Clinical trial NCT03718078: Robotic Endomicroscopy to Better Define Resection Strategies Applied to Hepatic Surgery
Official title: Essai Clinique Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d'ExérèsE (PERSÉE) appliquée à la Chirurgie Hépatique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocarcinoma
Hepatic Metastasis
Hepatic Tumor
Lead sponsor: Mauna Kea Technologies
Sponsor class: INDUSTRY
First posted: 2018-10-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: malignant pCLE criteria
timeFrame: 1 year
Secondary outcomes:
measure: pathological pCLE criteria
timeFrame: 1 year
measure: Ease of use of the endomicroscopy device
timeFrame: 1 year
measure: Audio/video telecommunication quality
timeFrame: 1 year
measure: Number of participants with CLE imaging-related adverse events as assessed by CTCAE v5.0
timeFrame: 1 year
measure: Stability and reproducibility of images/sequences during procedures
timeFrame: 1 year
measure: pCLE criteria diagnostic performance
timeFrame: 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Mutualiste Montsouris
Study officials:
References: