HepatocarcinomaPERSEENCT03718078
Robotic Endomicroscopy to Better Define Resection Strategies Applied to Hepatic Surgery
A study testing Confocal Laser Endomicroscopy in people with Hepatocarcinoma and Hepatic Metastasis, run by Mauna Kea Technologies at 1 site in France.
Trial summary
This study aims at assessing the feasibility of Probe-based Confocal Laser Endomicroscopy (pCLE) during laparoscopic hepatic masses resection for intra-operative characterisation of hepatic masses and surgical margins assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocarcinoma, Hepatic Metastasis, Hepatic Tumor
- What is being tested?
- Confocal Laser Endomicroscopy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2019to 7 Jan 2020
- 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
- Over 18 years
- Scheduled for a surgical resection of hepatic masses
- Provided signed informed consent
Who cannot join
- Allergy to Indocyanine green (ICG)
- Kidney failure
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Mutualiste Montsouris
Paris, 75014
David Fuks, MD
David Fuks, MD, PhD, Prof
About this study
Official title: Essai Clinique Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d'ExérèsE (PERSÉE) appliquée à la Chirurgie Hépatique
This study aims at assessing the feasibility of Probe-based Confocal Laser Endomicroscopy (pCLE) during laparoscopic hepatic masses resection for intra-operative characterisation of hepatic masses and surgical margins assessment.
Read the detailed description
Colorectal cancer is the third most common cancer and third leading cause of cancer deaths in the Western countries. In France, 45.000 new patients develop colorectal cancer every year. The liver is the most common organ targeted by CRLM, representing 50%. Approximately, 15-25% of colorectal cancer patients have synchronous CRLM at initial workup, and 20-30% patients sustain subsequent liver metastases within few years following diagnosis.
The strategy for colorectal cancer liver metastasis resection and liver cancer has evolved to a parenchymatic sparing procedure. This technic aims to minimize surgical margins width while removing the tumor. Therefore, the current standard for resection margins is a margin width superior to 1mm. However, there is still a debate concerning the margin width. Indeed, with modern chemotherapy, several studies reported no statistical differences in the overall survival between R0 patients and R1 patients treated with chemotherapy. However, in order to preserve patients from chemotherapy treatments' adverse effects an intra-operative microscopic assessment of surgical margins should be set up in order to reduce R1 margins occurrence.
Ex vivo study:
Surgical specimens obtained during hepatectomy will be imaged to generate an atlas of pCLE images.
In vivo study:
Intraoperative characterization of sub-capsular hepatic masses and surgical margins will be assessed.
- Conditions
- Hepatocarcinoma, Hepatic Metastasis, Hepatic Tumor
- Being tested
- Confocal Laser Endomicroscopy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confocal Laser EndomicroscopyDevice
Also called probe-based Confocal Laser Endomicroscopy, CelioFlex UHD 5 probe, Viziobot-P, GastroFlex UHD probe
The study is divided in two parts. For the two parts, patients will receive an intravenous injection of indocyanine green:
- Ex vivo study
- Images/sequences of normal and abnormal hepatic tissues and surgical margins will be acquired on surgical specimens
- In vivo study - Intra-operative pCLE imaging will be performed on hepatic masses and surgical margins
| Study group | Role | What they receive |
|---|---|---|
| Confocal Laser Endomicroscopy | Experimental | lt includes patients will undergo probe-based Confocal Laser Endomicroscopy during laparoscopic hepatic masses resection. Receives: Device: Confocal Laser Endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
malignant pCLE criteria
Definition of pCLE criteria for normal and malignant hepatic tissues
Measured: 1 year
Secondary outcomes (6)
pathological pCLE criteria
Definition of pCLE criteria for pathological hepatic parenchyma (non tumoral)
Measured: 1 year
Ease of use of the endomicroscopy device
The ease of use of the endomicroscopy device will be assessed using a questionnaire that the surgeon will fill at the end of each procedure
Measured: 1 year
Audio/video telecommunication quality
The telecommunication quality will be assessed using a questionnaire that the surgeon and the anatomopathologist will fill at the end of each procedure
Measured: 1 year
Number of participants with CLE imaging-related adverse events as assessed by CTCAE v5.0
The device safety will be measured by assessing the occurence and severity of adverse events during the study
Measured: 1 year
Stability and reproducibility of images/sequences during procedures
The stability and reproducibility of endomicroscopy images will be assessed using a questionnaire that the surgeon and the anatomopathologist will fill at the end of each procedure
Measured: 1 year
pCLE criteria diagnostic performance
The diagnostic performance of identified pCLE criteria will be expressed by their sensitivities, specificities, negative predictive value and positive predictive value.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study startMar 2019 (estimated)
- Primary completion7 Jan 2020 (estimated)
- Study completion7 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatocarcinomaStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mauna Kea Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718078
- Sponsor's protocol ID
- MKT-2018-PERSEE-02-DIG
- Other IDs
- 2018-A02619-46
- Acronym
- PERSEE
- Status last verified
- Jan 2019
- First submitted
- 23 Oct 2018
- Last updated
- 24 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Essai Clinique Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d'ExérèsE (PERSÉE) appliquée à la Chirurgie Hépatique
- ClinicalTrials.gov ID
- NCT03718078
- Acronym / sponsor ID
- PERSEE / MKT-2018-PERSEE-02-DIG
- Conditions
- Hepatocarcinoma, Hepatic Metastasis, Hepatic Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mauna Kea TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Mar 2019 (estimated)
- Primary completion
- 7 Jan 2020 (estimated)
- Study completion
- 7 Jan 2020 (estimated)
- First posted
- 24 Oct 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.
This study aims at assessing the feasibility of Probe-based Confocal Laser Endomicroscopy (pCLE) during laparoscopic hepatic masses resection for intra-operative characterisation of hepatic masses and surgical margins assessment.
Detailed description
Colorectal cancer is the third most common cancer and third leading cause of cancer deaths in the Western countries. In France, 45.000 new patients develop colorectal cancer every year. The liver is the most common organ targeted by CRLM, representing 50%. Approximately, 15-25% of colorectal cancer patients have synchronous CRLM at initial workup, and 20-30% patients sustain subsequent liver metastases within few years following diagnosis.
The strategy for colorectal cancer liver metastasis resection and liver cancer has evolved to a parenchymatic sparing procedure. This technic aims to minimize surgical margins width while removing the tumor. Therefore, the current standard for resection margins is a margin width superior to 1mm. However, there is still a debate concerning the margin width. Indeed, with modern chemotherapy, several studies reported no statistical differences in the overall survival between R0 patients and R1 patients treated with chemotherapy. However, in order to preserve patients from chemotherapy treatments' adverse effects an intra-operative microscopic assessment of surgical margins should be set up in order to reduce R1 margins occurrence.
Ex vivo study:
Surgical specimens obtained during hepatectomy will be imaged to generate an atlas of pCLE images.
In vivo study:
Intraoperative characterization of sub-capsular hepatic masses and surgical margins will be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Confocal Laser Endomicroscopy | Experimental | Device: Confocal Laser Endomicroscopylt includes patients will undergo probe-based Confocal Laser Endomicroscopy during laparoscopic hepatic masses resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years
- Scheduled for a surgical resection of hepatic masses
- Provided signed informed consent
Key exclusion criteria (3 listed)
- Allergy to Indocyanine green (ICG)
- Kidney failure
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Confocal Laser EndomicroscopyAlso: probe-based Confocal Laser Endomicroscopy, CelioFlex UHD 5 probe, Viziobot-P, GastroFlex UHD probeThe study is divided in two parts. For the two parts, patients will receive an intravenous injection of indocyanine green: 1. Ex vivo study - Images/sequences of normal and abnormal hepatic tissues and surgical margins will be acquired on surgical specimens 2. In vivo study - Intra-operative pCLE imaging will be performed on hepatic masses and surgical margins | Device | Confocal Laser Endomicroscopy |
Primary outcome
malignant pCLE criteria
Time frame: 1 year
Definition of pCLE criteria for normal and malignant hepatic tissues
6 secondary outcomes
pathological pCLE criteria
Time frame: 1 year
Ease of use of the endomicroscopy device
Time frame: 1 year
Audio/video telecommunication quality
Time frame: 1 year
Number of participants with CLE imaging-related adverse events as assessed by CTCAE v5.0
Time frame: 1 year
Stability and reproducibility of images/sequences during procedures
Time frame: 1 year
pCLE criteria diagnostic performance
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Confocal Laser Endomicroscopy in people with Hepatocarcinoma and Hepatic Metastasis, run by Mauna Kea Technologies 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 3 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 24 Jan 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
malignant pCLE criteria (time frame: 1 year). 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 24 Jan 2019.