The Diagnostic Value of Bronchoscopic Needle-based Confocal Laser Endomicroscopy (nCLE) As a Real-time Detection Tool for Diagnosing Peripheral Lung Cancer: a Multi-centre Randomised Controlled Trial
NCT ID: NCT06739421
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1040 participants
INTERVENTIONAL
2025-01-01
2026-01-31
Brief Summary
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Participants will divided into nCLE-NB-rEBUS-forcep biopsy group, nCLE-NB-rEBUS-TBCB group, NB-rEBUS-forcep biopsy group, and NB-rEBUS-TBCB group at a 1:1:1:1 ratio by using central, computerized random sequence, and then undertake nCLE-NB-rEBUS-forcep biopsy, nCLE-NB-rEBUS-TBCB, NB-rEBUS-forcep biopsy, and NB-rEBUS-TBCB according to the group.
Researchers will compare the diagnostic yield and incidence of adverse events of the four biopsy techniques.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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nCLE-NB-rEBUS-forcep biopsy
The participants would undergo lung biopsy using forcep, under the guidance of bronchoscopic needle-based confocal laser endomicroscopy (nCLE) with the assistance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
nCLE-NB-rEBUS-forcep biopsy
The participants would undergo lung biopsy using forcep, under the guidance of bronchoscopic needle-based confocal laser endomicroscopy (nCLE) with the assistance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
nCLE-NB-rEBUS-TBCB
The participants would undergo transbronchial crybiopsy (TBCB) , under the guidance of bronchoscopic needle-based confocal laser endomicroscopy (nCLE) with the assistance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
nCLE-NB-rEBUS-TBCB
The participants would undergo transbronchial crybiopsy (TBCB), under the guidance of bronchoscopic needle-based confocal laser endomicroscopy (nCLE) with the assistance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
NB-rEBUS-forcep biopsy
The participants would undergo lung biopsy using forcep, under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
NB-rEBUS-forcep biopsy
The participants would undergo lung biopsy using forcep, under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
NB-rEBUS-TBCB
The participants would undergo transbronchial crybiopsy (TBCB) , under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
NB-rEBUS-TBCB
The participants would undergo transbronchial crybiopsy (TBCB), under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
Interventions
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nCLE-NB-rEBUS-forcep biopsy
The participants would undergo lung biopsy using forcep, under the guidance of bronchoscopic needle-based confocal laser endomicroscopy (nCLE) with the assistance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
nCLE-NB-rEBUS-TBCB
The participants would undergo transbronchial crybiopsy (TBCB), under the guidance of bronchoscopic needle-based confocal laser endomicroscopy (nCLE) with the assistance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
NB-rEBUS-forcep biopsy
The participants would undergo lung biopsy using forcep, under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
NB-rEBUS-TBCB
The participants would undergo transbronchial crybiopsy (TBCB), under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
Eligibility Criteria
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Inclusion Criteria
* patients requiring diagnostic bronchoscopy procedure to determine the benign or malignant nature of the lung nodule;
* Patients who can understand the purpose of the trial, participate voluntarily and sign an informed consent form.
Exclusion Criteria
* Endobronchial visible malignancy on bronchoscopic inspection;
* Target lesion within reach of the linear EBUS scope;
* Failure to comply with the study protocol;
* Known allergy or risk factors for an allergic reaction to fluorescein;
* Pregnancy or breast feeding;
* Haemodynamic instability;
* Refractory hypoxaemia;
* Therapeutic anticoagulant use that cannot be withheld for an appropriate interval before the procedure;
* Unable to tolerate general anaesthesia according to the anaesthesiologist;
* Undergoing chemotherapy as several chemotherapies have fluorescent properties at the same wavelength (eg, doxorubicin).
18 Years
90 Years
ALL
No
Sponsors
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China-Japan Friendship Hospital
OTHER
Responsible Party
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Gang Hou
Professor
Locations
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China-Japan Friendship Hospital, , 100029
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Deng Mingming, MD
Role: primary
Other Identifiers
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2022YFC2404404-PN
Identifier Type: -
Identifier Source: org_study_id