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

Maggiore Bellaria Hospital, Bologna

Status: Completed

Conditions: Sarcoidosis; Tuberculosis; Lung Cancer

Treatments: Procedure: TBNA; Procedure: Rapid on-site cytopathologic evaluation (ROSE)

Study type: Interventional

Funder types: Other

Identifiers

NCT00915330

01-Trisolini

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

164 participants in 2 patient groups

TBNA alone

Active Comparator group

Description:

Arm A: TBNA alone.

Treatment:

Procedure: TBNA

TBNA with ROSE

Experimental group

Description:

Arm B: TBNA with ROSE.

Treatment:

Procedure: TBNA

Procedure: Rapid on-site cytopathologic evaluation (ROSE)