CEUS- versus US- and CT-guided Biopsy for Subpleural Lung Lesions: A Prospective, Multicenter Randomized Controlled Trial.

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.