Robotic Endomicroscopy to Better Define Resection Strategies Applied to Hepatic Surgery (PERSEE)

Mauna Kea Technologies

Status: Unknown

Conditions: Hepatic Metastasis; Hepatocarcinoma; Hepatic Tumor

Treatments: Device: Confocal Laser Endomicroscopy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03718078

2018-A02619-46 (Other Identifier)

MKT-2018-PERSEE-02-DIG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Confocal Laser Endomicroscopy

Experimental group

Description:

lt includes patients will undergo probe-based Confocal Laser Endomicroscopy during laparoscopic hepatic masses resection.

Treatment:

Device: Confocal Laser Endomicroscopy