NCT06741839 Confocal Laser Endomicroscopy Guided Medical Thoracoscopy for the Diagnosis of Pleural Disease
| NCT ID | NCT06741839 |
| Status | Recruiting |
| Phase | — |
| Sponsor | China-Japan Friendship Hospital |
| Condition | Pleural Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 158 participants |
| Start Date | 2025-03-11 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 158 participants in total. It began in 2025-03-11 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06741839 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pleural Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06741839 currently recruiting?
Yes, NCT06741839 is actively recruiting participants. Contact the research team at hougangcmu@163.com for enrollment information.
Where is the NCT06741839 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06741839 clinical trial?
NCT06741839 is sponsored by China-Japan Friendship Hospital. The trial plans to enroll 158 participants.