Pleural Effusion Disorder
Conditions
Keywords
Medical Thoracoscopy, Pleural Disease
Brief summary
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.
Interventions
DEVICEDual-function semi-rigid thoracoscopy
Patients received pleural biopsy via dual-function semi-rigid thoracoscopy.
DEVICERigid thoracoscopy
Patients received pleural biopsy via rigid thoracoscopy.
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years; 2. Patients with unilateral pleural effusion of unclear aetiology after less invasive means of diagnosis; 3. Fully informed of the purpose and method of the study, agreed to participate in the study, and signed the informed consent form.
Exclusion criteria
1. Patients with PaO2/FiO2 \<300; 2. Patients with a tendency for uncontrolled bleeding, unstable cardiovascular status or severe heart failure; 3. Patients with complete pleural symphysis, where it was not possible to create a pneumothorax, were excluded subsequently; 4. Patients with refractory cough; 5. Patients with Eastern Cooperative Oncology Group performance status 4; 6. Patients did not agree to participate in this study; 7. Participation in other studies within three months without withdrawal or termination will affect the observation of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | 7 days after the procedure. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Sedative and Analgesic Requirements | The day of thoracoscopy. | 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 | Up to 12 months after thoracoscopy. | 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 | Up to 4 weeks after thoracoscopy. | 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 | The day of thoracoscopy. | Procedure duration will be measured in minutes from skin incision to completion of chest tube placement and wound closure. |
| Operator-assessed Device Performance | Immediately after the thoracoscopic procedure | Operator-assessed device performance will include image quality, ease of manoeuvring, ease of obtaining a biopsy sample, and the operator's expectation that the biopsy sample will provide a definitive histological diagnosis. Each domain will be assessed immediately after the procedure using a visual analogue scale ranging from 0 to 100, with higher scores indicating better operator-assessed performance. |
| Post-thoracoscopy Pain Score | At 2, 6, 12, 24, and 48 hours after thoracoscopy | Patient-reported post-thoracoscopy pain will be assessed using a 100-mm visual analogue scale while at rest and while coughing. Scores range from 0 to 100, with higher scores indicating more severe pain. |
| Procedure-related Complications | At discharge from the index hospitalization, up to 30 days after thoracoscopy. | Procedure-related complications will be classified as major or minor complications. Major complications include empyema, major haemorrhage defined as a drop in haemoglobin of at least 1 g/dL or requiring blood transfusion, persistent air leak for more than 3 days, and re-expansion pulmonary oedema. Minor complications include subcutaneous emphysema, operative site infection, non-infective fever, and minor haemorrhage. |
Contacts
CONTACTMingming Deng, MD.,PhD.
Outcome results
None listed