NCT05755594尚未招募不适用
A Prospective Study on the Safety and Efficacy of Robot-assisted Pancreaticoduodenectomy
The First Affiliated Hospital of University of South China0 个研究点目标入组 100 人开始时间: 2023年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Rate of long-term Survival
研究概览
简要总结
Further studies are needed to investigate the prognosis and perioperative safety of patients undergoing robotic-assisted pancreaticoduodenectomy. In this study, clinical data and prognostic data of patients undergoing this procedure were prospectively collected and analyzed to explore its safety and efficacy.
详细描述
Perioperative clinical data and prognostic data of patients undergoing robotic-assisted pancreaticoduodenectomy were collected and analyzed to explore the safety and efficacy of this surgical approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The way of surgery.
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
- •Over 18 years old
- •Preoperative imaging suggested the presence of space occupying in the head of the pancreas, ampullary abdomen, and distal common bile duct tumor lesions to be treated with Pancreaticoduodenectomy
- •No distant transfer
- •No significant vascular invasion was received
排除标准
- •With tumors of other organs
- •Patients unable to tolerate anesthesia and operation due to serious abnormalities in functions of heart, lung and other important organs
- •Patients found intraoperative peripheral organ metastasis combined with excision of other organs or found intraoperative radical excision could not be performed and underwent palliative drainage surgery or end the surgery
- •Preoperative adjuvant therapy was given
结局指标
主要结局
Rate of long-term Survival
时间窗: 3 years
survival will be documented 3 years after surgery
次要结局
- Unplanned re-admission rate after discharge within 30 days(3 months)
- Incidence of postoperative complications(2 months)
研究者
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