A Randomized Prospective Multicenter Trial of Early Versus Late Drain Removal After Pancreaticoduodenectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 319
- 试验地点
- 2
- 主要终点
- The sum of grade 2- 4 complications
研究概览
简要总结
The aim of this randomized prospective multicenter study is to demonstrate the hypothesis that early removal of drain could reduce the incidence of major complications (grade 2-4) after pancreaticoduodenectomy (PD) , when compared with later removal of drain.
详细描述
The objective of this randomized prospective multicenter study is to investigate the association between the time of removal of drain after pancreaticoduodenectomy (PD) and incidence of major complications (grade 2-4 complications). The investigators unite six pancreatic surgery center in Beijing. Patients who underwent pancreaticoduodenectomy (PD) or pylorus-preserving pancreaticoduodenectomy (PPPD) with low to moderate risk of post-operative pancreatic fistula (POPF) are recruited into the study. After obtaining informed consent, eligible patients are randomly allocated to early or late drain removal group on POD 3. In the group A, drain(s) are removed on POD 3, whereas in group B drain is removed on POD 5 or beyond. The primary outcomes are the incidence of sum of grade 2-4 complications, the secondary outcomes include grade B/C POPF, intra-abdominal infeciton, delayed gastric emptying, post-operative bleeding, in-hospital stay, total medical cost and comprehensive complication index (CCI).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PD with or without pylorus preserving;
- •Age between 18 and 75 years;
- •Drain amylase on POD 1 and 3 less than 5000 U/L;
- •Drain output within POD 3 less than 300 ml per day.
排除标准
- •Vascular reconstruction using an artificial graft;
- •Grade B/ C postoperative bleeding, evident anastomosis leakage within 3 days after surgery;
- •Refusale to participate in after signed informed consent.
结局指标
主要结局
The sum of grade 2- 4 complications
时间窗: Up to postoperative 90 days
The severity of complication was measured by Clavein Dindo classifications and grade 2- 4 complications always affect the recovery of the patients significantly.However, the death case (grade 5 complication) is rare now for PD in high volume centers. According to our single center study, early drain removal could reduce the rate of grade 2-4 complications by 12% for the patients undergoing major pancreatectomy.
次要结局
- Intra-abdominal bleeding(Up to postoperative 90 days)
- Comprehensive complication index (CCI)(Up to postoperative 90 days)
- Total medical expenses(Up to postoperative 90 days)
- Length of hospital stay (day)(Up to postoperative 90 days)
- Delayed gastric emptying(Up to postoperative 90 days)
- Grade B/C complications(Up to postoperative 90 days)
- Any other single intem of grade 2-4 complication(Up to postoperative 90 days)
- Interventional treatment(Up to postoperative 90 days)