Medical thoracoscopy (rigid and semirigid) is an effective, safe method for diagnosing and managing pleural diseases. Rigid thoracoscopy demonstrates superior overall diagnostic yield compared to semirigid techniques (flexible forceps/cryobiopsy) due to its ability to obtain larger, deeper biopsies with rigid forceps. However, diagnostic rates become similar when biopsies are successfully obtained.
Limitations of rigid thoracoscopy include restricted maneuverability (especially in posterior/mediastinal areas), increased procedural pain from leveraging against ribs and larger trocars, higher sedation requirements, and a steep learning curve for pulmonologists.
To address these issues, a novel dual-function semirigid thoracoscope (UE FET-680, China) was developed. Its straight working channel accommodates standard rigid biopsy forceps, potentially matching rigid thoracoscopy's diagnostic yield while improving usability. This randomized trial will compare the efficacy and safety of this new device versus conventional rigid thoracoscopy in undiagnosed exudative pleural effusions.
Age ≥ 18 years;
Patients with unilateral pleural effusion of unclear aetiology after less invasive means of diagnosis;
Fully informed of the purpose and method of the study, agreed to participate in the study, and signed the informed consent form.
Patients with PaO2/FiO2 <300;
Patients with a tendency for uncontrolled bleeding, unstable cardiovascular status or severe heart failure;
Patients with complete pleural symphysis, where it was not possible to create a pneumothorax, were excluded subsequently;
Patients with refractory cough;
Parallel
Dual-function semi-rigid thoracoscopy
DevicePatients received pleural biopsy via dual-function semi-rigid thoracoscopy.
Rigid thoracoscopy
DevicePatients received pleural biopsy via rigid thoracoscopy.
Diagnostic yield
Diagnostic yield is defined as the percentage of participants for whom the allocated thoracoscopic pleural biopsy provides a specific histopathological diagnosis. Malignant pleural disease and other defined histopathological diagnoses will be classified as diagnostic results. Non-specific pleuritis, fibrinous pleuritis, non-interpretable specimens, and cases in which no biopsy is obtained will be classified as non-diagnostic results.
Procedural Sedative and Analgesic Requirements
Procedural sedative and analgesic requirements will be assessed by recording the total dose of each sedative or analgesic agent administered during thoracoscopy, including midazolam, pentazocine, and tramadol. The dose of each agent will be recorded separately in milligrams and summarised by treatment group
Disease-specific Diagnostic Sensitivity
Disease-specific diagnostic sensitivity is defined as the percentage of participants with a specific final diagnosis according to the reference standard whose allocated thoracoscopic pleural biopsy provides a specific histopathological diagnosis supporting the same disease. Participants with non-specific biopsy findings who are subsequently diagnosed with malignant pleural disease or tuberculous pleuritis during follow-up will be classified as false-negative biopsy results for the corresponding disease.
Sampling Quality of Pleural Biopsy Specimens
Sampling quality will be assessed using specimen size, specimen depth, and specimen interpretability. Specimen size will be measured as the largest cross-sectional area of the processed biopsy specimens on microscopic glass slides using ImageJ software and reported in square millimetres. Specimen depth will be assessed according to the presence of thoracic wall fatty tissue. Specimen interpretability will be classified as easily interpretable, interpretable with some difficulty, interpretable with great difficulty, or non-interpretable.
Procedure Duration
Procedure duration will be measured in minutes from skin incision to completion of chest tube placement and wound closure.
Postprocedural Length of Hospital Stay
Postprocedural length of hospital stay is defined as the number of days from the date of thoracoscopy to hospital discharge.
Direct Medical Costs During the Index Hospitalization
Direct medical costs during the index hospitalization will be extracted from hospital billing records. These costs include procedure-related costs, anaesthetic and analgesic medication costs, chest tube and drainage-related costs, postprocedural imaging and management costs, and postprocedural hospitalization costs. Costs will be reported in Chinese Yuan.
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