Clinical trial NCT06739421: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Cancer, Non-Small Cell
Lung Cancer, Small Cell
Keywords: needle-based confocal laser endomicroscopy
peripheral lung cancer
peripheral lung nodules
lung biopsy
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 1040
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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).

Primary outcomes:
measure: diagnostic yield of lung forcep biopsy and TBCB under guidance of nCLE-NB-rEBUS
timeFrame: 7 days after the biopsy
measure: Sensitivity of lung forcep biopsy and TBCB under guidance of nCLE-NB-rEBUS
timeFrame: 7 days after the biopsy
Secondary outcomes:
measure: Incidence rate of adverse events
timeFrame: 7 days after the biopsy
measure: the adequacy of sample acquisition
timeFrame: 7 days after the biopsy
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital, , 100029
state: Beijing
Study officials:
References: