- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03579199
Practical Application of Indocyanine Green Camera in Laparoscopic Liver Surgery (CAMVIC)
"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."
Study Overview
Status
Conditions
Intervention / 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."
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eric Vibert, PhD
- Phone Number: +33 1 45 59 30 36
- Email: eric.vibert@aphp.fr
Study Contact Backup
- Name: Marc-Antoine Allard
- Email: marcantoine.allard@aphp.fr
Study Locations
-
-
-
Villejuif, France, 94800
- Recruiting
- Centre Hépato Biliaire de l'hopital Paul Brousse
-
Contact:
- Eric Vibert, PhD
- Phone Number: +33 1 45 59 30 36
- Email: eric.vibert@aphp.fr
-
Contact:
- Marc Antoine ALLARD
- Email: marcantoine.allard@aphp.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional 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
|
exploration of abdominal cavity and liver using a NIR/ICG camera
|
What is the study measuring?
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
Time Frame: 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
|
through study completion, an average of 6 months
|
Histological analysis of explanted liver parts
Time Frame: 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
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
bilirubin and prothrombin levels
Time Frame: 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
|
at Day 1, day 3 and day 5 visits
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P170105J
- 2017-A02807-46 (Other Identifier: N° IDRCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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