Ultrasonic elastography-guided pleural biopsy <i>versus</i> traditional thoracic ultrasound-guided pleural biopsy for the diagnosis of pleural effusion: a multicentre, randomised trial
Mingming Deng, Xia Yang, Xian-Wei Ye, Jiangwei Ma, Shuai Zhao, Qin Zhang, Jia Li, Jieru E. Lin, Anwei Jing, Zi-Yao Li, Bin Jiang, Jie Wu, Qing Wen, Jiaojiao Ma, Run Tong, Ziwen Zheng, Weidong Xu, Xuelian Li, Felix Herth, Gang Hou
Abstract
Background Traditional thoracic ultrasound-guided pleural biopsy (TUSPB) is considered the initial method for histological diagnosis; however, its sensitivity for detecting malignant pleural effusion (MPE) is limited. Ultrasound elastography can be used to differentiate MPE from benign diseases by evaluating pleural stiffness. This study aimed to investigate whether ultrasonic elastography-guided pleural biopsy (UEPB) offers diagnostic accuracy superior to that of TUSPB for pleural effusions. Methods In this multicentre, randomised trial ( ClinicalTrials.gov : NCT05781659 ), patients with pleural effusion of unknown origin were enrolled and randomised (1:1) to undergo either UEPB or TUSPB. The primary outcome measured was the sensitivity of UEPB in diagnosing MPE; the secondary outcomes were the diagnostic rate of the two methods in patients with different pleural thicknesses and the safety of UEPB. Results In total, 232 patients with pleural effusion were enrolled, 228 of whom were included in the analysis. The sensitivity for detecting MPE was significantly greater in the UEPB group than in the TUSPB group (85.00% (51/60) versus 63.16% (36/57); p=0.007). Patients in the UEPB group had a significantly greater diagnostic yield than those in the TUSPB group (87.83% (101/115) versus 76.99% (87/113); p=0.032). For patients with MPE and a pleural thickness ≤5 mm who did not have pleural nodules, UEPB had a significantly greater sensitivity than TUSPB (80.49% (33/41) versus 50.00% (15/30); p=0.007). The rates of procedure-related complications were similar between the UEPB and TUSPB groups (5.22% versus 7.96%; p=0.403). Conclusion UEPB was superior to TUSPB in the diagnosis of MPE with a similar safety profile.