A Randomized Controlled Study on the Safety of Total Laparoscopy and Traditional Open Pancreaticoduodenectomy in the Treatment of Periampullary Tumors
试验速览
- 阶段
- 不适用
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Incidence of complications
研究概览
简要总结
Pancreaticoduodenectomy (PD) is considered one of the most complex and dangerous procedures in general surgery. This procedure is the preferred surgical procedure for treating tumors around the ampulla. Traditional open pancreaticoduodenectomy (OPD) has brought great surgical trauma to patients while treating diseases. In 1994, Gagner et al first reported laparoscopic pancreaticoduodenectomy (LPD). With the development of laparoscopic techniques, the updating of devices, and the continuous accumulation of laparoscopic gastrointestinal surgery experience, the results of retrospective studies published show that there is no significant difference in safety between LPD and OPD. However, the results of the recently published RCT study show that the mortality associated with LPD complications is five times greater than that of OPD. At present, the security of LPD has been controversial. Therefore we conducted a prospective randomized controlled trial with a primary outcome of perioperative complications, providing evidence-based results for the safe and effective clinical development of LPD.
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
- 20 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
OPD
In this group, patients will undergo open pancreaticoduodenectomy.
干预措施: Open pancreaticoduodenectomy (Procedure)
LPD
In this group, patients will undergo laparoscopic pancreaticoduodenectomy.
干预措施: laparoscopic pancreaticoduodenectomy (Procedure)
结局指标
主要结局
Incidence of complications
时间窗: 30 days after operation
The patients number with complications / The total number in this group
次要结局
未报告次要终点
研究者
Zhongtao Zhang
Chief Physician
Beijing Friendship Hospital
