Observational Participants Not Assigned to Intervention(s) Based on a Protocol; Typically in Context of Routine Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
This study is designed to evaluate complications, specificity, diagnostic yield of radial endobronchial ultrasound guided transbronchial cryobiopsy and transbronchial forceps biopsy with fluoroscopy in the diagnosis of peripheral pulmonary lesion; the interplay between non-small-cell lung cancer associated-bacteria along the gut-lung axis and immune response in the cancer microenvironment.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with peripheral lung lesion suspected of lung cancer detected on the chest computed tomography (CT) and RP-EBUS scans
- •Control group - patients without non-small cell lung cancer
- •Written (signed) Informed Consent to participate in the study
排除标准
- •severe hypoxemia (partial pressure of oxygen (pO2)< 60 mmHg) or hypercapnia (carbon dioxide partial pressure (pCO2)> 50 mmHg),
- •bleeding disorders
- •The diffusing capacity for carbon monoxide (DLCOc)< 35 %,
- •forced expiratory volume in one second (FEV1) < 800 ml or FEV 1 < 30 %,
- •peripheral lung tumor was not visualised by RP-EBUS longer than 30 minutes
- •large vessels (more than 3 mm) near the tumor on the CT scan,
- •technically difficult to introduce cryoprobe and/or endobronchial blocker to current bronchi segment or subsegment,
- •excessive bleeding after transbronchial forceps biopsy, which was needed extra intervention to stop bleeding.
研究组 & 干预措施
Transbronchial forceps biopsy
Patients, whose transbronchial forceps biopsy was performed
干预措施: Transbronchial forceps biopsy (Diagnostic Test)
Transbronchial forceps biopsy+Transbronchial cryobiopsy
Patients, whose transbronchial forceps biopsy and transbronchial cryobiopsy were performed as well
干预措施: Transbronchial forceps biopsy+Transbronchial cryobiopsy (Diagnostic Test)
结局指标
主要结局
progression-free survival
时间窗: one year after enrolment to the study
次要结局
- overall survival(3 years after enrolment to the study)
研究者
Marius Zemaitis
Professor
Lithuanian University of Health Sciences