Not Yet RecruitingNot Applicable

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

China1,040 participantsStarted 2025-01-01

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

diagnostic yield of lung forcep biopsy and TBCB under guidance of nCLE-NB-rEBUS

Timeframe: 7 days after the biopsy

Sensitivity of lung forcep biopsy and TBCB under guidance of nCLE-NB-rEBUS

Timeframe: 7 days after the biopsy

Trial details

NCT IDNCT06739421

SponsorChina-Japan Friendship Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

Contact for this trial

Hou Gang, MD

010-84205729 hougangcmu@163.com