EUS-guided Fine Needle Tissue Acquisition of Solid Pancreatic Mass Lesions Using a Novel Corkscrew Technique: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Number of Participants With Adverse Events as a Measure of Safety
研究概览
简要总结
This research is being done to investigate if a new technique to biopsy the pancreas will lead to a larger amount tissue material that can be analyzed. Investigators have called the technique the "corkscrew" technique and believe it will allow obtaining a larger biopsy sample during the endoscopic ultrasound examination. The corkscrew technique uses a clockwise rotational movement to drive the needle into the pancreatic mass (like a wine bottle opener twists and buries itself into a cork). It is believed that this will lead to a better biopsy sample than the usual way and therefore result in a higher chance of a diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In-patients and out-patients between the age of 18 and 90 years with solid pancreatic masses presenting for EUS-Fine Needle Aspiration (FNTA)
排除标准
- •Uncorrectable coagulopathy (INR > 1.5)
- •Uncorrectable thrombocytopenia (platelet < 50,000)
- •Uncooperative patients
- •Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures)
- •Refusal to consent form
- •Prior negative FNTA
- •In situ metallic biliary stents
- •Predominantly cystic lesions
- •Inaccessible lesions to EUS
研究组 & 干预措施
Pancreatic mass
Patients with pancreatic mass presenting for EUS-FNA
干预措施: EUS-FNA with Corkscrew technique (Procedure)
Pancreatic mass
Patients with pancreatic mass presenting for EUS-FNA
干预措施: Expect 19 G Flex needle (Device)
结局指标
主要结局
Number of Participants With Adverse Events as a Measure of Safety
时间窗: 30 days
次要结局
- Diagnostic Yield of the FNA Using Corkscrew Technique(30 days)