Hepatic Metastasis, Hepatic Tumor, Hepatocarcinoma
Conditions
Brief 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.
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.
Interventions
DEVICEConfocal Laser Endomicroscopy
The 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
Sponsors
Mauna Kea Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Over 18 years * Scheduled for a surgical resection of hepatic masses * Provided signed informed consent
Exclusion criteria
* Allergy to Indocyanine green (ICG) * Kidney failure * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| malignant pCLE criteria | 1 year | Definition of pCLE criteria for normal and malignant hepatic tissues |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of use of the endomicroscopy device | 1 year | 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 |
| Audio/video telecommunication quality | 1 year | The telecommunication quality will be assessed using a questionnaire that the surgeon and the anatomopathologist will fill at the end of each procedure |
| pathological pCLE criteria | 1 year | Definition of pCLE criteria for pathological hepatic parenchyma (non tumoral) |
| Stability and reproducibility of images/sequences during procedures | 1 year | 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 |
| pCLE criteria diagnostic performance | 1 year | The diagnostic performance of identified pCLE criteria will be expressed by their sensitivities, specificities, negative predictive value and positive predictive value. |
| Number of participants with CLE imaging-related adverse events as assessed by CTCAE v5.0 | 1 year | The device safety will be measured by assessing the occurence and severity of adverse events during the study |
Countries
France
Outcome results
None listed