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

Not Applicable

Completed

• Conditions: Lung Cancer; Sarcoidosis; Tuberculosis

• Registration Number: NCT00915330
• Lead Sponsor: Maggiore Bellaria Hospital, Bologna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-04
• Study First Submitted QC: 2009-06-05
• Study First Posted: 2009-06-08
• Status Verified: 2010-02
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Last Update Submitted: 2010-02-18
• Last Update Posted: 2010-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Maggiore Hospital; 🇮🇹 Bologna, Italy