Clinical trial NCT06744725: Dual-function Semirigid Thoracoscopy Versus Semirigid Thoracoscopy for the Diagnosis of Pleural Diseases: A Multicenter Open-label Randomized Controlled Trial
Official title: Dual-function Semirigid Thoracoscopy Versus Semirigid Thoracoscopy for the Diagnosis of Pleural Diseases: A Protocol for a Multicenter Open-label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pleural Diseases
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic yield
timeFrame: 6 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
References:
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