Intraoperative Biodegradable Stent Placement to Reduce Complications After Pancreatoduodenectomy - Protocol and Statistical Analysis Plan for Randomized, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- POPF
研究概览
简要总结
The aim of this prospective, randomized, blinded clinical superiority trial is to establish intraoperative placement of biodegradable stents in the pancreatojejunostomy as a safe, effective, and feasible preventive measure against pancreatic fistula following pancreatoduodenectomy.
The investigators hypothesize that intraoperative placement of biodegradable stents in the pancreatojejunostomy is safe and can reduce the risk of pancreatic leakage following pancreatoduodenectomy in patients who have not undergone PBD.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The investigators will mask the allocation for the outcome assessors and trial statistician who will conduct the analyses, and the author group while writing the abstract for the trial report with the two intervention groups coded as 0 and 1. Due to the nature of the intervention and control, the trial will not be blinded for the surgeons performing the interventions
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 a pancreatoduodenectomy
- •Patients aged 18 or above
- •Patients who have given an informed consent
排除标准
- •Patients who do not or cannot give an informed consent.
- •Patients with at a high risk or with previous history of multiple thrombo-embolic diseases or bleeding disorders.
- •Patients undergoing active immunosuppressive therapy.
结局指标
主要结局
POPF
时间窗: 30 days
Number of participants with a Postoperative pancreatic fistula
Number of participants with a Biliary fistula
时间窗: 30 days
Postoperative biliary fistula
次要结局
- Mortality(30 days and 90 days)
- LOS(Length in days, from surgery until discharge ( up to 200 days from surgery))
- Complications to stent placement(30 days)
- Postoperative complications(30 days postoperative)
- Quality of Life according to VR12 Quality of Life Score(30 days post surgery)
研究者
Waqas Farooqui
Generel Surgeon
Rigshospitalet, Denmark