- Design
- International, open-label, parallel-group RCT
- Population
- 627 patients with peripheral lung lesions ≤30 mm on radial EBUS
- Primary outcome
- Histology-based diagnostic yield
- Effect
- Eccentric lesions 77% vs 65% (difference 12.4%, 2.8–22.0); overall 83% vs 75%
The Cryo-RCT, published in July, randomised 627 patients with peripheral lung lesions of 30 mm or less, visualised by radial endobronchial ultrasound at six centres in Japan, Malaysia, South Korea and Taiwan, to stand-alone cryobiopsy with a single-use cryoprobe or conventional sampling with forceps or needles.
Where the probe sat adjacent to or eccentric to the lesion — the harder cases — histological diagnostic yield was 77% with cryobiopsy and 65% with conventional sampling. Overall, it was 83% against 75%. Moderate bleeding was twice as common with cryobiopsy (38% vs 19%), and pneumothorax was more frequent (2% vs under 1%), with five patients needing a chest drain. Severe bleeding and serious adverse events were rare in both groups.
The trial supports cryobiopsy for peripheral lesions in experienced hands, particularly when the radial probe view is eccentric. Teams adopting it need to be ready to manage bleeding.
- Consider cryobiopsy for peripheral lesions, especially when the radial probe view is eccentric or adjacent.
- Prepare for more moderate bleeding, including balloon blockers and cold saline.
- Warn patients about a small increase in pneumothorax risk.
- Use cryobiopsy where the team has training and equipment for it.
Why it matters
Higher yield at first bronchoscopy can spare patients repeat procedures and diagnostic delay.
Don't overread it
The trial was open-label in experienced Asian centres; yield and complication rates may differ elsewhere.
The statistics, in plain English
A 12.4-point difference in yield (95% CI 2.8 to 22.0) in harder lesions means roughly one extra diagnosis for every eight patients sampled with cryobiopsy.
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