Randomized Trial Comparing the Standard and Fanning Techniques for Fine Needle Aspiration of Pancreatic Mass Lesions at Endoscopic Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
Endoscopic Ultrasound (EUS)-guided biopsy is the most ideal technique for evaluating a growth in the pancreas. EUS-guided biopsies yield a definitive diagnosis in greater than 80% of cases. In 15-20% of the cases, a definitive diagnosis cannot be made despite multiple attempts. One of the reasons why a diagnosis cannot be made is due to the focal location of the cancer; i.e., the cancer can be situated in a corner of a big mass and the needle fails to sample the cancer cells. The fanning technique is a method where the needle moves in multiple directions within a mass and therefore there is a better chance of the cancer cells being sampled compared to the standard technique where the needle moves in only one direction. The diagnostic performance of both these techniques has not been compared in a randomized fashion.
详细描述
Fanning technique: Fine Needle Aspiration (FNA) performed in multiple directions within a mass.
Standard technique: FNA performed in unidirectional fashion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 19 years
- •Solid Pancreatic Mass Lesions
排除标准
- •Age < 19 years
- •Coagulopathy
- •Unable to consent
研究组 & 干预措施
Standard
Biopsy using standard technique of FNA
干预措施: Standard (Procedure)
Fanning
Biopsy using fanning technique
干预措施: Fanning (Procedure)
结局指标
主要结局
Diagnostic accuracy
时间窗: 2 months
The number of pancreatic masses that are correctly diagnosed with each needle type
次要结局
- Number of passes for diagnosis(2 months)
研究者
Shyam Varadarajulu
Principal Investigator
University of Alabama at Birmingham
