Confocal Laser Endomicroscopy Assisted Ultrasound Guided Pleural Biopsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Confocoal laser endomicroscopy-assisted ultrasound-guided pleural biopsy, Ultrasound-guided pleural biopsy.
- Who it may be relevant to
- Registry conditions: Pleural Effusion Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Diagnostic Yield and Safety of Probe-based COnfocaL LAser Endomicroscopy and Ultrasound-guided Pleural BiOpsy in Diagnosing Patients With Unknown pleuRAl Effusion: a Protocol of a Multicenter, Randomized cONtrolled Trial (COLLABORATION-Ⅱ）
Overview
This study aimed to evaluate the diagnostic yield and safety of confocal laser endomicroscopy and ultrasound-guided pleural biopsy in diagnosing patients with unknown pleural effusion.
Interventions
- Procedure Confocoal laser endomicroscopy-assisted ultrasound-guided pleural biopsy
Using the probe-based confocal laser endomicroscopy to detect the pleural, and ensure the biopsy location. Then, use the pleural biopsy tool to complete the pleural biopsy. The whole procession will under the ultrasound guidance. - Procedure Ultrasound-guided pleural biopsy
Using ultrasound to detect the biopsy site and perform pleural biopsy.
Primary outcome measures
- Diagnostic yield [Time frame: The day 7 after patients received CLE-assisted ultrasound-guided pleural biopsy.]
Eligibility criteria
Inclusion criteria
- Adult patients with exudative pleural effusion of unknown origin
- Patients with negative pleural fluid cytology results
- Patients diagnosed with a probable malignant pleural effusion but without a definite diagnosis and requiring further pathological evaluation
- Patients who are fully informed of the purpose and method of the study, agree to participate in the study, and sign an informed consent form
Exclusion criteria
- Inability or refusal to undergo UGBx
- Patients with any contraindications for pleural biopsy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Zheng Z, Ye S, Liu X, Xiao K, Deng M, Tong R, Porcel JM, Wang T, Hou G. 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). Respir Res. 2026 Apr 23;27(1):245. doi: 10.1186/s12931-026-03674-7. PMID 42026599
Identifiers
NCT: NCT07040241 · 2025-COLLABERATION-Ⅱ