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临床试验/NCT02457390
NCT02457390已完成不适用

The Value of Contrast Enhanced Laparoscopic Ultrasound Examination During Robot-assisted Surgery for Primary Colorectal Cancer

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Detection of synchronous liver metastases with CE-LUS

研究概览

简要总结

Laparoscopic ultrasound examination performed during surgery for primary cancer of the colon and rectum (CRC) has been shown to be able to detect liver metastasis that are not recognized by conventional computer tomography (CT scan) prior to surgery.

Today most of the colorectal cancer resections are performed by laparoscopy, but robotic technology is gradually developed in an attempt to overcome some of the limitations characterized by laparoscopy. The use of contrast enhanced laparoscopic ultrasound examination (CE-LUS) of the liver during robot-assisted CRC surgery has not been studied, and this despite the fact that it seems technically possible to perform.

With this project we will investigate whether CE-LUS associated with robotic surgery for CRC is technically feasible and whether it will be able to detect synchronous liver metastases that have not been detected on the preoperative imaging modalities.

详细描述

Title:

The value of contrast enhanced laparoscopic ultrasound examination during robot-assisted resection for primary colorectal cancer surgery.

Project:

The following project evaluates the value of contrast enhanced Laparoscopic Ultrasound examination (CE-LUS) in robot-assisted surgery for CRC.

The project "The value of contrast enhanced laparoscopic ultrasound examination during robot-assisted resection for primary colorectal cancer surgery" is a part of a Ph.D study at the University of Southern Denmark.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients scheduled to robot-assisted CRC resection
  • patients with histologically verified cancer i colon or rectum
  • informed consent
  • patients with minimum age of 18
  • patients without liver metastases

排除标准

  • patients who have not given informed consent
  • patients with severe heart disease, lung hypertension, or had had a heart attack < 7 days
  • patients with alcohol or drug abuse.
  • patients with liver metastases

结局指标

主要结局

Detection of synchronous liver metastases with CE-LUS

时间窗: 3 months

次要结局

  • CE-LUS feasibility(15 minuts)

研究者

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

MD Signe Bremholm Ellebaek

MD

Odense University Hospital

研究点 (2)

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