Robotic Endomicroscopy to Better Define Resection Strategies Applied to Hepatic Surgery

NCT ID: NCT03718078

Last Updated: 2019-01-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-31
• Study Completion Date: 2020-01-07

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.

Conditions

Hepatocarcinoma; Hepatic Metastasis; Hepatic Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Confocal Laser Endomicroscopy

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

Group Type: EXPERIMENTAL

Confocal Laser Endomicroscopy

Intervention Type: DEVICE

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

Interventions

Confocal 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

Intervention Type: DEVICE

Other Intervention Names

probe-based Confocal Laser Endomicroscopy; CelioFlex UHD 5 probe; Viziobot-P; GastroFlex UHD probe; Cellvizio 100 series; pCLE; Confocal Miniprobes

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mauna Kea Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Mutualiste Montsouris

Paris, , France

Countries

France

Facility Contacts

David Fuks, MD

Role: primary

Other Identifiers

2018-A02619-46

Identifier Type: OTHER

Identifier Source: secondary_id

MKT-2018-PERSEE-02-DIG

Identifier Type: -

Identifier Source: org_study_id