Liver Tumor
Conditions
Keywords
hepatic tumor, liver, ICG, ICG camera, laparoscopy
Brief summary
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.
Detailed description
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.
Interventions
DEVICEexploration of abdominal cavity and liver using a NIR/ICG camera
exploration of abdominal cavity and liver using a NIR/ICG camera
Sponsors
FLUOPTICS
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* men and woman aged of 18 yo and more * patients with liver tumor * patient affiliated to french social security
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| Histological analysis of explanted liver parts | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bilirubin and prothrombin levels | at Day 1, day 3 and day 5 visits | predictive value of the fluorescence dynamic on postoperative hepatic function will be assessed with bilirubin and prothrombin levels at day 1, day 3 and day 5 visits |
Countries
France
Contacts
Primary ContactEric Vibert, PhD
Backup ContactMarc-Antoine Allard
Outcome results
None listed