Using confocal laser endomicroscopy during medical thoracoscopy to diagnose pleural disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter randomized controlled trial enrolling adults with exudative pleural effusion of unknown cause who are scheduled for thoracoscopic pleural biopsy. Participants are randomized 1:1 to either nCLE-guided biopsy or standard visual-guided biopsy during semirigid medical thoracoscopy. The study compares concordance of nCLE-guided or random biopsies with final histopathology, whether nCLE guidance reduces the number of biopsies needed, and records short-term postoperative complications to evaluate safety. Procedures are performed at participating tertiary hospitals in China under informed consent.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years;
* Evidence of exudative pleural effusion in which a specific diagnosis could not be determined using clinical, radiological, laboratory, or cytological examinations
* Willingness to participate in the study and undergo an invasive procedure.;

Exclusion Criteria:

* Pleural thickening or pleural-based mass without pleural effusion on radiologic examination;
* Hemodynamic instability;
* Presence of parapneumonic effusion;
* Any contraindication to pleural biopsy or semirigid thoracoscopy;
* Participation in other studies within three months without withdrawal or termination.

Where it's running

• China-Japan Friendship Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Gang Hou
• Email: hougangcmu@163.com
• Phone: 13840065481

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.