The Effect of Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy in Patients With Different Pancreatic Fistula Risk Scores
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Post-operative Pancreatic Fistula (POPF)
研究概览
简要总结
As one of the possible strategies to prevent pancreatic fistula, peritoneal lavage is still widely used in clinical practice, but it lacks more evidence of evidence-based medicine and recommendations of guidelines. Some clinicians believe that routine flushing after pancreatoduodenectomy wastes medical resources and has a negative impact on patients' comfort.
In this study, the investigators designed a multicenter prospective controlled trial to compare the effects of peritoneal lavage and natural drainage on the incidence of pancreatic fistula and related complications after pancreatoduodenectomy. To study the indications of peritoneal lavage.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperative diagnosis was pancreatic head, lower common bile duct, ampulla and duodenum tumors;
- •Patients with resectable tumors evaluated by imaging examination, and patients who plan to undergo pancreatoduodenectomy;
- •Subjects informed consent, understood and were willing to cooperate with the trial protocol, and signed relevant documents.
排除标准
- •Complicated with severe liver, kidney, heart, brain, lung and other organ complications;
- •Intraoperative changes in surgical methods, such as patients with tumor dissemination and only abdominal opening and closing; Or it needs to be resected in combination with other organs;
- •Patients and their families do not understand the treatment implementation plan of this study;
- •Failure to complete follow-up;
结局指标
主要结局
Post-operative Pancreatic Fistula (POPF)
时间窗: 30 days post-operative
Presence of Amylase \> 3 times the upper limit of normal in surgical drains
次要结局
- Wound infection(90 days post-operative)
- Post-Pancreatectomy Hemorrhage(90 days post-operative)
- Gastrojejunal/Duodenojejunal fistula(90 days post-operative)
- Reoperation(90 days post-operative)
- Biliary fistula(90 days post-operative)
- Mortality(90 days post-operative)
- Delayed Gastric Emptying(90 days post-operative)
- Abdominal abscess or infection(90 days post-operative)
- drainage tube duration(90 days post-operative)
- Length of Hospital Stay(1 year post-operative)
- Readmission(30 days post-operative)