NL-OMON53986招募中不适用
CLE-guided bronchoscopy for peripheral lung cancer diagnosis: a Randomized Controlled Trial - Confocal Laser Endomicroscopy Verification (CLEVER)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •>=18 years of age
- •Suspected malignant peripheral lung lesion with an indication for a
- •bronchoscopic diagnostic work-up
- •Solid part of the lesion must be >10 mm
- •Largest dimension of lesion size on CT equal to or less than 30 mm
- •Bronchus sign on pre-procedural CT or estimated confidence for successful
- •navigation to the nodule resulting in a r-EBUS signal
- •Ability to understand and willingness to sign a written informed consent
排除标准
- •Inability or non-willingness to provide informed consent
- •Patients with an endobronchial visible lung tumor on bronchoscopic inspection
- •Patients in which the target lesion is within reach of the linear EBUS scope
- •Failure to comply with the study protocol
- •Patients with known allergy for fluorescein or risk factors for an allergic
- •Pregnant or breastfeeding women
- •Patients with hemodynamic instability
- •Patients with refractory hypoxemia
- •Patients with a therapeutic anticoagulant that cannot be held for an
- •appropriate interval before the procedure
- •Patients who are unable to tolerate general anesthesia according to the
- •anesthesiologist
- •Patient undergoing chemotherapy as several chemotherapies have fluorescent
- •properties at the same wavelength (e.g. doxorubicin)
- •Inability to follow-up
研究者
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