Clinical trial NCT00915330: Rapid On-site Cytopathologic Evaluation in the Diagnosis of Hilar/Mediastinal Adenopathy
Official title: Transbronchial Needle Aspiration With and Without Rapid On-site Cytopathologic Evaluation in the Diagnostic Approach to Hilar/Mediastinal Adenopathy: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Sarcoidosis
Tuberculosis
Keywords: Transbronchial needle aspiration
Bronchoscopy
Rapid on-site cytopathologic evaluation
Mediastinal lymphadenopathy
Hilar Lymphadenopathy
Lead sponsor: Maggiore Bellaria Hospital, Bologna
Sponsor class: OTHER
First posted: 2009-06-08
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether rapid on-site cytopathologic evaluation (ROSE) can increase the diagnostic yield of transbronchial needle aspiration (TBNA) in the diagnosis of hilar and mediastinal lymphadenopathy.


Eligibility criteria: 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

Primary outcomes:
measure: Examine the diagnostic yield of the TBNA with ROSE arm versus the diagnostic yield of TBNA alone arm
timeFrame: 6-12 months
Secondary outcomes:
measure: Examine the percentage of inadequate samples in the TBNA with ROSE arm versus the TBNA alone arm
timeFrame: 6-12 months
measure: Examine the number of biopsy sites in the TBNA with ROSE arm versus the TBNA alone arm
timeFrame: 6-12 months
measure: Examine the complication rate of bronchoscopy in the TBNA with ROSE arm versus the TBNA alone arm
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Maggiore Hospital
Study officials:
affiliation: Maggiore Hospital
name: Marco Patelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diacon AH, Schuurmans MM, Theron J, Louw M, Wright CA, Brundyn K, Bolliger CT. Utility of rapid on-site evaluation of transbronchial needle aspirates. Respiration. 2005 Mar-Apr;72(2):182-8. doi: 10.1159/000084050.
citation: Davenport RD. Rapid on-site evaluation of transbronchial aspirates. Chest. 1990 Jul;98(1):59-61. doi: 10.1378/chest.98.1.59.
citation: Baram D, Garcia RB, Richman PS. Impact of rapid on-site cytologic evaluation during transbronchial needle aspiration. Chest. 2005 Aug;128(2):869-75. doi: 10.1378/chest.128.2.869.
citation: Diette GB, White P Jr, Terry P, Jenckes M, Rosenthal D, Rubin HR. Utility of on-site cytopathology assessment for bronchoscopic evaluation of lung masses and adenopathy. Chest. 2000 Apr;117(4):1186-90. doi: 10.1378/chest.117.4.1186.
citation: Trisolini R, Cancellieri A, Tinelli C, Paioli D, Scudeller L, Casadei GP, Forti Parri S, Livi V, Bondi A, Boaron M, Patelli M. Rapid on-site evaluation of transbronchial aspirates in the diagnosis of hilar and mediastinal adenopathy: a randomized trial. Chest. 2011 Feb;139(2):395-401. doi: 10.1378/chest.10-1521. Epub 2010 Oct 28.