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

China-Japan Friendship Hospital

Status: Not yet enrolling

Conditions: Lung Cancer, Small Cell; Lung Cancer, Non-Small Cell

Treatments: Procedure: NB-rEBUS-forcep biopsy; Procedure: nCLE-NB-rEBUS-TBCB; Procedure: nCLE-NB-rEBUS-forcep biopsy; Procedure: NB-rEBUS-TBCB

Study type: Interventional

Funder types: Other

Identifiers

NCT06739421

2022YFC2404404-PN

Details and patient eligibility

About

The goal of this prospective, multi-centre, randomised controlled clinical study is to evaluate the diagnostic efficacy and safety of nCLE guided lung biopsy in patients with for peripheral lung nodules under the assistance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS), and assess whether the biopsy techniques, namely transbronchial crybiopsy (TBCB) and transbronchial forceps biopsy (TBFB), would influence the diagnostic efficacy and safety of nCLE guided biopsy.

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.

Enrollment: 1,040 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with peripheral lung nodules suspected of lung cancer based on CT scan (10mm≤size<30mm);
• 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

• Inability or non-willingness to provide informed consent;
• 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).

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,040 participants in 4 patient groups

nCLE-NB-rEBUS-forcep biopsy

Experimental group

Description:

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)

Treatment:

Procedure: nCLE-NB-rEBUS-forcep biopsy

nCLE-NB-rEBUS-TBCB

Experimental group

Description:

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)

Treatment:

Procedure: nCLE-NB-rEBUS-TBCB

NB-rEBUS-forcep biopsy

Active Comparator group

Description:

The participants would undergo lung biopsy using forcep, under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)

Treatment:

Procedure: NB-rEBUS-forcep biopsy

NB-rEBUS-TBCB

Active Comparator group

Description:

The participants would undergo transbronchial crybiopsy (TBCB) , under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)

Treatment:

Procedure: NB-rEBUS-TBCB