Practical Application of Indocyanine Green Camera in Laparoscopic Liver Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Practical Application of Indocyanine Green Camera in Laparoscopic Liver Surgery

Conditions
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Liver Tumor

Intervention / Treatment
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* Device: exploration of abdominal cavity and liver using a NIR/ICG camera


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exploration of abdominal cavity using a NIR/ICG camera<br> | Device: exploration of abdominal cavity and liver using a NIR/ICG camera<br>* exploration of abdominal cavity and liver using a NIR/ICG camera<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | through study completion, an average of 6 months | 
| Histological analysis of explanted liver parts | 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 | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bilirubin and prothrombin levels | 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 | at Day 1, day 3 and day 5 visits | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICG, hepatic tumor, liver, ICG camera, laparoscopy