Liver TumorCAMVICNCT03579199
Practical Application of Indocyanine Green Camera in Laparoscopic Liver Surgery
A study testing exploration of abdominal cavity and liver using a NIR/ICG camera in people with Liver Tumor, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Tumor
- What is being tested?
- exploration of abdominal cavity and liver using a NIR/ICG camera
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 18 Mar 2019to Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and woman aged of 18 yo and more
- patients with liver tumor
- patient affiliated to french social security
Who cannot join
- 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
Show all 9Show fewer
- patient with contraindication to coelioscopy
- patient with known allergy to cyanines
- patient who must undergo staged hepatectomy
Trial locations and contacts
1 site in 1 country.
Marc-Antoine Allard contact
France1 site, 1 recruiting
- Recruiting
Centre Hépato Biliaire de l'hopital Paul Brousse
Villejuif, 94800
Eric Vibert, PhD, 1 45 59 30 36 ext. +33, eric.vibert@aphp.fr
Marc Antoine ALLARD, marcantoine.allard@aphp.fr
About this study
"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."
Read the 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."
- Conditions
- Liver Tumor
- Being tested
- exploration of abdominal cavity and liver using a NIR/ICG camera
- Keywords
- hepatic tumor, liver, ICG, ICG camera, laparoscopy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exploration of abdominal cavity and liver using a NIR/ICG cameraDevice
exploration of abdominal cavity and liver using a NIR/ICG camera
| Study group | Role | What they receive |
|---|---|---|
| exploration of abdominal cavity using a NIR/ICG camera | Experimental | Not described Receives: Device: exploration of abdominal cavity and liver using a NIR/ICG camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 month
Secondary outcomes (1)
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
Measured: at Day 1, day 3 and day 5 visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start18 Mar 2019
- Primary completionMar 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TumorStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- FLUOPTICS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579199
- Sponsor's protocol ID
- P170105J
- Other IDs
- 2017-A02807-46
- Acronym
- CAMVIC
- Status last verified
- Apr 2019
- First submitted
- 25 May 2018
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practical Application of Indocyanine Green Camera in Laparoscopic Liver Surgery
- ClinicalTrials.gov ID
- NCT03579199
- Acronym / sponsor ID
- CAMVIC / P170105J
- Conditions
- Liver Tumor
- Keywords
- hepatic tumor, liver, ICG, ICG camera, laparoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- FLUOPTICS
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 6 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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."
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exploration of abdominal cavity using a NIR/ICG camera | Experimental | Device: exploration of abdominal cavity and liver using a NIR/ICG camera |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men and woman aged of 18 yo and more
- patients with liver tumor
- patient affiliated to french social security
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exploration of abdominal cavity and liver using a NIR/ICG cameraexploration of abdominal cavity and liver using a NIR/ICG camera | Device | exploration of abdominal cavity using a NIR/ICG camera |
Primary outcome
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
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 secondary outcome
bilirubin and prothrombin levels
Time frame: at Day 1, day 3 and day 5 visits
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc-Antoine Allard contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exploration of abdominal cavity and liver using a NIR/ICG camera in people with Liver Tumor, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric Vibert, PhD (1 45 59 30 36 ext. +33, eric.vibert@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.