Application of Three-Dimensionally Printed Navigational Template in Percutaneous Transthoracic Lung Biopsy: A Prospective, Randomized, Controlled, Noninferiority Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Diagnostic yield of percutaneous transthoracic fine-needle aspiration
研究概览
简要总结
This is a prospective, randomized, controlled study to evaluate the diagnostic yield and safety of three-dimensionally printed navigational template in percutaneous transthoracic lung biopsy.
详细描述
The feasibility of three-dimensionally printed navigational template-guided percutaneous transthoracic fine-needle aspiration was validated by a phase I study. To further investigate the non-inferiority of navigational template-guided lung biopsy to conventional CT-guided modality in terms of diagnostic yield, this prospective, randomized, controlled, noninferiority trial was conducted.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ⅰ. Inclusion Criteria:
- •A. CT confirmed peripheral lung lesion;
- •B. Nodule size larger than or equal to 30 mm;
- •C. Scheduled for percutaneous transthoracic fine-needle aspiration;
- •D. Percutaneous transthoracic lung biopsy was conducted at supine or partially lateral decubitus;
- •E. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2;
- •F. Written informed consent provided.
排除标准
- •A. Biopsy needle insertion route impeded by skeletal structures;
- •B. Lesion within 3 cm above diaphragmatic dome;
- •C. Insertion route longer than the biopsy needle;
- •D. Lung biopsy needed to be conducted at vertically lateral decubitus;
- •E. Any contraindication of percutaneous transthoracic lung biopsy;
- •F. Women who are pregnant or in the period of breastfeeding.
结局指标
主要结局
Diagnostic yield of percutaneous transthoracic fine-needle aspiration
时间窗: Three to four working days post-biopsy were needed to establish the diagnosis of the cytological specimens acquired by fine-needle aspiration.
A percutaneous transthoracic fine-needle aspiration procedure was considered diagnostic if a malignant or specific benign diagnosis of the lesion was made. The ratio of diagnostic cases to all the participants who received the corresponding biopsy was considered as diagnostic yield.
次要结局
- Radiation exposure(15 mins post biopsy)
- Diagnostic sensitivity of percutaneous transthoracic fine-needle aspiration(If an eventual diagnosis was attained by means of follow-up, a 12-month assessment was needed.)
- Complication rate(Real-time complication post biopsy indicates those recognized by the immediate CT scan, while delayed complication indicates those recognized by radiograph taken 4-6 hours post biopsy.)
- Procedural duration(15 mins post biopsy)
研究者
Chang Chen
Prof. Dr.
Shanghai Pulmonary Hospital, Shanghai, China