Biliary Drainage Preceding Possible Pancreaticoduodenectomy. Are Self-expandable Metallic Stents (SEMS) Superior to Plastic Stents?
This study looks in to the rate of biliary stent dysfunction for plastic and metallic stents in patients who need biliary drainage due to a tumor in pancreas before possible pancreaticoduodenectomy. Complications related to the biliary decompression, and possible post-surgical complications in all patients are also recorded.
This trial aims to confirm whether metallic biliary stents really are superior to plastic stents as some previous studies suggest. Specific patient groups are also evaluated individually to see, whether patients with ongoing cholangitis at the time of diagnosis or patients receiving neoadjuvant treatments have less stent dysfunction cases and complications with metallic stents than with plastic stents.
研究概览
研究类型
阶段
- 不适用
联系人和位置
学习地点
-
-
Uusimaa
-
Helsinki、Uusimaa、芬兰、00029
- Helsinki University Hospital
-
-
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
描述
Inclusion Criteria:
- Resectable tumor of the head of the pancreas
- Elevated serum bilirubin levels
- Radiologically visible dilatation of the biliary system
Exclusion Criteria:
- Distant metastasis
- Inoperable tumor or other reason, why the patient is unfit for surgery
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Plastic biliary stent
A plastic (ie Tannenbaum 10 Fr) biliary stent is used to achieve biliary decompression
|
Tannenbaum 10 Fr biliary stent
|
|
实验性的:Self-expandable metallic biliary stent
A self-expandable metallic biliary stent is used to achieve biliary decompression
|
ie WallFlex biliary RX
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Stent failure rate, and need for re-procedure before pancreaticoduodenectomy.
大体时间:Evaluation at the day of pancreatic surgery
|
Evaluation at the day of pancreatic surgery
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Other complications related to preoperative biliary decompression, and post-surgical complications
大体时间:Complication emerged within 120 days from pancreaticoduodenectomy
|
Complication emerged within 120 days from pancreaticoduodenectomy
|
合作者和调查者
调查人员
- 首席研究员:Leena Kylänpää, MD, PhD、Helsinki University Central Hospital
出版物和有用的链接
一般刊物
- Decker C, Christein JD, Phadnis MA, Wilcox CM, Varadarajulu S. Biliary metal stents are superior to plastic stents for preoperative biliary decompression in pancreatic cancer. Surg Endosc. 2011 Jul;25(7):2364-7. doi: 10.1007/s00464-010-1552-6. Epub 2011 Mar 4.
- Haapamaki C, Seppanen H, Udd M, Juuti A, Halttunen J, Kiviluoto T, Siren J, Mustonen H, Kylanpaa L. Preoperative biliary decompression preceding pancreaticoduodenectomy with plastic or self-expandable metallic stent. Scand J Surg. 2015 Jun;104(2):79-85. doi: 10.1177/1457496914543975. Epub 2014 Jul 15.
- Velanovich V, Kheibek T, Khan M. Relationship of postoperative complications from preoperative biliary stents after pancreaticoduodenectomy. A new cohort analysis and meta-analysis of modern studies. JOP. 2009 Jan 8;10(1):24-9.
研究记录日期
研究主要日期
学习开始 (实际的)
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 (实际的)
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
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