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

Not Applicable

Not yet recruiting

• Conditions: Pleural Diseases; Pleural Effusion

• Registration Number: NCT06741839
• Lead Sponsor: China-Japan Friendship Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-16
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-19
• Study Start: 2025-01-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Patients with unilateral pleural effusion of unclear aetiology after less invasive means of diagnosis;
• Patients who intend to undergo a thoracoscopic pleural biopsy to determine the cause of pleural effusion;
• Sign informed consent.

Exclusion Criteria

• There is an uncorrectable coagulation disorder or anticoagulation therapy that cannot be stopped before surgery;
• Hemodynamic instability;
• Refractory hypoxemia;
• Patients with pregnant and lactating patients
• Any illness or condition that interferes with the completion of the initial or subsequent assessment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The number of biopsies obtained for pathological diagnosis	12 months

Secondary Outcome Measures

Name	Time	Method
Incidence of operation-related complications	7 days
Diagnostic accuracy of pleural diseases	12 months
time of operation	the day of operation
Overall diagnosis rate of pleural disease	12 months