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

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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06744725

Enrollment

334

Registered

2024-12-20

Start date

2025-01-01

Completion date

2026-01-01

Last updated

2024-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pleural Diseases

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.

Interventions

DEVICEPleural biopsy using dual-function semirigid thoracoscopy

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

DEVICEPleural biopsy using semirigid thoracoscopy

Patients received pleural biopsy using semirigid thoracoscopy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic yield	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.

Countries

China

Contacts

Primary ContactGang Hou, MD,PhD

hougangcmu@163.com010-84205729

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026