Practical Application of Indocyanine Green Camera in Laparoscopic Liver Surgery
CAMVIC
2 other identifiers
interventional
120
1 country
1
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."
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2018
CompletedFirst Posted
Study publicly available on registry
July 6, 2018
CompletedStudy Start
First participant enrolled
March 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedApril 17, 2019
April 1, 2019
2 years
May 25, 2018
April 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
bilirubin and prothrombin levels
at Day 1, day 3 and day 5 visits
Study Arms (1)
exploration of abdominal cavity using a NIR/ICG camera
EXPERIMENTALInterventions
exploration of abdominal cavity and liver using a NIR/ICG camera
Eligibility Criteria
You may qualify if:
- men and woman aged of 18 yo and more
- patients with liver tumor
- patient affiliated to french social security
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assistance Publique - Hôpitaux de Parislead
- FLUOPTICScollaborator
Study Sites (1)
Centre Hépato Biliaire de l'hopital Paul Brousse
Villejuif, 94800, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2018
First Posted
July 6, 2018
Study Start
March 18, 2019
Primary Completion
March 1, 2021
Study Completion
October 1, 2021
Last Updated
April 17, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share