Ultrasonic Elastography-guided Pleural Biopsy versus Traditional Thoracic Ultrasound-guided Pleural Biopsy for the Diagnosis of Pleural Effusion: A Multicentre Randomized Trial.
{"title":"Ultrasonic Elastography-guided Pleural Biopsy versus Traditional Thoracic Ultrasound-guided Pleural Biopsy for the Diagnosis of Pleural Effusion: A Multicentre Randomized Trial.","authors":"Mingming Deng,Yang Xia,Xianwei Ye,Jiangwei Ma,Shuai Zhao,Qin Zhang,Jia Li,Jieru Lin,Anwei Jing,Zi-Yao Li,Bin Jiang,Jie Wu,Qing Wen,Jiaojiao Ma,Run Tong,Ziwen Zheng,Weidong Xu,Xuelian Li,Felix Jf Herth,Gang Hou","doi":"10.1183/13993003.01062-2025","DOIUrl":null,"url":null,"abstract":"BACKGROUND\r\nTraditional 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.\r\n\r\nMETHODS\r\nIn this multicentre, randomised trial (ClinicalTrials.gov ID: NCT05781659), patients with pleural effusion of unknown origin were enrolled and randomized (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.\r\n\r\nFINDINGS\r\nIn 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 that 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 did (87.83% [101/115] versus 76.99% [87/113], p=0.032). For patients with MPE and a pleural thickness ≤5 mm without who did not have pleural nodules, UEPB had a significantly greater sensitivity than did 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 (6.36% versus 8.33%, p=0.552).\r\n\r\nINTERPRETATION\r\nUEPB was superior to TUSPB in the diagnosis of MPE with a similar safety profile.","PeriodicalId":12265,"journal":{"name":"European Respiratory Journal","volume":"106 1","pages":""},"PeriodicalIF":21.0000,"publicationDate":"2025-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Respiratory Journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1183/13993003.01062-2025","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"RESPIRATORY SYSTEM","Score":null,"Total":0}
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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 ID: NCT05781659), patients with pleural effusion of unknown origin were enrolled and randomized (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.
FINDINGS
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 that 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 did (87.83% [101/115] versus 76.99% [87/113], p=0.032). For patients with MPE and a pleural thickness ≤5 mm without who did not have pleural nodules, UEPB had a significantly greater sensitivity than did 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 (6.36% versus 8.33%, p=0.552).
INTERPRETATION
UEPB was superior to TUSPB in the diagnosis of MPE with a similar safety profile.
期刊介绍:
The European Respiratory Journal (ERJ) is the flagship journal of the European Respiratory Society. It has a current impact factor of 24.9. The journal covers various aspects of adult and paediatric respiratory medicine, including cell biology, epidemiology, immunology, oncology, pathophysiology, imaging, occupational medicine, intensive care, sleep medicine, and thoracic surgery. In addition to original research material, the ERJ publishes editorial commentaries, reviews, short research letters, and correspondence to the editor. The articles are published continuously and collected into 12 monthly issues in two volumes per year.