Dual-function Semirigid Thoracoscopy Versus Semirigid Thoracoscopy for the Diagnosis of Pleural Diseases: A Multicenter Open-label Randomized Controlled Trial

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

About this trial

We designed and developed a novel dual-function semirigid thoracoscope (UE FET-680; UE Corporation, Zhejiang, China) with a straight channel adapted to flexible and rigid forceps for pleural biopsy. Our preclinical trial has proven that the dual-function semirigid thoracoscope has larger and deeper sampling while retaining the entire thoracic accessibility and flexible bronchoscopic maneuvering habits of the semirigid thoracoscope. We designed this study to directly compare the diagnostic yield, quality of sampling, and safety between the dual-function semirigid thoracoscope and semirigid thoracoscope.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Unilateral pleural effusion of unclear etiology after a less invasive diagnosis

Fully informed of the purpose and method of the study, agreed to participate in the study, and signed an informed consent form.

Disqualifiers

PaO2/FiO2 < 300

Tendency for uncontrolled bleeding, unstable cardiovascular status, or severe heart failure

A complete pleural symphysis, where it is not possible to create a pneumothorax

Refractory cough

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pleural biopsy using dual-function semirigid thoracoscopy

    Device

    Patients will receive pleural biopsy using dual-function semirigid thoracoscopy.

  • Pleural biopsy using semirigid thoracoscopy

    Device

    Patients received pleural biopsy using semirigid thoracoscopy

Treatment groups

334 Participants
are divided into 2 treatment groups
Group A: Dual-function semirigid thoracoscopyExperimental treatment 1 intervention
Group B: Semirigid thoracoscopyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic yield

The diagnostic yield in this study was defined as the proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific diagnosis is established.

Time frame
6 Month

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: