Study of Confocal Laser Endomicroscopy Guided Thoracoscopy to Diagnose Pleural Diseases and Pleural Effusion

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.

Confocal Laser Endomicroscopy Guided Medical Thoracoscopy for the Diagnosis of Pleural Disease