Pancreaticoduodenectomy With or Without Braun Enteroenterostomy: Comparison of Postoperative Pancreatic Fistula and Delayed Gastric Emptying
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 341
- 试验地点
- 2
- 主要终点
- Decreased rates of pancreatic fistula in surgeries adding Braun enteroenterostomy
研究概览
简要总结
The investigators plan to perform a prospective randomized, head-to-head trial to test the hypothesis that the addition of Braun enteroenterostomy to standard pancreaticoduodenectomy (PD) reconstruction can decrease the rates of Postoperative Pancreatic Fistula (POPF) and/or Delayed Gastric Emptying (DGE).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients undergoing pancreaticoduodenectomy surgery at Johns Hopkins Hospital
排除标准
- •Pregnant women
- •Patients under the age of 18
- •adults lacking ability to consent,
- •patients scheduled for laparoscopic whipple surgery
- •non-english-speakers, and
- •prisoners
结局指标
主要结局
Decreased rates of pancreatic fistula in surgeries adding Braun enteroenterostomy
时间窗: patients will be followed during hospital stay and interviewed at 90 days +/- 2 weeks post surgery
patients will be assessed for post operative fistula and delayed gastric emptying during hospitalization and then interviewed at 90 days +/- 2 weeks from OR date to assess any unanticipated consequences after discharge. We are currently performing statistical analysis of outcome data on the first 100 consented whipple patients as outlined in Johns Hopkins Hospital (JHH)-approved Institutional Review Board (IRB) protocol.
次要结局
- Reduced incidence of delayed gastric emptying in patients with Braun enteroenterostomy(patients will be followed during hospital stay and interviewed at 90 days +/- 2 weeks post surgery)