Clinical Trial

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

Not Yet Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-04.
Trial Details
NCT Number NCT07114783
Lead Sponsor China-Japan Friendship Hospital
Conditions Pleural Effusion Disorder
Enrollment 92 participants
Start Date 2026-08
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-22