Using confocal laser endomicroscopy during medical thoracoscopy to diagnose pleural disease

Efficacy and Safety of Confocal Laser Endomicroscopy Guided Medical Thoracoscopy for the Diagnosis of Pleural Disease: a Multicenter Randomized Controlled Trial

This trial tests whether using confocal laser endomicroscopy during thoracoscopy helps doctors find the cause of unexplained fibrinous pleurisy in adults.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 158 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: China-Japan Friendship Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06741839 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with exudative pleural effusion of unknown etiology who are willing to undergo semirigid thoracoscopic pleural biopsy and provide informed consent.

Not a fit: Patients without pleural effusion, those with parapneumonic effusion, hemodynamic instability, or other contraindications to thoracoscopy are unlikely to benefit from this procedure.

Why it matters

Potential benefit: If successful, this approach could speed and improve diagnostic accuracy for unexplained pleural effusions while potentially reducing the number of tissue samples and procedure-related morbidity.

How similar studies have performed: Small pilot and observational studies of confocal laser endomicroscopy in pleural and other organ systems have shown promise, but randomized data for pleural use remain limited.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Gang Hou

Conditions: Pleural Diseases, Pleural Effusion