A Randomized Clinical Trial With a New Needle Device Comparing 25G and 22G Needle in Endoscopic Ultrasound Fine-needle Aspiration of Solid Lesions.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Clinical performance of 22G and 25G needles
研究概览
简要总结
Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) is a reliable, safe, and effective technique for obtaining samples from the GI wall lesions and from organs adjacent to the GI tract (pancreas, nodes...).Needles available for EUS-FNA include 25G, 22G and 19G. Some studies have suggested that the 25G needle could be equal or even better than the 22G needle.
The BXN system and neddles are is a newly developed for EUS-FNA. This trial is developed for testing the accuracy of the new neddle system for EUS-FNA and for comparing the two needles types, 25G and 22G.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •endosonographic appearance of a solid lesions
- •age >18 years
- •informed consent.
排除标准
- •alteration of the coagulation (INR >1.5, PLT <50 x 103 /µL)
- •inability to express consent
结局指标
主要结局
Clinical performance of 22G and 25G needles
时间窗: 18 months
Evaluation of whether enough material for adequate cytological/histological analysis can obtained with equal efficacy with the 25G and the 22G needles. The percentages of adequate samples obtained.
次要结局
- Number of crossovers(18 months)
- Major complications(18 months)
- Needle malfunction(18 months)
- Ease of needle pass(18 months)
- Number of passes(18 months)
研究者
Michele Tedeschi
MD
Istituto Clinico Humanitas