A phase II study of real-time endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) with rapid on-site cytologic evaluation (ROSE) in the diagnosis of lung cancer
Phase 2
- Conditions
- ung cancer
- Registration Number
- JPRN-UMIN000000506
- Lead Sponsor
- agoya Medical Center
- Brief Summary
EBUS-TBNA with ROSE for hilar-mediastinal lesions established a specific diagnosis in 63 of all 81 patients (78%) examined, and in 55 of 64 (86%) in whom lung cancer was diagnosed without any complications. The ROSE results allowed the avoidance of additional bronchoscopic procedures in 53 of 81 patients (65%). Although four false-positive results and two false-negative results (accuracy; 93%) occurred in predicting the final diagnosis of malignancy by ROSE on EBUS-TBNA, the misdiagnosis by ROSE did not cause any significant adverse effects on patient care.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
Not provided
Exclusion Criteria
1. Patients with known lung cancer 2. Pregnancy 3. Other clinical difficulties in this study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic yield
- Secondary Outcome Measures
Name Time Method 1. Frequency of adverse effects 2. The accuracy of EBUS-TBNA for diagnosing malignancy 3. The accuracy of ROSE for predicting final diagnosis of malignancy