Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06741839 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhaseNot applicable
Started2025-03-11
View on ClinicalTrials.gov ↗

Amendment history

2026-04-11
Not Yet Recruiting→Recruiting Study Status, Sponsor/Collaborators, Oversight, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-12-31→2027-05
Completion date2026-12-31→2027-05
Start dateestimated 2025-01-01→confirmed 2025-03-11
Enrollment target130→158
Study sites0→1
Eligibility criteria+21 characters
Inclusion Criteria: PatientsAge with≥ unilateral18 years; Evidence of exudative pleural effusion ofin unclearwhich aetiologya afterspecific lessdiagnosis could not be determined using clinical, radiological, laboratory, or cytological examinations Willingness to participate in the study and undergo an invasive means of diagnosisprocedure.; Patients who intend to undergo a thoracoscopic pleural biopsy to determine the cause of pleural effusion; Sign informed consent. Exclusion Criteria: TherePleural is an uncorrectable coagulation disorderthickening or anticoagulationpleural-based therapymass t [...] [...]
Secondary endpoints4 to 6 entries
Negative likelihood ratio Diagnostic sensitivity for specific diseases Procedural time Rate of adequate specimens for achieving molecular diagnosis Incidence of operationprocedure-related complications DiagnosticSampling accuracyquality of(tissue pleuraldepth diseases timeand of operation Overall diagnosis rate of pleural diseaseinterpretability)
Primary endpoints1 entry, revised
TheDiagnostic number of biopsies obtained for pathological diagnosisyield
Collaborators+252 characters
Shanghai Rui Jin Hospital Henan Provincial People's Hospital The Second Affiliated Hospital of Harbin Medical University Anhui Chest Hospital Wuhan Pulmonary Hospital Shandong Public Health Clinical Center The Second People's Hospital of Gansu Province
2024-12-16
Original filing
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.
Trial Details
NCT Number NCT06741839
Lead Sponsor China-Japan Friendship Hospital
Collaborators: Shanghai Rui Jin Hospital, Henan Provincial People's Hospital, The Second Affiliated Hospital of Harbin Medical University, Anhui Chest Hospital, Wuhan Pulmonary Hospital, Shandong Public Health Clinical Center, The Second People's Hospital of Gansu Province
Conditions Pleural Diseases, Pleural Effusion
Enrollment 158 participants
Start Date 2025-03-11
Primary Completion 2027-05 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-04-15