Phase II study of transesophageal bronchoscopic ultrasound-guided fine needle aspiration (TEBUS-FNA) using an EBUS bronchoscope in the diagnosis of sarcoidosis
Phase 2
- Conditions
- Sarcoidosis
- Registration Number
- JPRN-UMIN000002883
- Lead Sponsor
- agoya Medical Center
- Brief Summary
A total of 62 lymph nodes with the mean shortest diameter of 13.6 mm were examined. Of the 33 patients enrolled, 29 were given a final diagnosis of sarcoidosis. Four of the residual patients had other diseases (1 lung cancer, 1 tuberculosis, 2 non-specific lymphadenitis). Transesophageal bronchoscopic ultrasound-guided fine needle aspiration showed noncaseating epithelioid cell granulomas in 25 of 29 patients (86%; 95% confidence interval, 73%-100%) with the final diagnosis of sarcoidosis. No complications were observed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
Not provided
Exclusion Criteria
1. Serious concomitant medical illness 2. SPO2<90% with supplemental oxygen 3. Obvious bleeding tendency 4. Pregnancy 5. Other clinical difficulties in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Sensitivity of pathological diagnosis of sarcoidosis
- Secondary Outcome Measures
Name Time Method 1. Time of procedure 2. Sensitivity: according to lymph node location, cytology or histology, stage I or II 3. Frequency of adverse effects 4. Feasibility