Evaluation of the Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Number of Participants With Delayed Gastric Emptying as Measured by Modified Accordion Grading System (MAGS)
研究概览
简要总结
The purpose of this study is to prospectively determine the effects of administering proton pump inhibitors (PPIs) following pancreaticoduodenectomy on postoperative outcomes. The findings of this study will help in avoiding the widespread use of PPIs during the immediate postoperative period following pancreatic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive patients who will undergo pancreaticoduodenectomy with gastric/biliary reconstruction performed as definitive management for a benign or malignant disease at Washington University/Barnes-Jewish Hospital.
- •At least 18 years of age.
- •Ability to understand and willingness to sign an IRB approved written informed consent document.
排除标准
- •<18 years of age
研究组 & 干预措施
Placebo
-Visually equivalent placebo once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier).
干预措施: Placebo (Drug)
Proton pump inhibitor
-Pantoprazole once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier).
干预措施: Pantoprazole (Drug)
结局指标
主要结局
Number of Participants With Delayed Gastric Emptying as Measured by Modified Accordion Grading System (MAGS)
时间窗: Through 90 days after surgery
-Will be coded as yes and no
Number of Participants With Delayed Gastric Emptying as Measured by the International Study Group of Pancreatic Surgery (ISGPS) Criteria
时间窗: Through 90 days after surgery
-Will be coded as yes and no
次要结局
- Number of Participants With Surgical Complication(s) Defined by the Modified Accordion Grading System (MAGS)(Through 90 days after surgery)
- Kaplan-Meier Estimated 90-days Marginal Ulcer-free Survival (MUFS) Probability(Through 90 days after surgery)