Cryobiopsy raised diagnostic yield for peripheral lung lesions, with more bleeding

Design

International, open-label, parallel-group randomised trial in six centres

Population

627 patients with peripheral pulmonary lesions of 30 mm or less visualised on radial EBUS

Primary outcome

Histology-based diagnostic yield

Effect

83% vs 75% overall (difference 8.9%, 95% CI 2.8 to 15.0); moderate bleeding 38% vs 19%

Cryo-RCT randomised 627 patients with peripheral pulmonary lesions of up to 30 mm, visualised with radial endobronchial ultrasound, at six centres in Japan, Malaysia, South Korea and Taiwan. Patients had stand-alone cryobiopsy (one to three specimens) or conventional sampling with forceps, needles or both (five or more specimens where possible). The trial was open-label.

Histology-based diagnostic yield was 83% (262 of 314) with cryobiopsy and 75% (233 of 311) with conventional sampling, a difference of 8.9 percentage points (95% CI 2.8 to 15.0). In the adjacent-to or eccentric cohort, the yield was 77% against 65% (difference 12.4 points, 2.8 to 22.0).

Moderate bleeding was more frequent with cryobiopsy (38% against 19%), and pneumothorax occurred in 2% against under 1%, with chest drains needed in five patients and none. Severe bleeding was rare in both groups and serious adverse events were similar. Cryobiopsy therefore buys yield with more manageable bleeding, and the operators' experience with it matters.

• Consider cryobiopsy in centres with experience when the lesion is adjacent to or eccentric to the radial probe
• Prepare for moderate bleeding, with a plan for airway control and bleeding management
• Inform patients about the higher pneumothorax rate and the possible need for a drain
• Single-use probes add cost, so weigh the yield gain against resources

Why it matters

A diagnostic procedure that misses a quarter of lesions leads to repeat biopsies and delayed treatment.

Don't overread it

The trial measured diagnostic yield, not patient outcomes, and the operators were experienced bronchoscopists at specialist centres.

The statistics, in plain English

An 8.9-point yield difference means about 9 more definitive histological diagnoses per 100 procedures. Open-label trials can be affected by operator behaviour, and the primary analysis excluded two patients after randomisation. The trial did not test whether higher yield changes survival.

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