An interventional study of Confocal laser endomicroscopy guided pleural biopsy using medical thoracoscopy and Plerual biopsy using medical thoracoscopy in Pleural Diseases and Pleural Effusion, sponsored by China-Japan Friendship Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by China-Japan Friendship Hospital · Not applicable, Interventional, and Diagnostic
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.
241 studies on the registry are indexed under Pleural Effusion; 50 are open to participants now.
This study's planned enrollment of 158 is above the median of 80 across 142 interventional studies indexed under Pleural Effusion.
Browse Pleural Effusion studies →China-Japan Friendship Hospital is the lead sponsor of 178 studies on the registry; 111 are open to participants now.
Compared within Pleural Effusion, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pleural Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
pCLE will be introduced to detect suspected areas of the parietal pleura. The pCLE inspection will follow a standardized protocol with two main steps. First, any visible abnormalities under white light, such as nodules or thickening, will be examined with pCLE to evaluate intralesional heterogeneity and determine the best biopsy site. Second, the basal pleura will be systematically swept, covering at least two intercostal spaces above the costophrenic recess, including the diaphragmatic pleura and lower posterior chest wall, which are common sites for malignant involvement. After confirming the targeted area of the parietal pleura for pleural biopsy, the pCLE probe will be withdrawn, and a flexible forceps biopsy will be performed. This process will be repeated eight times, and eight samples will be obtained. All specimens will be transported in separate formalin containers with biopsy sequences for histopathological analysis.
Procedure: Confocal laser endomicroscopy guided pleural biopsy using medical thoracoscopy
For patients assigned to receive pleural biopsy via semi-rigid thoracoscopy alone, the parietal, visceral, and diaphragmatic pleura will be inspected, and eight biopsies will be obtained under direct vision in all suspected areas of the parietal pleura.
Procedure: Plerual biopsy using medical thoracoscopy
After 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.
After 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.
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 procedure
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 procedure
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 procedure
Procedural time
Total duration of the thoracoscopic procedure from insertion to removal of the thoracoscope.
Time frame: Day of procedure
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)
Incidence of procedure-related complications
Occurrence of any adverse events related to the procedure, including but not limited to: prolonged air leak, hemorrhage (graded as nil/slight self-limiting, mild requiring local vasoactive medication, moderate-to-severe requiring electrocautery or argon plasma coagulation), subcutaneous emphysema, postoperative fever, empyema, wound infection, cardiac arrhythmias, hypotension, and chest wall seeding from mesothelioma.
Time frame: From start of procedure up to 30 days post-procedure (or until chest tube removal and hospital discharge, whichever is longer)
Sampling quality (tissue depth and interpretability)
Tissue depth: Biopsy quality determined based on tissue depth (e.g., deep biopsy including fatty tissue from the thoracic wall is considered high quality). Interpretability: Assessed as (a) easily interpretable (sufficient tissue with all diagnostic elements), (b) interpretable with some difficulty, (c) interpretable with great difficulty, (d) non-interpretable.
Time frame: Within 2 weeks after the procedure (upon pathological assessment)
Plan to share: No
Started Mar 2025 (actual). Primary completion is estimated for May 2027, 26 months after the start.
Of 61 non-industry interventional studies with no phase under Pleural Effusion, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 52. This study's planned 26 months is below that.
Counting every sponsor, half of 63 studies reached it within 26 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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