跳至主要内容
临床试验/NCT04037982
NCT04037982Unknown不适用

A Randomized Controlled Study on the Safety of Total Laparoscopy and Traditional Open Pancreaticoduodenectomy in the Treatment of Periampullary Tumors

Beijing Friendship Hospital1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2019年8月最近更新:
适应症
干预措施

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

OPD

Active Comparator

In this group, patients will undergo open pancreaticoduodenectomy.

干预措施: Open pancreaticoduodenectomy (Procedure)

LPD

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhongtao Zhang

Chief Physician

Beijing Friendship Hospital

研究点 (1)

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