Robotic Endomicroscopy to Better Define Resection Strategies Applied to Hepatic Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Essai Clinique Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d'ExérèsE (PERSÉE) appliquée à la Chirurgie Hépatique

Conditions
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Hepatocarcinoma, Hepatic Metastasis, Hepatic Tumor

Intervention / Treatment
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* Device: Confocal Laser Endomicroscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Confocal Laser Endomicroscopy<br>lt includes patients will undergo probe-based Confocal Laser Endomicroscopy during laparoscopic hepatic masses resection. | Device: Confocal Laser Endomicroscopy<br>* 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<br>* Other names: Confocal Miniprobes;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| malignant pCLE criteria | Definition of pCLE criteria for normal and malignant hepatic tissues | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathological pCLE criteria | Definition of pCLE criteria for pathological hepatic parenchyma (non tumoral) | 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 | 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 | 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 | 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 | 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. | 1 year |