NCT00471627Unknown1 期
New Type of a Pancreaticojejunostomy - a Pilot Study
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
- 否
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
研究点 (2)
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