Clinical Randomized Trial Investigating a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy in Patients With a High Risk for Postoperative Pancreatic Fistula
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 4
- 主要终点
- Clinically Relevant Postoperative Pancreatic Fistula
研究概览
简要总结
Pancreaticoduodenectomy is a surgical procedure for removing cancer in the pancreas, the bile system or the duodenum that is associated with a high rate of complications. The study wants to investigate whether a new technique to reconstruct the joint between the pancreatic gland and the short bowel can reduce the rate of severe complications after this complex surgical procedure.
详细描述
Pancreaticoduodenectomy is a complex surgical procedure for radically resecting tumors in the pancreatic head, distal bile duct or duodenum. Postoperative pancreatic fistula is the main contributor of severe postoperative morbidity after pancreaticoduodenectomy. Characteristics of the pancreatic gland like soft pancreatic consistency and small pancreatic main duct predispose for the postoperative fistula development. In high risk patients, the risk of suffering from associated postoperative morbidity is 50 percent which is considered unacceptable high. The aim of the current trial is to investigate whether a new anastomosing technique for the pancreaticojejunostomy can reduce the incidence of associated postoperative morbidity in patients undergoing pancreaticoduodenectomy.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective pancreaticoduodenectomy
- •Pancreatic gland with high risk criteria for associated postoperative morbidity
排除标准
- •Patients do not accept participation
- •Pancreatic gland with intermediate or low risk criteria for associated postoperative morbidity
研究组 & 干预措施
Conventional anastomosis
Conventional anastomosis: The pancreaticojejunostomy is carried out in a traditional way according to "Cattell's duct-to-mucosa technique".
Novel anastomosis
Novel anastomosis: This the active comparator to the conventional anastomosis. A new pancreaticojejunostomy technique is used for the reconstruction. The pancreas is intubated into the jejunum.
干预措施: Pancreaticojejunostomy technique (Procedure)
结局指标
主要结局
Clinically Relevant Postoperative Pancreatic Fistula
时间窗: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula
次要结局
- Associated postoperative morbidity(participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
研究者
Christoph Ansorge
Christoph Ansorge, MD, PhD
Karolinska Institutet