Serum Parameter Prior and After EUS-guided Fine Needle Aspiration of the Pancreas
Serum Lipase, Amylase and CA 19-9 Prior and After EUS-guided Fine Needle Aspiration of the Pancreas
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.
研究概览
研究类型
注册 (预期的)
联系人和位置
学习地点
-
-
Lower Saxony
-
Göttingen、Lower Saxony、德国、37075
- 招聘中
- Department of Gastroenterology, University Medical Center
-
Northeim、Lower Saxony、德国、37154
- 招聘中
- HELIOS Albert-Schweitzer Hospital Northeim
-
-
North-Rhine Westphalia
-
Bielefeld、North-Rhine Westphalia、德国、33604
- 招聘中
- Department of Gastroenterology, Klinikum Bielefeld
-
接触：
- Jan Heidemann, PD Dr.
- 电话号码：+495215813451
- 邮箱：info@klinikumbielefeld.de
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- independent indication for pancreatic EUS-FNA
- age ≥ 18 years
- patient able to give informed consent
Exclusion Criteria:
- Contraindications for EUS-FNA
- pregnancy
- no informed consent available
- known stenosis of esophagus or duodenum
- relevant coagulation disorders
学习计划
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
FNA, blood collection
blood collection prior to fine needle aspiration Endoscopic ultrasonography-guided fine needle aspiration of the pancreas blood collection after to fine needle aspiration
|
blood will be taken for assessment of serum lipase, serum amylase and CA 19-9 prior to EUS-FNA
During endoscopic ultrasonography, fine needle aspiration will be performed for cytological analysis of the pancreas
blood will be taken 4h after EUS-FNA for assessment of serum lipase, serum amylase and CA 19-9
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Serum lipase
大体时间：up to 24h prior to EUS-FNA and 4 hours after EUS-FNA
|
up to 24h prior to EUS-FNA and 4 hours after EUS-FNA
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Serum amylase
大体时间：up to 24 hours prior to EUS-FNA
|
up to 24 hours prior to EUS-FNA
|
|
Serum amylase
大体时间：4 hours after EUS-FNA
|
4 hours after EUS-FNA
|
|
CA 19-9
大体时间：up to 24 hours prior to EUS-FNA
|
up to 24 hours prior to EUS-FNA
|
|
CA 19-9
大体时间：4 hours after EUS-FNA
|
4 hours after EUS-FNA
|
合作者和调查者
调查人员
- 首席研究员：Tobias Meister, PD Dr.、HELIOS Albert-Schweitzer-Klinik
- 首席研究员：Jan Heidemann, PD Dr.、Klinikum Bielefeld
- 首席研究员：Volker Ellenrieder, Prof. Dr.、University Medical Center Göttingen
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.