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CEUS- versus US- and CT-guided Biopsy for Subpleural Lung Lesions: A Prospective, Multicenter Randomized Controlled
Ke Bi1, Meng-Jun Shen1, Dong Xu2
1Department of Ultrasound, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, China.
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 <0.001) , as well as the highest diagnostic sensitivity (CEUS: 86.1%[714/829] vs. CT: 74.3%[615/828] vs. US: 68.7%[569/828], χ2=72.623, P <0.001). For disease-specific analysis, CEUS yielded superior diagnostic sensitivity for malignant subtypes (CEUS: 91.8%[563/613] vs. CT: 83.2%[520/625] vs. US: 75.2%[479/637], χ2=62.259, P <0.001) and specific benign disorders (CEUS: 69.9%[151/216] vs. CT: 46.8%[95/203] vs. US: 47.1%[90/191], χ2=29.712, P <0.001). Furthermore, the CEUS group exhibited the lowest overall complication rate (CEUS: 4.6%[38/828] vs. US: 7.5%[60/802] vs. CT: 15.8%[127/805], χ2=65.322, P <0.001).
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.