跳至主要内容
临床试验/NCT00471627
NCT00471627Unknown1 期

New Type of a Pancreaticojejunostomy - a Pilot Study

Tampere University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2006年12月最近更新:
适应症

试验速览

阶段
1 期
入组人数
30
试验地点
2
主要终点
Pancreatic fistula, other complications

研究概览

简要总结

Previously we have demonstrated in animal experiments,that pancreas is extremely vulnerable to handling, reacting with the development of pancreatitis. In human pancreatic surgery, post-operative pancreatitis mediates many other post-operative complications. A new anastomosis was developed to diminish the injury, as being without any stitches going through the pancreas. The aims were to study up to 30 patients as phase one study, with an interim analysis in this open uncontrolled trial after the first few patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled to undergo peancreatic head resection

排除标准

  • Those who refuse from the study

结局指标

主要结局

Pancreatic fistula, other complications

时间窗: One year from operation

次要结局

  • Patency of the pancreaticojejunostomy(One year)

研究者

申办方类型
Other

研究点 (2)

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