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

NCT ID: NCT07114783

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-08-31

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.

Conditions

Pleural Effusion Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Dual-function Semi-rigid Thoracoscopy

Group Type: EXPERIMENTAL

Dual-function semi-rigid thoracoscopy

Intervention Type: DEVICE

Patients received pleural biopsy via dual-function semi-rigid thoracoscopy.

Rigid Thoracoscopy

Group Type: OTHER

Rigid thoracoscopy

Intervention Type: DEVICE

Patients received pleural biopsy via rigid thoracoscopy.

Interventions

Dual-function semi-rigid thoracoscopy

Patients received pleural biopsy via dual-function semi-rigid thoracoscopy.

Intervention Type: DEVICE

Rigid thoracoscopy

Patients received pleural biopsy via rigid thoracoscopy.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gang Hou

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mingming Deng, MD.,PhD.

Role: CONTACT

isdeng1017@163.com

+86 18801336854

Other Identifiers

2025-UE-2

Identifier Type: -

Identifier Source: org_study_id