Robotic Endomicroscopy to Better Define Resection Strategies Applied to Hepatic Surgery

Hepatocarcinoma Clinical Trial

— PERSEE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03718078
• Other study ID #: MKT-2018-PERSEE-02-DIG
• Secondary ID: 2018-A02619-46
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2019
• Est. completion date: January 7, 2020

Study information

• Verified date: January 2019
• Source: Mauna Kea Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 7, 2020
• Est. primary completion date: January 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatic Metastasis
• Hepatic Tumor
• Hepatocarcinoma
• Liver Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Institut Mutualiste Montsouris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Mauna Kea Technologies

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	malignant pCLE criteria	Definition of pCLE criteria for normal and malignant hepatic tissues	1 year
Secondary	pathological pCLE criteria	Definition of pCLE criteria for pathological hepatic parenchyma (non tumoral)	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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