Randomized study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) with vs. without rapid on-site cytologic evaluation (ROSE) in the diagnosis of lung cancer
- Conditions
- ung cancer
- Registration Number
- JPRN-UMIN000001334
- Lead Sponsor
- agoya Medical Center
- Brief Summary
Twelve patients with visible endobronchial lesions were excluded in the analysis. Thus, a total of 108 patients (55 in ROSE group; 53 in non-ROSE group) were analyzed. Additional procedures including EBUS-TBNA for lesions other than the main target lesion and/or transbronchial biopsy in the same setting were performed in 11% of patients in the ROSE group and 57% in the non-ROSE group (p < 0.001). Mean puncture number was significantly fewer in the ROSE group (2.2 vs. 3.1 punctures, p < 0.001). Mean bronchoscopy time was similar between both groups (22.3 vs. 22.1 min, p = 0.95). The sensitivity and accuracy for diagnosing lung cancer were 88% and 89% in the ROSE group, and 86% and 89% in the non-ROSE group, respectively. No complications were associated with the procedures.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 120
Not provided
1. Patients with known lung cancer (e.g., mediastinal staging purposes) 2. Endobronchial lesions 3. Patients with severe concomitant medical illness 4. Bleeding tendency 5. Pregnant woman 6. Other clinical difficulties in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Yields for eliminating the need for additional bronchoscopic procedures
- Secondary Outcome Measures
Name Time Method 1. Diagnostic yields (EBUS-TBNA, overall bronchoscopy) 2. Accuracy of EBUS-TBNA 3. Number of needle passes 4. Time of procedure (EBUS-TBNA, overall bronchoscopy) 5. Accuracy of ROSE 6. Frequency of adverse effects