Rapid On-site Cytopathologic Evaluation in the Diagnosis of Hilar/Mediastinal Adenopathy

Transbronchial Needle Aspiration With and Without Rapid On-site Cytopathologic Evaluation in the Diagnostic Approach to Hilar/Mediastinal Adenopathy: A Randomized Controlled Trial.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00915330

Enrollment

164

Registered

2009-06-08

Start date

2009-05-31

Completion date

2010-02-28

Last updated

2010-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Sarcoidosis, Tuberculosis

Keywords

Transbronchial needle aspiration, Bronchoscopy, Rapid on-site cytopathologic evaluation, Mediastinal lymphadenopathy, Hilar Lymphadenopathy

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.

Interventions

PROCEDURERapid on-site cytopathologic evaluation (ROSE)

ROSE: examination in the endoscopy suite, by a pathologist, during the bronchoscopic procedure, of samples obtained with transbronchial needle aspiration.

PROCEDURETBNA

transbronchial needle aspiration

Study design

Allocation

RANDOMIZED

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Examine the diagnostic yield of the TBNA with ROSE arm versus the diagnostic yield of TBNA alone arm	6-12 months

Secondary

Measure	Time frame
Examine the percentage of inadequate samples in the TBNA with ROSE arm versus the TBNA alone arm	6-12 months
Examine the number of biopsy sites in the TBNA with ROSE arm versus the TBNA alone arm	6-12 months
Examine the complication rate of bronchoscopy in the TBNA with ROSE arm versus the TBNA alone arm	6-12 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026