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NCT Number: NCT06744725

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

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Key information

Conditions

Pleural Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pleural biopsy using dual-function semirigid thoracoscopy

Device

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

Pleural biopsy using semirigid thoracoscopy

Device

Patients received pleural biopsy using semirigid thoracoscopy

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gang Hou, MD,PhD

CONTACT

[email protected]

010-84205729

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 20, 2024
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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