Confocal Laser Endomicroscopy Guided Medical Thoracoscopy for the Diagnosis of Pleural Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina-Japan Friendship Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Confocal laser endomicroscopy guided pleural biopsy using medical thoracoscopy
Procedure/SurgeryAfter the completion of the routine thoracoscopic examination, the biopsy location was determined based on the results of chest CT/ ultrasound. The benign and malignant states of pleural lesions were explored by nCLE and image records were collected. Then, the biopsy tissues were collected under the guidance of nCLE.
Plerual biopsy using medical thoracoscopy
Procedure/SurgeryAfter the completion of the routine thoracoscopic examination, the biopsy location was determined according to the results of chest CT/ ultrasound, and random pathological biopsy was performed, and biopsy tissues were collected by biopsy forceps.
Treatment groups
158 Participants
are divided into 2 treatment groupsGroup A: pCLE guided pleural biopsy via semi-rigid thoracoscopyExperimental treatment 1 intervention
Group B: Conventional Pleural biopsy via semi-rigid thoracoscopyPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic yield
The proportion of participants in whom a specific diagnosis is established following pleural biopsy via semirigid thoracoscopy, based on histopathological analysis and final reference diagnosis (including 12-month follow-up for initially benign or nonspecific results).
Time frame
Up to 12 months after the procedureSecondary outcomes
1
Negative likelihood ratio
The negative likelihood ratio is defined as the probability of a negative biopsy result (i.e., no specific malignant or tuberculous diagnosis) in a patient who truly has the target disease (malignant pleural mesothelioma, metastatic cancer, or tuberculous pleurisy), divided by the probability of a negative biopsy result in a patient who does not have the disease. Because pleural biopsy results have no false positives in this study (specificity = 1, false-positive rate = 0), the NLR simplifies to 1 - sensitivity. It will be calculated using the final reference diagnosis at 12 months as the gold standard.
Time frame
Up to 12 months after the procedure2
Diagnostic sensitivity for specific diseases
Sensitivity of the procedure for diagnosing malignant pleural mesothelioma, metastatic cancer, and tuberculous pleurisy, as determined by the reference standard.
Time frame
Up to 12 months after the procedure3
Procedural time
Total duration of the thoracoscopic procedure from insertion to removal of the thoracoscope.
Time frame
Day of procedure4
Rate of adequate specimens for achieving molecular diagnosis
Proportion of biopsy specimens that are sufficient for predictive molecular marker analysis according to tumor type (e.g., PD-L1, EGFR, ALK, ROS-1, HER2, ER, PR, BRCA, RAS, BRAF, etc.). Specimens are categorized as: (a) successful molecular marker analysis, (b) unsuccessful molecular marker analysis (explicit test failure), (c) not sent despite relevance.
Time frame
Within 2 weeks after the procedure (upon pathological reporting)Sponsors and contacts
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China-Japan Friendship Hospital
Lead sponsor
Shanghai Rui Jin Hospital
Collaborator
Henan Provincial People's Hospital
Collaborator
The Second Affiliated Hospital of Harbin Medical University
Collaborator
Anhui Chest Hospital
Collaborator
Wuhan Pulmonary Hospital
Collaborator
Shandong Public Health Clinical Center
Collaborator
The Second People's Hospital of Gansu Province
Collaborator
Source ClinicalTrials.gov