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临床试验/NCT01023594
NCT01023594Unknown不适用

Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy: Prospective Randomized Study

Seoul National University Hospital14 个研究点 分布在 1 个国家目标入组 328 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
328
试验地点
14
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

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sun-Whe Kim

Professor

Seoul National University Hospital

研究点 (14)

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