Study on the Effectiveness and Safety of Confocal Laser Endomicroscopy Combined With Ultrafine Cryoprobe for Biopsy Diagnosis of Pulmonary Lesions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
研究概览
简要总结
Forty subjects meeting the inclusion and exclusion criteria were recruited at a single center and signed informed consent forms. Among them, 20 patients in the diffuse group and 20 patients in the localized group were randomly assigned to the conventional radial endobronchial ultrasound combined with cryobiopsy group (conventional group) and the confocal laser endomicroscopy combined with cryobiopsy group (combined group). During the operation, the operator manipulated the bronchoscope to reach the lesion. After confirming the arrival at the lesion using radial endobronchial ultrasound/confocal laser endomicroscopy, cryobiopsy was performed, and the size of the sample was recorded. CBCT scanning was conducted after cryobiopsy. If there was no hole-in-lesion image, cryobiopsy was performed again under CBCT guidance. CBCT scanning was performed after biopsy to determine whether there were any adverse events.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old with lung lesions indicated by chest CT;
- •Preoperative CT indicates that the lung lesion to be biopsied has a bronchus leading to it;
- •Able to understand and voluntarily sign the written informed consent form. -
排除标准
- •Patients with contraindications to anesthesia or bronchoscopy;
- •Patients with uncorrectable coagulation disorders;
- •Patients who cannot discontinue therapeutic anticoagulants within an appropriate time interval before surgery;
- •Patients with severe liver or kidney dysfunction, mental illness, etc.;
- •Pregnant or lactating patients;
- •Patients without a clear histological or clinical diagnosis;
- •Subjects deemed unsuitable for participation in this study by the investigator.
研究者
Li Shiyue
professor
Guangzhou Medical University