Pleural Diseases, Pleural Effusion
Conditions
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.
Interventions
PROCEDUREConfocal laser endomicroscopy guided pleural 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.
PROCEDUREPlerual biopsy using medical thoracoscopy
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.
Sponsors
China-Japan Friendship Hospital
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
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | Up to 12 months after the procedure | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Negative likelihood ratio | Up to 12 months after the procedure | 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. |
| Diagnostic sensitivity for specific diseases | Up to 12 months after the procedure | Sensitivity of the procedure for diagnosing malignant pleural mesothelioma, metastatic cancer, and tuberculous pleurisy, as determined by the reference standard. |
| Procedural time | Day of procedure | Total duration of the thoracoscopic procedure from insertion to removal of the thoracoscope. |
| Rate of adequate specimens for achieving molecular diagnosis | Within 2 weeks after the procedure (upon pathological reporting) | 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. |
| Incidence of procedure-related complications | From start of procedure up to 30 days post-procedure (or until chest tube removal and hospital discharge, whichever is longer) | 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. |
| Sampling quality (tissue depth and interpretability) | Within 2 weeks after the procedure (upon pathological assessment) | 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. |
Countries
China
Contacts
CONTACTGang Hou
Outcome results
None listed