Lung Cancer, Non-Small Cell, Lung Cancer, Small Cell
Conditions
Keywords
needle-based confocal laser endomicroscopy, peripheral lung cancer, peripheral lung nodules, lung biopsy
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.
Interventions
PROCEDUREnCLE-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)
PROCEDUREnCLE-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)
PROCEDURENB-rEBUS-forcep biopsy
The participants would undergo lung biopsy using forcep, under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
PROCEDURENB-rEBUS-TBCB
The participants would undergo transbronchial crybiopsy (TBCB), under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactHou Gang, MD
Backup ContactDeng Mingming, MD
Outcome results
None listed