NCT05804786招募中不适用
Korean Multicenter Prospective Cohort of Diagnostic Bronchoscopy for Peripheral Lung Lesions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,240
- 试验地点
- 11
- 主要终点
- Diagnostic yield at index
研究概览
简要总结
The primary objective is To evaluate the usefulness and safety of advanced guided bronchoscopy for histological diagnosis of peripheral pulmonary lesions.
The Secondary objective is to establish a strategy that can most effectively use endoscopes for early diagnosis of lung cancer in a real-world care environment by identifying patient/clinical/image/procedure-related characteristics that can optimize the practicality of emerging technologies.
详细描述
- Patients with peripheral pulmonary lesions who need histological diagnosis due to suspected lung cancer and whose lesions are judged capable of histological examination through guided bronchoscopy will be prospectively recruited.
- This study is a pure non-interventional pragmatic design. In addition to biopsy for lung lesions using bronchoscopy, lung cancer staging and tests necessary for metastases and treatment for diagnosed lung cancer are performed according to existing guidelines and the judgment of medical staff.
- We will analyze the clinical characteristics of guided bronchoscopy procedures used in clinical practice and the main results during the follow-up period of up to one year (diagnostic yield, sensitivity, safety, practicality, and various factors affecting usefulness).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who agreed in writing to participate in this study
- •Adult men and women over 19 years of age
- •Patients who visited the hospital with lung lesions suspected of lung cancer and require a diagnostic biopsy
- •Patients capable of biopsy through guided bronchoscopy
排除标准
- •Patients who are unable to express their opinions and cannot cooperate due to a lack of cognitive function
结局指标
主要结局
Diagnostic yield at index
时间窗: Upon reports of pathologic results (up to 2 weeks after bronchoscopy)
The proportion of pathologic results that leads to a specific malignant or benign
次要结局
- Diagnostic accuracy at 12 months(Confirmed by follow-up results at 1 year)
- Sensitivity for malignancy(Confirmed by follow-up results at 1 year)
- Complication(Confirmed by follow-up results at 1 year)
研究者
Yeon Wook Kim
Professor
Seoul National University Bundang Hospital
研究点 (11)
Loading locations...
相似试验
Unknown
不适用
Transbronchial Ablation for Peripheral Lung TumorLung CancerNCT02972177Shanghai Chest Hospital60
尚未招募
不适用
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 TrialLung Cancer, Non-Small CellLung Cancer, Small CellNCT06739421China-Japan Friendship Hospital1,040
Unknown
不适用
Bronchoscopy in Lower Respiratory Tract Infection in Respiratory Intensive Care UnitLower Respiratory Tract InfectionNCT03846401Assiut University100
已完成
不适用
High Definition bronchoscopy, an exploratory study of diagnostic value in comparison to standard white light bronchoscopy and autofluorescence bronchoscopyhead and neck cancer100386661002910710038737lung cancerNL-OMON35123niversitair Medisch Centrum Sint Radboud29
终止
不适用
Study of Different Etiologic Diagnostic Methods in Ventilator Associated Pneumonia (VAP)Ventilator Associated PneumoniaNCT02363023Federal University of Uberlandia30