Shear-wave elastography-guided transthoracic biopsy for lung lesions: a randomised controlled trial.

This pragmatic randomised controlled trialaimed to validate the effectiveness and safety of SWE-guided transthoracic biopsy for diagnosing subpleural lung lesions.

这项实用的随机对照试验旨在验证SWE引导下的经胸壁活检在诊断胸膜下肺病变方面的有效性和安全性。

Methods

Eligible patients with peripheral lung lesions suspicious for lung malignancy and suitable for biopsy were randomised in a 1:1 ratio to the SWE-guided or conventional ultrasound-guided transthoracic biopsy groups.

符合入组条件的患者，其周围肺部病变疑似为肺恶性肿瘤且适合进行活检，按1:1的比例随机分配到SWE引导或常规超声引导经胸活检组。

Rapid on-site cytological evaluations were performed to guide adjustments to biopsy target areas.

进行了快速现场细胞学评估，以指导对活检目标区域的调整。

The primary outcome was the diagnostic yield, defined as the proportion of biopsies yielding a specific benign or malignant diagnosis on cytology or histology.

主要结果是诊断效率，定义为在细胞学或组织学上获得特定良性或恶性诊断的活检比例。

Secondary outcomes included biopsy duration and the combined incidenceof post-biopsy complications.

次要结果包括活检持续时间和活检后并发症的综合发生率。

Results

From May 2019 to June 2023, a total of 413 patients were randomised.

从2019年5月到2023年6月，共有413名患者被随机分配。

Ultimately, 205 patients in the SWE group and 206 in the conventional group were included in the intention-to-diagnose analysis.

最终，意向诊断分析包括了205名SWE组患者和206名常规治疗组患者。

The SWE group achieved a significantly higher diagnostic yield compared with the conventional group (94.6% versus 88.3%; risk ratio 1.07, 95% CI 1.01-1.14; p=0.02) and a shorter biopsy duration (median (interquartile range) 12 (9-15) versus 13 (10-18) min; Hodges-Lehmann median difference -1.0 (95% CI -3.0-0) min; p=0.003).

SWE组相较于传统组实现了显著更高的诊断效率（94.6%对比88.3%；风险比1.07，95%置信区间1.01-1.14；p=0.02），并且活检时间更短（中位数（四分位数间距）12（9-15）分钟对比13（10-18）分钟；Hodges-Lehmann中位数差异-1.0（95%置信区间-3.0-0）分钟；p=0.003）。

The combined incidenceof pneumothorax, haemoptysis and haemothorax was comparable between the groups (2.4% versus 2.9%; risk ratio 0.84, 95% CI 0.26-2.70; p=0.77).

两组间气胸、咯血和血胸的总发生率相当（2.4%对比2.9%；风险比0.84，95%置信区间0.26-2.70；p=0.77）。

Conclusions

SWE-guided transthoracic biopsy increased the diagnostic yield and reduced the biopsy duration for subpleural lung lesions without increasing the risk of complications.

超声弹性成像引导的经胸肺活检提高了对胸膜下肺病变的诊断效率，并缩短了活检时间，同时没有增加并发症的风险。