NCT06741839 Confocal Laser Endomicroscopy Guided Medical Thoracoscopy for the Diagnosis of Pleural Disease

Trial Parameters

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Brief Summary

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.

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.

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