Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy: Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 入组人数
- 328
- 试验地点
- 8
- 主要终点
- evidence of pancreatic fistula confirmed by serum and drain amylase
研究概览
简要总结
Pancreatic fistula is one of the most serious complication after pancreatoduodenectomy. To reduce pancreatic fistula, many authors recommend pancreatic stent in pancreatojejunostomy. There are two distinct methods of pancreatic stent insertion: internal stent and external stent. There was few studies comparing these methods in preventing pancreatic fistula. Furthermore, its long-term effect was not known enough. The purpose of this study is to determine which is the best method in preventing pancreatic fistula and to investigate its long term clinical outcomes.
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
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient who have malignant or benign disease which needs pancreatoduodenectomy
- •patient age: ≥20 and ≤85
排除标准
- •patient who had chemotherapy or radiotherapy previous to operation.
- •patient who had severe comorbid disease(cardiac, pulmonary, cerebrovascular)
- •patient who had past medical history of chronic pancreatitis.
- •pancreatic stent size <1mm or >5mm
研究组 & 干预措施
External stent
Feeding tube insert at pancreatojejunostomy site as a stent. And stent tube is brought out through jejunal loop below the hepaticojejunostomy site and abdominal wall.
干预措施: Pancreatic stent (Procedure)
Internal stent
short(5cm)internal stent insertion at pancreatojejunostomy site
干预措施: Pancreatic stent (Procedure)
结局指标
主要结局
evidence of pancreatic fistula confirmed by serum and drain amylase
时间窗: within the first 7 days after surgery
次要结局
- pancreatic endocrine and exocrine function by blood test, stool exam (steatorrhea) and computed tomography (CT) volumetry(within the first 1 year after surgery)
研究者
Sun-Whe Kim
Professor
Seoul National University Hospital