Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice: A Phase III, Randomized, Controlled, Single Center Study.
试验速览
- 阶段
- 3 期
- 入组人数
- 136
- 主要终点
- the difference in postoperative morbidity
研究概览
简要总结
Patients with the lower malignant obstructive jaundice planned to do the pancreaticoduodenectomy, receiving preoperative biliary drainage or early surgery (without preoperative biliary drainage), both groups has the similar surgical morbidity, no statistics significance.
详细描述
Patients with the lower malignant obstructive jaundice divided into two groups:early surgery, preoperative biliary drainage + surgery.
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
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with the lower malignant obstructive jaundice
- •Total bilirubin: 150-350 umol/L
排除标准
- •age less than 18
- •emergency operation
- •biliary tract stent placed
- •past history of operation on pancreas
- •intraoperative unresectable tumor with pancreaticoduodenectomy
- •unresectable tumor or potential resectable tumor with pancreaticoduodenectomy
研究组 & 干预措施
early surgery
only receiving pancreaticoduodenectomy without preoperative biliary drainage
preoperative biliary drainage
percutaneous preoperative biliary drainage before pancreaticoduodenectomy guided by CT scan
干预措施: preoperative biliary drainage (Procedure)
结局指标
主要结局
the difference in postoperative morbidity
时间窗: 12 weeks postoperation
the difference in postoperative morbidity between two groups (preoperative biliary drainage or early surgery (without preoperative biliary drainage))
次要结局
未报告次要终点