Assessment of the Use of Radial Endobronchial Ultrasonography With a Guide Sheath in Increasing the Yield Rate of Transbronchial Lung Biopsy
试验速览
- 阶段
- 不适用
- 入组人数
- 586
- 试验地点
- 2
- 主要终点
- The diagnostic yield rate i. Brushing cytology ii. Biopsy
研究概览
简要总结
Whether using a guide sheath can increase the diagnostic yield rate after the lesion is located by radial endobronchial ultrasound
详细描述
For lung nodules, there are several ways to acquire tissue for pathology study, including computed tomography (CT)-guided core needle biopsy, radial probe endobronchial ultrasound (rEBUS)-guided transbronchial lung biopsy (TBLB), convex probe EBUS transbronchial needle aspiration (TBNA), and echo-guided core needle biopsy. rEBUS-guided TBLB has relatively low limitation of lesion position, comparing to echo-guided core needle biopsy and EBUS-TBNA, and doesn't need to deal with the risk of radiation exposure.1 For peripheral pulmonary lesions (PPL), it has good yield rate and the operation is easy.2 However, when bleeding occurs, the procedure time is prolonged for hemostasis. Nonetheless, using a guide sheath can help with the problem. According to the literatures, biopsy yield rates vary but on average it is higher with a guide sheath (62~90% vs. 41~73%), while the complication rates are about the same (1.3~4.4% 1.5~5.0%). The investigators would like to know whether the diagnostic rate is higher with a guide sheath and so do the procedure time and the complication rate. Whether the lesion character affect the yield rate will also be studied.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 years old. Radiographic evidence of peripheral pulmonary lesions. The lesion can be located by radial probe EBUS.
排除标准
- •B1 bronchus. Thrombocytopenia with platelet count < 100K. Coagulopathy with INR > 1.
- •High oxygen demand (O2 mask > 28%, 5L). Currently using anti-platelet drug or anti-coagulant.
结局指标
主要结局
The diagnostic yield rate i. Brushing cytology ii. Biopsy
时间窗: 2 years
The diagnostic yield rate of transbronchial biopsy and brushing cytology by using guide sheath
次要结局
- Complication rate (pneumothorax, hemoptysis)(1 year)
- Procedure duration(1 year)
