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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina-Japan Friendship Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Dual-function semi-rigid thoracoscopy
  • Rigid thoracoscopy

Treatment groups

92 Participants
are divided into 2 treatment groups

Locations

This trial has no locations