Feasibility Study for Robotic Endomicroscopy to Better Define Resection Strategies (PERSEE)

Essai de faisabilité Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d&Apos;ExérèsE

This study aims at demonstrating the feasibility of probe-based confocal laser endomicroscopy (pCLE) and needle-based confocal laser endomicroscopy (nCLE).

Contraindications for resection surgery may sometimes be missed during exploratory surgical procedures. That may lead to an incomplete thus useless surgery and delay the right treatment.

The objectives of this study are to improve the detection of cancer extension during exploratory procedures and to guide resection to ensure clear margins.

This study involves several innovations including :

• the robotization of the confocal miniprobe for a better an d more precise handling of the probe
• the use of different contrast agent and administration mode (Fluorescein, Patented Blue V, Indocyanine Green via intravenous, interstitial or topical administration)
• the communication between the operative room and the pathologist room for a real time assessment by the surgeon and by the pathologist of the endomicroscopic images

Inclusion Criteria:

• patient scheduled for an exploratory surgery or a resection surgery for an abdomino-pelvic cancer
• patient able to give written informed consent

Exclusion Criteria:

• allergy to fluorescein
• allergy to patented blue
• allergy to ICG
• previous life-threatening allergic reactions and known hypersensitivity
• pregnancy or breast-feeding
• history of cardio-pulmonary disease (including bronchial asthma)
• restricted renal function
• patient under a beta-blockers treatment
• patient who cannot give written informed consent