A Single-arm, Prospective, Multicenter, Real-world Study to Evaluate the Safety and Efficacy of Bronchoscopic Transparenchymal Nodule Access (BTPNA) for the Diagnosis of Peripheral Lung Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Diagnostic yield
研究概览
简要总结
The study is designed as a multicenter prospective trial of BTPNA for the diagnosis of peripheral pulmonary lesions in the real world. The purpose of the study is to evaluate the safety and effectiveness of BTPNA and to explore the factors of diagnosis rate.
详细描述
The study will be conducted at about 10 clinical centers. Patients will be first screened, and only after meeting all the selection criteria, not meeting any exclusion criteria, and signing the informed consent, could they be enrolled in the group to receive BTPNA to sample the target lesions. The primary endpoint is the diagnostic yield of BTPNA. The secondary endpoints include the success rate of navigation, the operation time of the bronchoscope and so on.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years old.
- •Newly diagnosed patients whose chest CT shows peripheral pulmonary lesions that have bronchus signs but are difficult to reach through the intrabronchial path, or are adjacent to the airway, or have no bronchus sign, and are suspected of malignancy which need non-surgical biopsies.
- •The diameter of the lesions is greater than or equal to 0.8cm and less than 5cm
- •The location of lesions results in the following situations where transthoracic needle aspiration (TTNA) is difficult to obtain a diagnosis or the operation is relatively risky, or have not been diagnosed by TTNA and other non-surgical biopsies in the past.
- •Lesions can be accessed by BTPNA technology in preoperative assessment.
- •Understand the research and sign the informed consent form.
排除标准
- •Contraindications for bronchoscopy.
- •The lesions are adjacent to the target trachea or bronchus of points of entry(POE).
- •Severe cardiopulmonary dysfunction and other diseases that may significantly increase the risk of surgery.
- •Routine bronchoscopy showed visible lesions in the lumen.
- •The investigator believes that the patient has other conditions that are not suitable for inclusion in this study.
结局指标
主要结局
Diagnostic yield
时间窗: Six months
Diagnostic yield is defined as the proportion of lesions diagnosed by BTPNA in all lesions undergoing bronchoscopy biopsy by BTPNA.
次要结局
- The total time of lesion access(Immediately after bronchoscopic biopsy)
- The intraoperative fluoroscopy time(Immediately after bronchoscopic biopsy)
- Factors affecting the navigation success rate(Six months)
- The operation time of the bronchoscope(Immediately after bronchoscopic biopsy)
- The success rate of navigation(Immediately after bronchoscopic biopsy)
- Factors affecting the biopsy success rate(Six months)
- The success rate of biopsy(Immediately after bronchoscopic biopsy)
- Factors affecting the diagnosis rate(Six months)
研究者
Jiayuan Sun
Director, Department of Respiratory Endoscopy
Shanghai Chest Hospital