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

IF 9.8 1区医学 Q1 CRITICAL CARE MEDICINE Chest Pub Date : 2026-10-03 DOI:10.1016/j.chest.2026.09.089

Ke Bi, Meng-Jun Shen, Dong Xu, Qing Tang, Yi-Xue Sun, Xiao-Fei Ye, Yi Zhang, Yang Cong, Hui-Ming Zhu, Hong-Wei Chen, Chun-Hong Tang, Yin Wang

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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 <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.

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超声造影与超声和ct引导下胸膜下肺病变活检：一项前瞻性、多中心随机对照试验。

背景：超声（US）引导下的经皮肺穿刺活检（PLNB）是胸膜下肺病变（SLL）诊断的指南推荐方法，需要基于高水平证据的临床研究与ct引导下的活检进行比较。研究问题：us引导下的PLNB在诊断性能和安全性上是否优于ct引导下的活检，超声造影是否有进一步的优势？研究设计和方法：在2020年6月至2023年11月期间接受sll PLNB的参与者被随机分配到US、CEUS和ct引导下的活检中。两个主要结局是诊断率和疾病特异性诊断敏感性。诊断产率根据严格的ATS/ACCP定义定义为活检产生临床可操作诊断的比例，而敏感性是指活检正确识别确诊疾病的患者比例。4个次要指标包括并发症发生率、CNB/FNA使用率、穿刺次数和穿刺时间，以总并发症发生率作为主要安全性指标。结果：共有2485名参与者被随机分为US组（n=828）、CEUS组（n=829）和CT组（n=828）。超声引导下活检的诊断率最高(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解释：对于SLL活检，超声引导下PLNB在诊断性能和手术安全性方面都优于超声和CT引导下的方法。超声造影指导可显著提高对恶性亚型和特定良性肺疾病的疾病特异性诊断敏感性，是临床经皮肺活检的最佳技术。临床试验注册：Chinese Clinical trial Registry；否。: ChiCTR2100045374;URL: www.chictr.org.cn。

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来源期刊

Chest 医学-呼吸系统

CiteScore

13.70

自引率

3.10%

发文量

3369

审稿时长

15 days

期刊介绍： At CHEST, our mission is to revolutionize patient care through the collaboration of multidisciplinary clinicians in the fields of pulmonary, critical care, and sleep medicine. We achieve this by publishing cutting-edge clinical research that addresses current challenges and brings forth future advancements. To enhance understanding in a rapidly evolving field, CHEST also features review articles, commentaries, and facilitates discussions on emerging controversies. We place great emphasis on scientific rigor, employing a rigorous peer review process, and ensuring all accepted content is published online within two weeks.