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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06739421
• Lead Sponsor: China-Japan Friendship Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18
• Study Start: 2025-01-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1040

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
diagnostic yield of lung forcep biopsy and TBCB under guidance of nCLE-NB-rEBUS	7 days after the biopsy	The proportion of participants in whom the biopsy led to a definitive diagnosis.
Sensitivity of lung forcep biopsy and TBCB under guidance of nCLE-NB-rEBUS	7 days after the biopsy	The proportion of participants of lung cancer in whom the biopsy led to a definitive diagnosis .

Secondary Outcome Measures

Name	Time	Method
Incidence rate of adverse events	7 days after the biopsy	Symptoms and signs
the adequacy of sample acquisition	7 days after the biopsy	Samples resulting in a specific diagnosis or samples with the presence of lymphpcytes were considered as adequate.

Trial Locations

Locations (1)

China-Japan Friendship Hospital, , 100029; 🇨🇳 Beijing, Beijing, China