Randomised Controlled Trail of Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy After Pancreaticoduodenectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- pancreatic fistula
研究概览
简要总结
The purpose of this study is to determine whether duct-to-mucosa is better than invagination in pancreaticojejunostomy after pancreaticoduodenectomy. This single-centre, open, randomized controlled trail is conducted following ISGPF criteria for pancreatic fistula (PF). The duration of the study is supposed to start from Jan 5th 2012 and last to Dec 2014, until 100 or more cases are accessible. Patients diagnosed with pancreatic cancer, peri-ampullar carcinoma or other benign or malignant diseases which need to operate pancreaticoduodenectomy will be included. Main outcomes are pancreatic fistula rate, mortality, morbidity, reoperation and hospital stay. The investigators assumption that duct-to-mucosa is better than invagination.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with pancreatic cancer or other diseases which need pancreaticoduodenectomy and pancreaticojejunostomy
- •18 to 80 y/o
- •Operation-tolerated
- •Informed consent
排除标准
- •History of gastrointestinal operation
- •Pancreaticoduodenectomy is given up during operation
- •Pancreatic duct is difficult to locate
- •Patients require to exit from the study anytime
结局指标
主要结局
pancreatic fistula
时间窗: From date of operation until the date of dischage or date of death from any cause, whichever came first,, assessed up to 200 days
The determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria.
次要结局
- Mortality(From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days)
- Morbidity(From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days)
- Reoperation(From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days)
- Hospital stay(From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days)
研究者
TingBo Liang
The Second Affiliated Hospital, School of Medicine, Zhejiang Universtiy
Zhejiang University