NCT07114783

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

Dual-function Semirigid Thoracoscopy Versus Rigid Thoracoscopy for the Diagnosis of Pleural Disease: a Randomised Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: China-Japan Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Dual-function semi-rigid thoracoscopy	Patients received pleural biopsy via dual-function semi-rigid thoracoscopy.
DEVICE	Rigid thoracoscopy	Patients received pleural biopsy via rigid thoracoscopy.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-08-11
• Last updated: 2025-08-11