NCT03718078

Robotic Endomicroscopy to Better Define Resection Strategies Applied to Hepatic Surgery

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Mauna Kea Technologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2019-03-01
• Primary completion: 2020-01-07
• Completion: 2020-01-07
• First posted: 2018-10-24
• Last updated: 2019-01-24

Locations

1 site across 1 country: France