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

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.

Study Overview

• Status: Unknown
• Conditions: Hepatocarcinoma; Hepatic Tumor; Hepatic Metastasis
• Intervention / Treatment: Device: Confocal Laser Endomicroscopy

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Institut Mutualiste Montsouris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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

What is the study measuring?

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
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
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
pathological pCLE criteria	Definition of pCLE criteria for pathological hepatic parenchyma (non tumoral)	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
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

Collaborators and Investigators

• Sponsor: Mauna Kea Technologies

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2019
• Primary Completion (Anticipated): January 7, 2020
• Study Completion (Anticipated): January 7, 2020

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (Actual): October 24, 2018

Study Record Updates

• Last Update Posted (Actual): January 24, 2019
• Last Update Submitted That Met QC Criteria: January 23, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Carcinoma, Hepatocellular; Liver Neoplasms
• Other Study ID Numbers: MKT-2018-PERSEE-02-DIG; 2018-A02619-46 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No