Ultrasonic elastography-guided pleural biopsy versus traditional thoracic ultrasound-guided pleural biopsy for the diagnosis of pleural effusion: a multicentre, randomised trial.

Ultrasound elastography can be used to differentiate MPE from benign diseases by evaluating pleural stiffness.

超声弹性成像可用于通过评估胸膜硬度来区分MPE和良性疾病。

This study aimed to investigate whether ultrasonic elastography-guided pleural biopsy (UEPB) offers diagnostic accuracy superior to that of TUSPB for pleural effusions.

本研究旨在调查超声弹性成像引导的胸膜活检（UEPB）是否比TUSPB对胸腔积液的诊断准确性更高。

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.

在这项多中心、随机试验（ClinicalTrials.gov: NCT05781659）中，对原因不明的胸腔积液患者进行了招募，并按1:1的比例随机分配接受UEPB或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.

主要测量的终点是UEPB在诊断MPE中的敏感性；次要终点是两种方法在不同胸膜厚度患者中的诊断率以及UEPB的安全性。

Results

In total, 232 patients with pleural effusion were enrolled, 228 of whom were included in the analysis.

共有232名胸腔积液患者被纳入研究，其中228名患者被纳入分析。

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).

在UEPB组中检测MPE的敏感性显著高于TUSPB组（85.00% (51/60) 对比 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).

UEPB组的诊断效率显著高于TUSPB组（87.83% (101/115) 对比 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).

对于胸膜厚度≤5毫米且没有胸膜结节的恶性胸腔积液患者，超声引导下经皮胸膜活检（UEPB）的敏感性显著高于超声定位下经皮胸膜活检（TUSPB）（80.49% (33/41) 对比 50.00% (15/30); p=0.007）。

The rates of procedure-related complications were similar between the UEPB and TUSPB groups (6.36% versus 8.33%; p=0.552).

UEPB组和TUSPB组的与操作相关的并发症发生率相似（6.36% 对比 8.33%; p=0.552）。

Conclusions

UEPB was superior to TUSPB in the diagnosis of MPE with a similar safety profile.

UEPB在诊断恶性胸腔积液（MPE）方面优于TUSPB，并且具有相似的安全性剖面。