Practical Application of Indocyanine Green Camera in Laparoscopic Liver Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Histological analysis of explanted liver parts
研究概览
简要总结
"Indocyanine Green (ICG) is a dye used as an indicator of hepatic function considering its capacity to be eliminated only by the bile. Thus, ICG tend to remain in liver tumors.
The hypothesis of CAMVIC study is that the use of fluorescence imaging during laparoscopic hepatic surgery will allow to detect small subcapsular superficial lesions undetected by other diagnostic methods, which will improve the results of the oncologic treatment."
详细描述
"Thanks to the property of ICG to release a fluorescent signal when excited by a Near Infra Red (NIR) light source, ICG fluorescence has been widely used during several clinical situations (angiography, lymphography,..). Few years ago it has been shown that hepatic tumors could be seen with a NIR camera able to view ICG fluorescence thanks to the depot in or around the tumor of the dye injected during preop.Since, this fluorescence imaging technique potential has been underlined to identify tumors undiagnosed before surgery. Pre-operative examination of hepatic lesions is based on 3 points:
- visual examination
- two-hand palpation
- intra-operative ultrasound.
During laparoscopic hepatic surgery it is not possible to palpate the liver thus peroperative examination of the liver surface is harder than during open surgery. Moreover per-operative ultrasound is not a reliable tool in order to explore liver surface. However the latest development of NIR cameras able to view ICG fluorescence could add a benefit in laparoscopic surgery in view of its capacity to detect superficial lesions, even those of small dimension."
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
- 否
入选标准
- •men and woman aged of 18 yo and more
- •patients with liver tumor
- •patient affiliated to french social security
排除标准
- •Patient unable to give a signed informed consent
- •patient under guardianship or curator
- •patient deprived of liberty by judicial or administrative decision or placed under judicial protection
- •patient refusing to undergo the specific technique
- •pregnant or lactating women
- •patient with icteric cholestasis
- •patient with contraindication to coelioscopy
- •patient with known allergy to cyanines
- •patient who must undergo staged hepatectomy
结局指标
主要结局
Histological analysis of explanted liver parts
时间窗: 1 month
histological analysis will indicate the nature of the explanted part: tumoral tissue or healthy tissues. Results will be obtained during the month following the hepatectomy
number of superficial nodules detected with the device during peroperative examination compared to the number of superficial nodules detected during preoperative imaging and new surface nodules detected at 6 month postoperative imaging
时间窗: through study completion, an average of 6 months
sensitivity will be assessed by the number of superficial nodules detected with the device during peroperative examination compared to the number of superficial nodules detected during preoperative imaging and new surface nodules detected at 6 month postoperative imaging
次要结局
- bilirubin and prothrombin levels(at Day 1, day 3 and day 5 visits)