomography))
Exclusion Criteria:
- Uncontrolled coagulopathy
- Refusal to sign informed consent
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Examine the diagnostic yield of the TBNA with ROSE arm versus the diagnostic yield of TBNA alone arm
Outcome Time Frame:
6-12 months
Safety Issue:
No
Principal Investigator
Marco Patelli, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Maggiore Hospital
Authority:
Italy: Ethics Committee
Study ID:
01-Trisolini
NCT ID:
NCT00915330
Start Date:
May 2009
Completion Date:
February 2010
Related Keywords:
- Lung Cancer
- Sarcoidosis
- Tuberculosis
- Transbronchial needle aspiration
- Bronchoscopy
- Rapid on-site cytopathologic evaluation
- Mediastinal lymphadenopathy
- Hilar Lymphadenopathy
- Lung Neoplasms
- Sarcoidosis
- Tuberculosis