EBUS-guided transbronchial mediastinal cryobiopsy for diagnosing non-metastatic lymphadenopathy: A randomized controlled trial.
Summary
In a multicenter randomized trial directly comparing EBUS-TBMC and EBUS-TBNA within the same bronchoscopy session, TBMC achieved a significantly higher diagnostic yield (97.1% vs 79.9%), particularly for sarcoidosis. Safety was acceptable, with only grade 1 airway bleeding reported.
Key Findings
- Overall diagnostic yield was higher with EBUS-TBMC than EBUS-TBNA (97.1% vs 79.9%, p<0.001).
- Sensitivity for sarcoidosis was superior with EBUS-TBMC (98.0% vs 82.7%, p<0.001).
- All adverse events were grade 1 airway bleeding, indicating acceptable safety.
Clinical Implications
EBUS-TBMC may be prioritized in diagnostic algorithms for suspected sarcoidosis or benign lymphadenopathy, with protocols for managing minor bleeding. Training bronchoscopists in cryobiopsy techniques and standardizing sample handling could enhance diagnostic pathways.
Why It Matters
These results support adopting EBUS-TBMC as a first-line diagnostic approach for non-metastatic mediastinal/hilar lymphadenopathy, particularly sarcoidosis. It addresses a long-standing limitation of TBNA for benign etiologies and lymphoma.
Limitations
- Cohort was almost exclusively sarcoidosis, limiting generalizability to diverse benign etiologies and lymphoma subtypes.
- Short-term diagnostic outcomes reported; no long-term follow-up or cost-effectiveness analysis.
Future Directions
Confirm performance and safety across broader benign etiologies (including diverse lymphomas), assess procedural learning curves, and evaluate cost-effectiveness and guideline integration.
Study Information
- Study Type
- RCT
- Research Domain
- Diagnosis
- Evidence Level
- I - Randomized controlled trial directly comparing diagnostic modalities.
- Study Design
- OTHER