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临床试验/NCT04448795
NCT04448795已完成不适用

Significance of Drain Amylase Levels After Pancreaticoduodenectomy

Chang Gung Memorial Hospital0 个研究点目标入组 600 人开始时间: 2010年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
600
主要终点
postoperative pancreatic fistula

研究概览

简要总结

This study investigated the impact of highest drain fluid amylase (DFA) level on postoperative pancreatic fistula (POPF) severity and outcomes of patients undergoing pancreaticoduodenectomy (PD) with POPF. Patient demographics of biochemical POPF and clinically relevant POPF (CR-POPF) were compared. Predictive factors were assessed using binary logistic regression. Receiver operating characteristic curve analysis was performed to determine the optimal cutoff value of highest DFA (beyond 3 days post-PD). The investigators compared length of hospital stay, surgical mortality rates, and need for postoperative interventions by highest DFA level.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • underwent PD from October 2010 to September 2018 in our institution

排除标准

  • younger than 20 years of age
  • clinical information was unavailable due to private or legal issues
  • receiving PD without pancreaticojejunostomy

结局指标

主要结局

postoperative pancreatic fistula

时间窗: through study completion, an average of 2 month

fluid output of any measureable volume via an operatively placed drain with amylase activity greater than 3 times the upper normal serum value

次要结局

  • length of hospital stay(through study completion, an average of 2 month)
  • 30-day mortality rates(30 day)
  • postoperative interventions(through study completion, an average of 2 month)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

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