Dual-function Semirigid Thoracoscopy Versus Rigid Thoracoscopy for the Diagnosis of Pleural Disease
- Conditions
- Pleural Effusion Disorder
- Registration Number
- NCT07114783
- Lead Sponsor
- China-Japan Friendship Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 92
- 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;
- Patients with Eastern Cooperative Oncology Group performance status 4;
- Patients did not agree to participate in this study;
- Participation in other studies within three months without withdrawal or termination will affect the observation of this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Diagnostic yield 7 days after the procedure. Proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific diagnosis is established based on the consensus definition.
- Secondary Outcome Measures
Name Time Method Complications incidence 7 days after the procedure. The incidence of procedure-related complications.
Size of specimen Day 7 after procedure Regarding biopsy size the total area is measured by the largest cross-sectional area under magnificence. Each sample was measured twice and the arithmetic mean of both measurements is accepted. All areas were calculated automatically and provided in mm2 by using ImageJ software (ImageJ, Marlyand, USA).
Quality of specimen 7 days after procedure Biopsy quality was determined by tissue depth. A thoracoscopic biopsy specimen, including fatty tissue of the thoracic wall, was considered to be a deep biopsy and therefore of high quality.
Interpretability of the specimen 7 days after procedure The interpretability of specimens is assessed as below:
1. Easily interpretable: enough tissue with all elements required for diagnosis;
2. Interpretability with some difficulty: less tissue or fewer diagnostic elements, diagnosis less reliable;
3. Interpretable with great difficulty: little tissue or scant diagnostic elements, low reliability of diagnosis;
4. Non-interpretable: diagnosis not possible.