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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Pleural biopsy using dual-function semirigid thoracoscopy
DevicePatients will receive pleural biopsy using dual-function semirigid thoracoscopy.
Pleural biopsy using semirigid thoracoscopy
DevicePatients received pleural biopsy using semirigid thoracoscopy
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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