Actively Recruiting
Efficacy and Safety of Confocal Laser Endomicroscopy Guided Medical Thoracoscopy for the Diagnosis of Pleural Disease: A Multicenter Randomized Controlled Trial
Led by China-Japan Friendship Hospital · Updated on 2026-04-15
158
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
China-Japan Friendship Hospital
Lead Sponsor
S
Shanghai Rui Jin Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of confocal laser endomicroscopy (nCLE) guided thoracoscopic biopsy to improve the diagnosis of fibrinous pleurisy of unknown cause. This multicenter randomized controlled trial compares the safety and effectiveness of nCLE guided biopsy with conventional thoracoscopic biopsy in patients who need pleural biopsy for unclear exudative pleural effusion. The goal is to see if nCLE can better identify benign and malignant pleural lesions, reduce the number of biopsies needed, and maintain safety. Participants are randomly assigned to one of two groups: the experimental group receives nCLE guided pleural biopsy via semi-rigid thoracoscopy, where the parietal pleura is examined systematically to locate biopsy sites, followed by multiple tissue samples. The comparison group undergoes conventional pleural biopsy using semi-rigid thoracoscopy, with biopsies taken from suspected areas under direct vision. Both groups receive eight biopsies, which are analyzed for diagnosis. During the study, participants undergo thoracoscopic procedures guided by either nCLE or visual inspection, with tissue samples collected for histopathology. Researchers will monitor diagnostic accuracy, procedural time, specimen quality, and complications for up to 12 months after biopsy. Safety is evaluated through follow-up of procedure-related complications up to 30 days post-procedure. The study aims to provide comprehensive data on the diagnostic yield and safety of nCLE guided thoracoscopic biopsy.
CONDITIONS
Brief Title
Confocal Laser Endomicroscopy Guided Medical Thoracoscopy for the Diagnosis of Pleural Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Evidence of exudative pleural effusion with no specific diagnosis from clinical, radiological, laboratory, or cytological exams
- Willingness to participate in the study and undergo an invasive procedure
You will not qualify if you...
- Pleural thickening or pleural-based mass without pleural effusion on imaging
- Hemodynamic instability
- Presence of parapneumonic effusion
- Any contraindication to pleural biopsy or semirigid thoracoscopy
- Participation in other studies within the past three months without withdrawal or termination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of procedure
Participants undergo medical thoracoscopy with either confocal laser endomicroscopy guided pleural biopsy or conventional pleural biopsy to diagnose pleural disease.
1 procedure visit (in-person)
Duration - Up to 12 months after the procedure
Participants are monitored for procedure-related complications and to assess diagnostic outcomes including specimen adequacy and diagnostic yield.
Visits as needed up to 12 months post-procedure
Trial Site Locations
Total: 1 location
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
Research Team
G
Gang Hou
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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