Clinical trial NCT03579199: Practical Application of Indocyanine Green Camera in Laparoscopic Liver Surgery
Official title: Practical Application of Indocyanine Green Camera in Laparoscopic Liver Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Tumor
Keywords: hepatic tumor
liver
ICG
ICG camera
laparoscopy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: FLUOPTICS
First posted: 2018-07-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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."

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: through study completion, an average of 6 months
measure: Histological analysis of explanted liver parts
timeFrame: 1 month
Secondary outcomes:
measure: bilirubin and prothrombin levels
timeFrame: at Day 1, day 3 and day 5 visits
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Centre Hépato Biliaire de l'hopital Paul Brousse
Study officials:
References: