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

Maggiore Bellaria Hospital, Bologna164 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

164

Conditions

Lung Cancer Sarcoidosis Tuberculosis

Interventions

Rapid on-site cytopathologic evaluation (ROSE)PROCEDURE

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

TBNAPROCEDURE

transbronchial needle aspiration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Maggiore Hospital

Bologna, Italy

Outcomes

Primary Outcomes

Examine the diagnostic yield of the TBNA with ROSE arm versus the diagnostic yield of TBNA alone arm

Time frame: 6-12 months

Secondary Outcomes

Examine the percentage of inadequate samples in the TBNA with ROSE arm versus the TBNA alone arm

Time frame: 6-12 months

Examine the number of biopsy sites in the TBNA with ROSE arm versus the TBNA alone arm

Time frame: 6-12 months

Examine the complication rate of bronchoscopy in the TBNA with ROSE arm versus the TBNA alone arm

Time frame: 6-12 months

Data from ClinicalTrials.gov

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