Technical Strategies for Pancreatic Fistula Prevention After Pancreaticoduodenectomy in High-risk Pancreatic Remnant: a Risk-adjusted Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Post-operative Pancreatic Fistula (POPF)
研究概览
简要总结
This trial will investigate what surgical technique between pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains is associated with the lowest rate of pancreatic fistula after pancreaticoduodenectomy in case of high-risk pancreatic remnants.
详细描述
Pancreatic fistula is the major determinant of outcome after pancreaticoduodenectomy. Several strategies to reduce the burden of this complication have been proposed in the last decade. A definite answer about what is the best technique to approach a high-risk pancreatic stump is still needed. Both pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains have been proposed in this setting, but often studies do not provide a reliable risk stratification and result are extremely variable.
The aim of this trial is to evaluate what surgical technique, between pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains, is associated with the lowest rate of pancreatic fistula in case of high-risk pancreatic remnants. Risk stratification will be provided through the Fistula Risk Score, a clinical risk score that has been extensively validated.
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, Care Provider)
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
- •All the patients undergoing pancreaticoduodenectomy (only Whipple or Traverso) for all kind of pancreatic disease (benign, malignant or premalignant).
- •Patients able to give their informed consent
- •Exclusion criteria
- •Informed consent withdrawal
- •Impossibility to undergo surgery for any reason
- •Use of glues or biological matrices to protect the anastomosis
- •Fistula Risk Score < 7
- •Post-operative octreotide analogues administration (only prophylactic use, therapeutic use allowed)
- •Wrong randomization
排除标准
- 未提供
研究组 & 干预措施
Pancreaticogastrostomy
Pancreaticogastrostomy with external drain
干预措施: Pancreaticogastrostomy with external drain (Procedure)
Pancreaticojejunostomy
Pancreaticojejunostomy with transanastomotic drain
干预措施: Pancreaticojejunostomy with transanastomotic drain (Procedure)
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 at or by post-operative day 3 (POD) determining a clinically relevant change in patient's management
次要结局
- Respiratory insufficiency(90 days)
- Urinary Tract Infection(90 days)
- Cerebrovascular accidents(90 days)
- Delayed Gastric Emptying(90 days)
- Wound infection(90 days)
- Blood transfusions(90 days)
- Pneumonia(90 days)
- Post-Pancreatectomy Hemorrhage(90 days)
- Myocardial infarction(90 days)
- Acute Kidney Failure(90 days)
- Biliary fistula(90 days)
- POPF severity(30 days post-operative)
- Length of Hospital Stay(1 year)
- Mortality(90 days)
- Gastrojejunal/Duodenojejunal fistula(90 days)
- Acute pancreatitis(1 day post index surgery)
- Reoperation(90 days)
- Readmission(30 days after hospital discharge)
- Abdominal abscess(90 days)
- Pulmonary Embolism(90 days)
- Time-to-adjuvant therapy(1 year)