Menu
Not yet recruiting NCT07114783

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

No phase Interventional Pleural Effusion Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dual-function semi-rigid thoracoscopy, Rigid thoracoscopy.
Who it may be relevant to
Registry conditions: Pleural Effusion Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Diagnostic yield [Time frame: 7 days after the procedure.]
Secondary outcome measures (7)
  • Procedural Sedative and Analgesic Requirements [Time frame: The day of thoracoscopy.]
  • Disease-specific Diagnostic Sensitivity [Time frame: Up to 12 months after thoracoscopy.]
  • Sampling Quality of Pleural Biopsy Specimens [Time frame: Up to 4 weeks after thoracoscopy.]
  • Procedure Duration [Time frame: The day of thoracoscopy.]
  • Operator-assessed Device Performance [Time frame: Immediately after the thoracoscopic procedure]
  • Post-thoracoscopy Pain Score [Time frame: At 2, 6, 12, 24, and 48 hours after thoracoscopy]
  • Procedure-related Complications [Time frame: At discharge from the index hospitalization, up to 30 days after thoracoscopy.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Xu L, Liu X, Wu H, Xie Z, Wang K, Deng M, Zheng Z, Hou G. Diagnostic yield and safety of Dual-functIon Semi-rigid thoraCoscOpy Versus rigid thoracoscopy for the diagnosis of plEuRal disease (DISCOVER-2): protocol for a randomised controlled trial. BMJ Open. 2026 Jul 8;16(7):e118022. doi: 10.1136/bmjopen-2026-118022. PMID 42419899

Identifiers

NCT: NCT07114783 · 2025-UE-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗