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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,040
- 试验地点
- 1
- 主要终点
- diagnostic yield of lung forcep biopsy and TBCB under guidance of nCLE-NB-rEBUS
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
diagnostic yield of lung forcep biopsy and TBCB under guidance of nCLE-NB-rEBUS
时间窗: 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
时间窗: 7 days after the biopsy
The proportion of participants of lung cancer in whom the biopsy led to a definitive diagnosis .
次要结局
- Incidence rate of adverse events(7 days after the biopsy)
- the adequacy of sample acquisition(7 days after the biopsy)
研究者
Gang Hou
Professor
China-Japan Friendship Hospital