跳至主要内容
临床试验/NCT04056273
NCT04056273Unknown不适用

Assessment of the Use of Radial Endobronchial Ultrasonography With a Guide Sheath in Increasing the Yield Rate of Transbronchial Lung Biopsy

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 586 人开始时间: 2019年9月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验