Prospective Cohort Study Comparing Robotic and Open Surgery for Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 3 years overall survival rate
研究概览
简要总结
The purpose of this study is to determine whether robotic surgery has limitations in terms of patient age, tumor size, location, and vascular relationship when compared to open surgery for pancreatic cancer. Whether robotic surgery has advantages over intraoperative bleeding, operative time, postoperative complications (bleeding, infection, pancreatic fistula) and postoperative hospital stays compared to open surgery.And the differences in lymph nodes harvest and postoperative survival between two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed pancreatic ductal adenocarcinoma
- •Patients and their families volunteered to test and signed informed consent.
排除标准
- •Preoperative exclusion:
- •Patients with metastasis (M1)
- •Patients with tumor recurrence
- •Patients with artery and/or vein invasion and can't perform radical resection and reconstruction
- •Patients with poor cardiopulmonary function cannot tolerate surgery;
- •receive neoadjuvant radiotherapy and chemotherapy before surgery;
- •The patient or family member refuses to join the group;
- •Pregnant patients
- •Intraoperative exclusion:
- •Intraoperative exploration of metastases in other parts besides the primary lesion
- •Other organs malignant tumors metastasize to the pancreas
- •Postoperative exclusion:
- •pathology confirmed non-pancreatic ductal adenocarcinoma
研究组 & 干预措施
robotic pancreatectomy
robotic pancreatectomy(including pancreaticoduodenectomy and distal pancreatectomy)
干预措施: robotic surgery (Procedure)
open surgery
open pancreatectomy(including pancreaticoduodenectomy and distal pancreatectomy)
干预措施: open surgery (Procedure)
结局指标
主要结局
3 years overall survival rate
时间窗: 3 years post-operation
1 year overall survival rate
时间窗: 1 year post-operation
次要结局
- 1, 3years disease free survival rate(1,3years post-operation)
- Postoperative Complications(Within 90 days or before discharge)
研究者
Kai Qin
Principal Investigator
Ruijin Hospital