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Introduction <p>Exudative pleural effusion of an unclear aetiology remains a diagnostic challenge. Ultrasonic elastography-guided pleural biopsy (UEPB) offers a higher diagnostic yield than conventional ultrasound-guided pleural biopsy; however, its role relative to semi-rigid thoracoscopy remains unclear. This trial is designed to determine whether UEPB is non‑inferior to semi-rigid thoracoscopy in diagnostic yield when used as the initial diagnostic procedure, and to further quantify the proportion of patients in whom semi-rigid thoracoscopy could be avoided by adopting a UEPB-first diagnostic strategy.</p> Methods and analysis <p>In this multicentre, open-label, parallel-group, non-inferiority, randomised controlled trial conducted at five sites in China, 420 patients with exudative pleural effusion of unknown aetiology and negative cytology will be randomly assigned 1:1 to either initial UEPB (with semi-rigid thoracoscopy reserved for non-diagnostic cases) or immediate semi-rigid thoracoscopy. The primary outcome is the overall diagnostic yield of the allocated diagnostic strategy, defined as the proportion of participants in whom a specific histopathological diagnosis is stablished through the protocol-defined biopsy procedures within the allocated diagnostic pathway. A non-inferiority margin of − 5% is applied. The secondary outcomes included diagnostic sensitivity in specific disease, procedure-related adverse events, length of hospital stay, duration of chest tube drainage, thoracoscopy avoidance rate, and direct diagnostic pathway-related medical costs.</p> Discussion <p>This UPDATE-3 study will provide the evidence from a RCT directly comparing the a UEPB-first step-up diagnostic strategy with immediate semi-rigid thoracoscopy in patients with undiagnosed exudative pleural effusion. Should non-inferiority be established, UEPB will be validated as a sufficiently sensitive first-line biopsy technique. Furthermore, this trial will quantify the extent to which a UEPB-first strategy can safely decrease the necessity for semi-rigid thoracoscopy and optimize healthcare utilization. These findings could facilitate a paradigm shift towards a less invasive, step-up diagnostic pathway. Conversely, should non-inferiority not be established, the findings will reinforce the status of semi-rigid thoracoscopy as the diagnostic reference standard and elucidate the appropriate role of UEPB within the diagnostic algorithm.</p> Trial registration <p>ClinicalTrials.gov (Registration ID: NCT07419620; Registration Date: 2026-02-12).</p>

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Ultrasonic elastography-guided pleural biopsy followed by as-needed semi-rigid thoracoscopic pleural biopsy versus immediate semi-rigid thoracoscopic pleural biopsy for the diagnosis of pleural effusion (UPDATE-3): a protocol of randomised controlled trial

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  • 发表日期：

    2026年6月20日

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  • Liwei Liao,
  • Jiangwei Ma,
  • Jixiang Ni,
  • Jieru Lin,
  • Shuai Zhao,
  • Yang Xia,
  • Xiaoping Liu,
  • Mingming Deng,
  • Ziwen Zheng,
  • Gang Hou

摘要

Introduction

Exudative pleural effusion of an unclear aetiology remains a diagnostic challenge. Ultrasonic elastography-guided pleural biopsy (UEPB) offers a higher diagnostic yield than conventional ultrasound-guided pleural biopsy; however, its role relative to semi-rigid thoracoscopy remains unclear. This trial is designed to determine whether UEPB is non‑inferior to semi-rigid thoracoscopy in diagnostic yield when used as the initial diagnostic procedure, and to further quantify the proportion of patients in whom semi-rigid thoracoscopy could be avoided by adopting a UEPB-first diagnostic strategy.

Methods and analysis

In this multicentre, open-label, parallel-group, non-inferiority, randomised controlled trial conducted at five sites in China, 420 patients with exudative pleural effusion of unknown aetiology and negative cytology will be randomly assigned 1:1 to either initial UEPB (with semi-rigid thoracoscopy reserved for non-diagnostic cases) or immediate semi-rigid thoracoscopy. The primary outcome is the overall diagnostic yield of the allocated diagnostic strategy, defined as the proportion of participants in whom a specific histopathological diagnosis is stablished through the protocol-defined biopsy procedures within the allocated diagnostic pathway. A non-inferiority margin of − 5% is applied. The secondary outcomes included diagnostic sensitivity in specific disease, procedure-related adverse events, length of hospital stay, duration of chest tube drainage, thoracoscopy avoidance rate, and direct diagnostic pathway-related medical costs.

Discussion

This UPDATE-3 study will provide the evidence from a RCT directly comparing the a UEPB-first step-up diagnostic strategy with immediate semi-rigid thoracoscopy in patients with undiagnosed exudative pleural effusion. Should non-inferiority be established, UEPB will be validated as a sufficiently sensitive first-line biopsy technique. Furthermore, this trial will quantify the extent to which a UEPB-first strategy can safely decrease the necessity for semi-rigid thoracoscopy and optimize healthcare utilization. These findings could facilitate a paradigm shift towards a less invasive, step-up diagnostic pathway. Conversely, should non-inferiority not be established, the findings will reinforce the status of semi-rigid thoracoscopy as the diagnostic reference standard and elucidate the appropriate role of UEPB within the diagnostic algorithm.

Trial registration

ClinicalTrials.gov (Registration ID: NCT07419620; Registration Date: 2026-02-12).