Serum Lipase, Amylase and CA 19-9 Prior and After EUS-guided Fine Needle Aspiration of the Pancreas
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 208
- 试验地点
- 3
- 主要终点
- Serum lipase
研究概览
简要总结
Endoscopic ultrasonography (EUS ) -guided fine needle aspiration (EUS -FNA ) of focal pancreatic lesions is an essential diagnostic procedure with high therapeutic effect in clinical routine.
The aim of this study is to determine the levels of serum lipase, serum amylase and the tumor marker CA 19-9 prior and after EUS-FNA. In animal experiments on dogs, an increase of all three parameters was observed after surgery on the pancreas. For humans, these clinically important data are not yet available .
It is assumed that the probability of pancreatitis with increased activity of lipase and amylase will rise with the number of puncture procedures as well as the size of the puncture needle. In addition, the post-interventional assessment of the tumor marker CA 19-9 could result in a false positive assumption of malignant neoplastic pancreatic lesion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •independent indication for pancreatic EUS-FNA
- •age ≥ 18 years
- •patient able to give informed consent
排除标准
- •Contraindications for EUS-FNA
- •pregnancy
- •no informed consent available
- •known stenosis of esophagus or duodenum
- •relevant coagulation disorders
结局指标
主要结局
Serum lipase
时间窗: up to 24h prior to EUS-FNA and 4 hours after EUS-FNA
次要结局
- CA 19-9(4 hours after EUS-FNA)
- Serum amylase(4 hours after EUS-FNA)