NCT03314337已完成不适用
A Prospective Randomized Controlled Study Comparing Outcomes of Distal Pancreatectomy With or Without Pancreatic Stent
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- all-cause mortality / complications
研究概览
简要总结
The purpose of this study is to compare outcomes of patients undergoing distal pancreatectomy with or without pancreatic stent
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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 undergoing distal pancreatectomy
- •Signed the informed consents
排除标准
- •Recurrence patients
- •pre-operative anti-cancer treatment
- •patients with contraindication(hepatic/ respiratory/ renal dysfunction, etc )
- •AJCC stage IV
- •pre operative oddi'ssphincter incision
- •operation non radical
- •pancreatic stent not at place
研究组 & 干预措施
Distal Pancreatectomy without pancreatic stent
No Intervention
Distal Pancreatectomy with pancreatic stent
Experimental
pancreatic stent will be placed in the main pancreatic duct during the operation
干预措施: Pancreatic stent: PSOF COOK® (Device)
结局指标
主要结局
all-cause mortality / complications
时间窗: Hospitalization 30days（duration of hospital stay)
mortality, pancreatic fistula, Biliary fistula，bleeding， etc
次要结局
- all-cause mortality / complications(30 days after operation)
研究者
研究点 (1)
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