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

  Proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific diagnosis is established based on the consensus definition.

  7 days after the procedure.

Secondary Outcomes (4)

• Complications incidence

  7 days after the procedure.

• Size of specimen

  Day 7 after procedure

• Quality of specimen

  7 days after procedure

• Interpretability of the specimen

  7 days after procedure

Other Outcomes (3)

• Procedural time

  1 day after procedure

• Pain degree

  1 day after procedure

• Participant satisfaction

  1 day after procedure.

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: September 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-02