NCT00855985Unknown不适用
A Randomised Controlled Trial of Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Pancreaticoduodenectomy for Cancer
Lakeshore Hospital2 个研究点 分布在 1 个国家目标入组 312 人开始时间: 2004年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 312
- 试验地点
- 2
- 主要终点
- pancreatic fistula rate
研究概览
简要总结
There are two principal ways of draining the remnant of the pancreas back into the intestine after removal of the head of the pancreas for cancer. This can be performed either to the jejunum or to the stomach. The aim of this study is to randomly allocate consenting patients to one of the two arms to study whether the leak rates from the anastomosis and the outcomes after the surgery are affected.
Previous papers have shown similar results in both groups although non randomized data suggested that the Pancreaticogastrostomy (drainage into the stomach) may be superior
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pancreaticoduodenectomy for adenocarcinoma of the pancreatic head
- •resectable tumour
排除标准
- •chronic pancreatitis/benign tumours-
- •tumours extending into the body of the pancreas
- •tumours with metastasis beyond regional lymph nodes
- •requirement for sub total pancreatectomy
- •prolonged hypotension - < 80 mm of hg for more than 30 min
结局指标
主要结局
pancreatic fistula rate
时间窗: 30 days
次要结局
- mortality(90 days)
- Hospital stay(90 days)
- need for postoperative intervention(90 days)
- major complication(90 days)
研究者
Dr H Ramesh
Director of Surgical Gastroenterology
Lakeshore Hospital
研究点 (2)
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