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临床试验/NCT03895723
NCT03895723Unknown不适用

Minimally Invasive(Laparoscopic and Robotic) Versus Open Liver Resection for Patients With Colorectal Cancer Liver Metastases

Xu jianmin1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2019年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
220
试验地点
1
主要终点
disease-free survival (DFS)

研究概览

简要总结

To examine survival of patients who underwent minimally invasive versus open liver resection for colorectal cancer with liver metastases.

详细描述

the minimally invasive procedure contain laparoscopic or robotic surgery

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 (Outcomes Assessor)

盲法说明

The assessor was masking for patients treatment arms

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

入选标准

  • patients were diagnosed with colorectal cancer liver metastases
  • without extra-hepatic liver metastases
  • age were within 18-75 yeas
  • the numbers of metastases more than 3
  • the maximal tumor size of liver metastases more than 10 cm

排除标准

  • liver metastases were unresectable.

研究组 & 干预措施

Minimally Invasive surgery

Experimental

the intevention of Minimally Invasive procedure contains laparoscopic and robotic liver resection

干预措施: laparoscopic and robotic liver resection (Procedure)

Open surgery

Other

the open surgery means traditional open surgery for liver resection

干预措施: open surgery (Procedure)

结局指标

主要结局

disease-free survival (DFS)

时间窗: 3 years disease-free survival

DFS was calculated from the date of liver resection to the date of death or recurrence or new tumors developing

次要结局

  • Overall survival (OS)(5 years overall survival)
  • Sugical complications(1 months after sugery)

研究者

发起方
Xu jianmin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xu jianmin

Director of colorectal cancer center

Fudan University

研究点 (1)

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