Practical Application of Indocyanine Green Camera in Laparoscopic Liver Surgery (CAMVIC)
Primary Purpose
Liver Tumor
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
exploration of abdominal cavity and liver using a NIR/ICG camera
Sponsored by
About this trial
This is an interventional diagnostic trial for Liver Tumor focused on measuring hepatic tumor, liver, ICG, ICG camera, laparoscopy
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
Sites / Locations
- Centre Hépato Biliaire de l'hopital Paul BrousseRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
exploration of abdominal cavity using a NIR/ICG camera
Arm Description
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03579199
First Posted
May 25, 2018
Last Updated
April 16, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
FLUOPTICS
1. Study Identification
Unique Protocol Identification Number
NCT03579199
Brief Title
Practical Application of Indocyanine Green Camera in Laparoscopic Liver Surgery
Acronym
CAMVIC
Official Title
Practical Application of Indocyanine Green Camera in Laparoscopic Liver Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
FLUOPTICS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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."
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Tumor
Keywords
hepatic tumor, liver, ICG, ICG camera, laparoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
exploration of abdominal cavity using a NIR/ICG camera
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
exploration of abdominal cavity and liver using a NIR/ICG camera
Intervention Description
exploration of abdominal cavity and liver using a NIR/ICG camera
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
through study completion, an average of 6 months
Title
Histological analysis of explanted liver parts
Description
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
Time Frame
1 month
Secondary Outcome Measure Information:
Title
bilirubin and prothrombin levels
Description
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
Time Frame
at Day 1, day 3 and day 5 visits
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Vibert, PhD
Phone
1 45 59 30 36
Ext
+33
Email
eric.vibert@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marc-Antoine Allard
Email
marcantoine.allard@aphp.fr
Facility Information:
Facility Name
Centre Hépato Biliaire de l'hopital Paul Brousse
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Vibert, PhD
Phone
1 45 59 30 36
Ext
+33
Email
eric.vibert@aphp.fr
First Name & Middle Initial & Last Name & Degree
Marc Antoine ALLARD
Email
marcantoine.allard@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Practical Application of Indocyanine Green Camera in Laparoscopic Liver Surgery
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