ArticleRespiratory research2026
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.
Article in Respiratory research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07419620 (Ultrasounic Elastography-guided Pleural Biopsy Followed by As-needed Medical Thoracoscopic Pleural Biopsy Versus Immediate Medical Thoracoscopic Pleural Biopsy for the Diagnosis of Pleural Effusion), which is not on this map. Not yet cited in PubMed.
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Ultrasounic Elastography-guided Pleural Biopsy Followed by As-needed Medical Thoracoscopic Pleural Biopsy Versus Immediate Medical Thoracoscopic Pleural Biopsy for the Diagnosis of Pleural Effusion
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Abstract
introductionExudative 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 registrationClinicalTrials.gov (Registration ID: NCT07419620; Registration Date: 2026-02-12).
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