Diagnostic yield and safety of needle-based COnfocaL LAser endomicroscopy and ultrasound-guided pleural BiOpsy in diagnosing patients with unknown pleuRAl effusion: a protocol for a mulTIcenter, randomized cONtrolled trial (COLLABORATION-II)

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dc.contributor.authorZheng, Ziwen
dc.contributor.authorYe, Shenglan
dc.contributor.authorLiu, Xiaoping
dc.contributor.authorXiao, Kui
dc.contributor.authorDeng, Mingming
dc.contributor.authorTong, Run
dc.contributor.authorPorcel Pérez, José
dc.contributor.authorWang, Tao
dc.contributor.authorHou, Gang
dc.date.accessioned2026-07-22T09:26:17Z
dc.date.available2026-07-22T09:26:17Z
dc.date.issued2026
dc.description.abstractBACKGROUND: The diagnosis of exudative pleural effusion is challenging. Although ultrasound-guided pleural biopsy (UGBx) is common, its effectiveness varies, especially in the absence of pleural abnormalities. New imaging techniques have been explored to improve UGBx outcomes, but the results remain inadequate. Recently, needle-based confocal laser endomicroscopy (nCLE) has been used to improve biopsy targeting and diagnostic yield through real-time cellular-level imaging; however, robust evidence is lacking. This trial aims to assess the diagnostic yield and safety of nCLE-assisted UGBx for unknown exudative pleural effusions. METHODS: COLLABORATION-II is a multicenter randomized controlled study in China involving 324 participants across ten centers. Participants will be divided into two groups based on the ultrasound findings: Group 1 with pleural thickening (> 5 mm) and/or pleural nodularity, and Group 2 with thickness ≤ 5 mm and no nodularity. Each group will be randomly assigned to either the nCLE-assisted UGBx or UGBx arm at a 1:1 ratio, with a 12-month follow-up. The primary outcome is the overall diagnostic yield, while secondary outcomes include the biopsy success rate, diagnostic sensitivity for specific diseases, complication in incidence, and specimen characteristics, such as size, quality, interpretability, and adequacy for achieving molecular diagnosis. DISCUSSION: We hypothesize that the nCLE-assisted UGBx will achieve higher diagnostic yield than conventional UGBx by providing real-time, cellular-level visualization and targeted sampling of pathological areas. If this hypothesis is validated, nCLE-assisted UGBx could emerge as a novel and effective option for diagnosing patients with unknown exudative pleural effusion. TRIAL REGISTRATION: This study has been registered at www.clinicaltrials.gov (Registration number: NCT07040241; Registration Date: 2025-06-26).
dc.identifier.doihttps://doi.org/10.1186/s12931-026-03674-7
dc.identifier.issn1465-993X
dc.identifier.issn1465-9921
dc.identifier.urihttps://hdl.handle.net/10459.1/470952
dc.language.isoen
dc.publisherBioMed Central
dc.relation.isformatofReproducció del document publicat a: https://doi.org/10.1186/s12931-026-03674-7
dc.relation.ispartofRespiratory Research, 2026, vol. 27, núm. 1
dc.rightscc-by-nc-nd (c)The Authors, 2026
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International*
dc.rights.accessRightsinfo:eu-repo/semantics/openAccess
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/*
dc.subjectConfocal laser endomicroscopy
dc.subjectImage-guided pleural biopsy
dc.subjectPleural disease
dc.subjectUltrasound
dc.titleDiagnostic yield and safety of needle-based COnfocaL LAser endomicroscopy and ultrasound-guided pleural BiOpsy in diagnosing patients with unknown pleuRAl effusion: a protocol for a mulTIcenter, randomized cONtrolled trial (COLLABORATION-II)
dc.typeinfo:eu-repo/semantics/article
dc.type.versioninfo:eu-repo/semantics/publishedVersion
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