Actively Recruiting
Confocal Laser Endomicroscopy Guided Medical Thoracoscopy for the Diagnosis of Pleural Disease
Led by China-Japan Friendship Hospital · Updated on 2026-04-15
158
Participants Needed
1
Research Sites
111 weeks
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
A prospective multicenter randomized controlled trial was conducted to evaluate the efficacy and safety of thoracoscopic biopsy guided by confocal optical real-time microscopic imaging (nCLE) in the diagnosis of fibrinal pleurisy of unknown etiology. Patients with fibrinous pleurisy of unknown etiology who were to undergo thoracoscopic pleural biopsy were enrolled and informed consent was signed. Subjects were randomized to either the nCLE guided biopsy Group (Group A) or the visual biopsy group (Group B) according to the randomization table (1:1 ratio). nCLE was used to probe the benign and malignant status of pleural lesions, compare the consistency of random pathological biopsy or nCLE guided biopsy with histopathological results, compare whether nCLE guided biopsy can reduce the number of thoracoscopic biopsies, and follow up short-term postoperative complications to evaluate its safety.
CONDITIONS
Official Title
Confocal Laser Endomicroscopy Guided Medical Thoracoscopy for the Diagnosis of Pleural Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 18 years
- Evidence of exudative pleural effusion with no specific diagnosis after clinical, radiological, laboratory, or cytological exams
- Willingness to participate and undergo an invasive procedure
You will not qualify if you...
- Pleural thickening or pleural-based mass without pleural effusion on radiologic exam
- Hemodynamic instability
- Presence of parapneumonic effusion
- Any contraindication to pleural biopsy or semirigid thoracoscopy
- Participation in other studies within 3 months without withdrawal or termination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
Research Team
G
Gang Hou
CONTACT
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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