Impact of Braun Anastomosis on Reduction in Delayed Gastric Emptying Following Pancreaticoduodenectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Comparison of Delayed gastric emptying syndrome occurrence
研究概览
简要总结
Pylorus preserving pancreaticoduodenectomy (PPPD) has been considered as only curative treatment modality for periampullary tumor. High mortality rates after PPPD have been reduced down to 1%. However, postoperative morbidities are still reported around 10 to 20 % even in high volume centers.The delayed gastric emptying syndrome(DGE) is one of major complications after PPPD. Many randomized control studies reported that pylorus preserving method was not related to the occurence of DGE. Thus,we assumed that large amount of biliary and pancreatic juice might affect DGE.
With the aim to prove that the use of Braun anastomosis after PPPD can prevent DGE, the investigators started the recruitment of patients with a periampullary tumors to this clinical trial from february 2013 with the study hypothesis that patients with Braun anastomosis had less DGE than those who only got conventional PPPD.
The investigators have calculated the number of patients necessaries to have statistical significant differences in 60 patients with a rate DGE expected to be higher than 30%.
The study include all the patients that usually arrive to our surgery department and who are indicated to PPPD for the curative treatment of periampullary tumor.
The study is randomized, double blind where the investigators and the patients do not know if the patients are in the Braun anastomosis group or not, and prospectively analyzed. All the clinical and laboratory or radiographic finds relative to the occurrence of DGE are recorded.
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
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with periampullary disease who have to be treated by PPPD
- •pancreatic cancer, distal bile duct cancer, duodenal cancer, and so on.
- •20 year to 80 year-old patients
- •In terms of general performance status, the patients with more than 70% of the Karnofsky score or ECOG 0 to 1.
排除标准
- •Patients with unresectable or locally advanced and metastatic cancer.
- •The patient who does not want to take the operation.
- •The patient with more than 3 of ASA score.
- •Drug abusers or alcoholics.
- •Non-compliances
- •The patient who does not want to participate the clinical trials.
- •The patients who can not read or understand about informed consent form such as a mentally retarded person, the blind, illiteracy, or foreigner.
- •The patient who have previous transabdominal surgery
- •The patient who have to have resection of other organs or vessels other than standard PPPD
- •The patient who is indicated to laparoscopic PPPD
研究组 & 干预措施
Braun anastomosis group
干预措施: PPPD with Braun anastomosis (Procedure)
conventional group
conventional Pylorus preserving pancreaticoduodenectomy
干预措施: conventional PPPD (Procedure)
结局指标
主要结局
Comparison of Delayed gastric emptying syndrome occurrence
时间窗: 10 days after operation
Comparison of DGE occurrence between Braun anastomosis group and conventional Pylorus preserving pancreaticoduodenectomy without Braun anastomosis group
次要结局
未报告次要终点