Abstract
Background
Ultrasound (US)-guided percutaneous lung needle biopsy (PLNB), the guideline-recommended approach for subpleural lung lesion (SLL) diagnosis, requires comparison with CT-guided biopsy based on high-level evidence clinical studies.Research question
Is US-guided PLNB superior to CT-guided biopsy in diagnostic performance and safety, and does CEUS provide further advantages?Study design and methods
Participants undergoing PLNB for SLLs between June 2020 and November 2023 were randomized to US-, CEUS- and CT-guided biopsies. The dual primary outcomes were diagnostic yield and disease-specific diagnostic sensitivity. Diagnostic yield was defined according to the strict ATS/ACCP definition as the proportion of biopsies yielding clinically actionable diagnoses, while sensitivity referred to the proportion of patients with a confirmed disease correctly identified by biopsy. Four secondary outcomes included complication rate, CNB/FNA utilization, puncture number, and puncture time, with the overall complication rate adopted as the key safety indicator.Results
A total of 2485 participants were randomized into the US (n=828), CEUS (n=829) and CT (n=828) groups. The CEUS-guided biopsy achieved the highest diagnostic yield (CEUS: 88.8%[736/829] vs. CT: 78.9%[653/828] vs. US: 76.0%[629/828], χ2=49.046, P 2=72.623, P 2=62.259, P 2=29.712, P 2=65.322, P Interpretation
For SLL biopsy, CEUS-guided PLNB outperforms US- and CT-guided approaches in both diagnostic performance and procedural safety. CEUS guidance notably improves disease-specific diagnostic sensitivity for malignant subtypes and specific benign pulmonary disorders, serving as an optimal technique for clinical percutaneous lung biopsy.Clinical trial registration
Chinese Clinical Trial Registry; No.: ChiCTR2100045374; URL: www.chictr.org.cn.