Dual-function Semirigid Thoracoscopy Versus Semirigid Thoracoscopy for the Diagnosis of Pleural Diseases: A Protocol for a Multicenter Open-label Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 334
- Locations
- 1
- Primary Endpoint
- Diagnostic yield
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
- •Eastern Cooperative Oncology Group performance status 4
- •Disagreements regarding study participation
- •Participation in other studies within three months without withdrawal or termination.
Arms & Interventions
Dual-function semirigid thoracoscopy
Patients received pleural biopsy using dual-function semirigid thoracoscopy.
Intervention: Pleural biopsy using dual-function semirigid thoracoscopy (Device)
Semirigid thoracoscopy
Patients received pleural biopsy using semirigid thoracoscopy
Intervention: Pleural biopsy using semirigid thoracoscopy (Device)
Outcomes
Primary Outcomes
Diagnostic yield
Time Frame: 6 Month
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Gang Hou
Professor
China-Japan Friendship Hospital