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

NCT07114783 | Not Yet Recruiting DMC

• 1 other identifier: 2025-UE-2
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

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

Keywords

Medical Thoracoscopy; Pleural Disease

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield

  Diagnostic yield is defined as the percentage of participants for whom the allocated thoracoscopic pleural biopsy provides a specific histopathological diagnosis. Malignant pleural disease and other defined histopathological diagnoses will be classified as diagnostic results. Non-specific pleuritis, fibrinous pleuritis, non-interpretable specimens, and cases in which no biopsy is obtained will be classified as non-diagnostic results.

  7 days after the procedure.

Secondary Outcomes (7)

• Procedural Sedative and Analgesic Requirements

  The day of thoracoscopy.

• Disease-specific Diagnostic Sensitivity

  Up to 12 months after thoracoscopy.

• Sampling Quality of Pleural Biopsy Specimens

  Up to 4 weeks after thoracoscopy.

• Procedure Duration

  The day of thoracoscopy.

• Operator-assessed Device Performance

  Immediately after the thoracoscopic procedure

Other Outcomes (2)

• Postprocedural Length of Hospital Stay

  At discharge from the index hospitalization, up to 30 days after thoracoscopy.

• Direct Medical Costs During the Index Hospitalization

  At discharge from the index hospitalization, up to 30 days after thoracoscopy.

Study Arms (2)

Dual-function Semi-rigid Thoracoscopy

EXPERIMENTAL

Device: Dual-function semi-rigid thoracoscopy

Rigid Thoracoscopy

OTHER

Device: Rigid thoracoscopy

Interventions

Dual-function semi-rigid thoracoscopy DEVICE

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

Dual-function Semi-rigid Thoracoscopy

Rigid thoracoscopy DEVICE

Patients received pleural biopsy via rigid thoracoscopy.

Rigid Thoracoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

MeSH Terms

Conditions

Pleural Effusion; Pleural Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Central Study Contacts

Mingming Deng, MD.,PhD.

CONTACT

+86 18801336854; isdeng1017@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication of the main trial results and ending 5 years after publication.
• Access Criteria: Researchers who submit a methodologically sound proposal. Access will be subject to approval by the study investigators and execution of a formal data-sharing agreement.