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Published on: July 19, 2024
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Study protocol for a randomized trial comparing cryobiopsy and conventional biopsy for peripheral pulmonary lesions
Yuji Matsumoto1, Tatsuya Imabayashi2, Toshiyuki Nakai3
1Department of Endoscopy, Respiratory Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan; Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Respiratory Investigation
|April 19, 2025
Summary
This study compares cryobiopsy to conventional biopsy for diagnosing peripheral pulmonary lesions using radial endobronchial ultrasound (R-EBUS). Results will clarify which biopsy method offers superior diagnostic performance in bronchoscopy for PPLs.
Area of Science:
- Pulmonology
- Interventional Pulmonology
- Diagnostic Bronchoscopy
Background:
- Radial endobronchial ultrasound (R-EBUS) and navigation enhance bronchoscopy for peripheral pulmonary lesions (PPLs).
- Single-use cryoprobes show promise for increasing diagnostic yield in PPLs.
- This study directly compares cryobiopsy with conventional biopsy for PPL diagnosis.
Purpose of the Study:
- To compare the diagnostic performance of cryobiopsy versus conventional biopsy in bronchoscopy for PPLs.
- To evaluate differences in diagnostic value and safety between cryobiopsy and conventional biopsy.
- To explore patient subgroups benefiting most from cryobiopsy.
Main Methods:
- Multicenter randomized controlled trial enrolling 660 patients with PPLs ≤30 mm.
- Patients undergo bronchoscopy with R-EBUS; those with reachable lesions are randomized to conventional biopsy (forceps/aspiration needles) or single-use cryoprobe biopsy.
- Primary endpoint: histology-based diagnostic yield; secondary endpoints: diagnostic value and safety.
Main Results:
- This section will report the primary endpoint comparing histology-based diagnostic yield between cryobiopsy and conventional biopsy groups.
- Subgroup analyses will identify patient populations where cryobiopsy is most effective.
- Secondary endpoints will detail differences in diagnostic value and safety profiles.
Conclusions:
- This is the first study to directly evaluate the efficacy of cryobiopsy versus conventional biopsy for PPL diagnosis via bronchoscopy.
- The findings will elucidate the comparative diagnostic performance and safety of these two biopsy techniques.
