This study aims to systematically compare the diagnostic efficacy, specimen quality, and complication rates of the cryobiopsy needle technique(CassiII rotational core biopsy) versus the automated biopsy technique in the biopsy of pulmonary nodules, thereby providing a reliable evidentiary basis for clinical practice.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
308
CassiII rotational core biopsy needle is inserted in lesion site, ≥1 biopsy is performed.
Automated biopsy needle is inserted in lesion site, ≥1 biopsy is performed.
Beijing Chaoyang Hospital
Beijing, Chaoyang, China
Diagnostic yield of the two biopsy methods
Diagnostic yield = (Number of pathologically positive cases / Total number of enrolled cases) × 100%
Time frame: From enrollment to the end of procedure at 2 years
Specimen size
biopsy tissue size (long diameter, millimeter)
Time frame: From enrollment to the end of procedure at 2 years
Consistency analysis between AI-ROSE results and pathological results
The results of AI-ROSE were compared with the pathological results, and the consistency analysis was performed to evaluate the effectiveness of AI-ROSE
Time frame: From enrollment to the end of procedure at 2 years
Safety indicators
Complications: Incidence (including pneumothorax, hemorrhage, respiratory failure, infection, and severe complications requiring endotracheal intubation and mechanical ventilation to be transferred to the Intensive Care Unit), severity levels, and corresponding management measures.
Time frame: From enrollment to the end of procedure at 2 years
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