Extended Retroperitoneal Lymphadenectomy and Nerve Plexus Clearance Versus Standard Lymphadenectomy in Pancreaticoduodenectomy for Adenocarcinoma of the Pancreatic Head in a Chinese Population:A Multicenter, Open-label, Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This clinical trial is about the survival benefit of extended lymphadenectomy and nerve clearance versus standard lymphadenectomy in pancreaticoduodenectomy of pancreatic adenocarcinoma，which is a multicenter，prospective，ramdomized clinical trials.
详细描述
The purpose of this clinical trial is for assessing the survival benefit of extended lymphadenectomy and nerve clearance versus standard lymphadenectomy in pancreaticoduodenectomy of pancreatic adenocarcinoma. And we will focus on the R0 resection using LEEPP(Leeds Pathology Protocol) methods to check whether the tumor is eradicated or not.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-70 years; Karnofsky performance>70; preoperative diagnosis as resectable pancreatic head cancer; patients' relative have signed consent form.
排除标准
- •also have severe cardiopulmonary disease, autoimmune disease, chronic renal failure disease; recurrent pancreatic tumor or unresectable tumor; benign pancreatic tumor; also have other malignant tumors.
结局指标
主要结局
Overall survival
时间窗: From date of randomization until the date of death from any cause, assessed up to 100 months
The overall survival of the patients from the time of surgery until the date of pass-away.
次要结局
- Disease free survival(From date of randomization until the date of first documented progression( local recurrence or metastasis), assessed up to 100 months.)