Confocal Laser Endomicroscopy Assisted Ultrasound Guided Pleural Biopsy

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.

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Key information

Conditions

Pleural Effusion Disorder Pleural Diseases Pleural Effusion Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Confocoal laser endomicroscopy-assisted ultrasound-guided pleural biopsy

Procedure

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.

Other names: CLE-assisted ultrasound-guided pleural biopsy

Ultrasound-guided pleural biopsy

Procedure

Using ultrasound to detect the biopsy site and perform pleural biopsy.

Primary outcomes

Diagnostic yield

Time frame: The day 7 after patients received CLE-assisted ultrasound-guided pleural biopsy.

The proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific diagnosis is established based on the consensus definition.

Study contacts

Contact information is provided by the study sponsor or research team.

Mingming Deng, Doctor

CONTACT

[email protected]

+86 18801336854

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study 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）

Acronym: Confocal laser

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Jun 27, 2025
Registry last updated: Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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