Dual-function Semirigid Thoracoscopy Versus Rigid Thoracoscopy for the Diagnosis of Pleural Disease

China-Japan Friendship Hospital

Status: Not yet enrolling

Conditions: Pleural Effusion Disorder

Treatments: Device: Rigid thoracoscopy; Device: Dual-function semi-rigid thoracoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT07114783

2025-UE-2

Details and patient eligibility

About

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.

Enrollment: 92 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 2 patient groups

Dual-function Semi-rigid Thoracoscopy

Experimental group

Treatment:

Device: Dual-function semi-rigid thoracoscopy

Rigid Thoracoscopy

Other group

Treatment:

Device: Rigid thoracoscopy