The Value of Contrast Enhanced Laparoscopic Ultrasound Examination During Robot-assisted Surgery for Primary Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 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
- 是
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
研究组 & 干预措施
CE-LUS
Laparoscopic ultrasound examination (LUS) of the liver during robot assisted CRC surgery. The liver is systematically scanned for unrecognized liver metastases.
After the laparoscopic LUS procedure, the liver is then systematically scanned with contrast enhancement with SonoVue® containing Sulphurhexafluoride. A bolus of 2.5 ml is injected into a peripheral vein followed by 10 ml of isotonic saline. The liver is then systematically scanned in 3 phases (arterial, venous and parenchymatous phase) searching for unrecognized liver metastases. The procedure is repeated after 5 minutes.
The time it takes to do the scan is measured and any technical challenges are reported. Time, challenges and findings of liver metastases (number, segment and size) are entered on a registration form.
干预措施: CE-LUS (Procedure)
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
MD Signe Bremholm Ellebaek
MD
Odense University Hospital