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

Background Transthoracic shear-wave elastography (SWE) facilitates differentiation between benign and malignant lesions. This pragmatic randomised controlled trial aimed to validate the effectiveness and safety of SWE-guided transthoracic biopsy for diagnosing subpleural lung lesions. 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. Rapid on-site cytological evaluations were performed to guide adjustments to biopsy target areas. The primary outcome was the diagnostic yield, defined as the proportion of biopsies yielding a specific benign or malignant diagnosis on cytology or histology. Secondary outcomes included biopsy duration and the combined incidence of post-biopsy complications. Results From May 2019 to June 2023, a total of 413 patients were randomised. Ultimately, 205 patients in the SWE group and 206 in the conventional group were included in the intention-to-diagnose analysis. 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). The combined incidence of 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). Conclusions SWE-guided transthoracic biopsy increased the diagnostic yield and reduced the biopsy duration for subpleural lung lesions without increasing the risk of complications.