Billroth II or Roux-en-Y Reconstruction for Gastrojejunostomy After Pancreaticoduodenectomy: Randomized Controlled Trial (PAUDA TRIAL): Comparison of Morbidity and Delayed Gastric Emptying
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Delayed gastric emptying incidence after pancreaticoduodenectomy
研究概览
简要总结
The aim of the study is to compare the effect of Roux-en Y reconstruction (study group, DPCDA) versus classical Child reconstruction (DPCUN) in the incidence of VGL in patients for DPC. The hypotesis of the study is that Roux-en Y reconstruction decreases incidence of DGE after pancreaticoduodenectomy.
详细描述
The pancreaticoduodenectomy (DPC) is the procedure of choice of the tumors of the head of the pancreas, periampullary tumors and intractable inflammatory pathology.
The high postoperative morbidity (50%) involve a mean hospital stay of 15 days after surgery. The most common complication is delayed gastric emptying (DGE), defined as the intolerance to solid oral intake by 7th day postoperative. In some severe cases, oral intolerance can occur after the 21th postoperative day. Therefore, the patient requires parenteral nutrition and prolonged hospital stay.
The aim of the study is to compare the effect of Roux-en Y reconstruction (study group, DPCDA) versus classical Child reconstruction (DPCUN) in the incidence of VGL in patients for DPC.
The hypotesis of the study is that Roux-en Y reconstruction decreases incidence of DGE after pancreaticoduodenectomy.
A pilot randomized clinical trial has been designed to compare two surgical techniques for reconstruction of digestive tract after DPC in patients treated in our center. The patients are randomized after tumor resection and before the reconstruction througt computer-generated random numbers using a sealed envelope technique. The primary endpoint is the incidence of DGE. Secondary endpoints are postoperative morbidity and specific complications as pancreatic fistula, the hospital stay, and postoperative endocrine and exocrine function.
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 with pancreatic head cancer considered resectable after the extension study
- •Patients suffering from periampullary tumors considered resectable after the extension study
- •Patients suffering from pancreatic inflammatory disease with medically intractable pain
- •Patients who have read the information sheet of the study and signed the informed consent form
排除标准
- •Patients with history of previous gastrectomy
- •Patients with associated resections of other organs, except for the superior portal vein or mesenteric vein
- •Patients with enlargement to total pancreatectomy
- •Patients who has recieved neoadjuvant treatment
- •Patients with plastic peritonitis
- •Patients with liver cirrhosis.
研究组 & 干预措施
DPC UN
Child reconstruction after pancreaticoduodenectomy
干预措施: Pancreaticoduodenectomy (Procedure)
DPC DN
Roux-en Y reconstruction after pancreaticoduodenectomy
干预措施: Pancreaticoduodenectomy (Procedure)
结局指标
主要结局
Delayed gastric emptying incidence after pancreaticoduodenectomy
时间窗: within the first 60 daysafter surgery
DGE, defined as oral diet intolerance from the 7th postoperative day, and the persistence of nasogastric tube on the 4th postoperative day or later, according to the ISGPS criteria
次要结局
- Morbidity and complications after pancreaticoduodenectomy(within the first 60 daysafter surgery)
研究者
JULI BUSQUETS BARENYS
Medicine Doctor
Hospital Universitari de Bellvitge