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

China-Japan Friendship Hospital

Status: Not yet enrolling

Conditions: Pleural Diseases

Treatments: Device: Pleural biopsy using semirigid thoracoscopy; Device: Pleural biopsy using dual-function semirigid thoracoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06744725

2024-UE-1

Details and patient eligibility

About

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.

Enrollment: 334 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

334 participants in 2 patient groups

Dual-function semirigid thoracoscopy

Experimental group

Description:

Patients received pleural biopsy using dual-function semirigid thoracoscopy.

Treatment:

Device: Pleural biopsy using dual-function semirigid thoracoscopy

Semirigid thoracoscopy

Experimental group

Description:

Patients received pleural biopsy using semirigid thoracoscopy

Treatment:

Device: Pleural biopsy using semirigid thoracoscopy