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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Cancer of Digestive System, Ovarian Cancer

Intervention / Treatment
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* Device: confocal laser endomicroscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: confocal laser endomicroscopy<br>confocal laser endomicroscopy : 10 to 15 minutes endomicroscopy procedure to obtain real time microscopical images of healthy and malignant tissue of the targeted organs | Device: confocal laser endomicroscopy<br>* probe-based and needle-based confocal laser endomicroscopy<br>* Other names: Cellvizio;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants with adverse events, their type and severity |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ease of manipulation of the robotized probe (grade 1 to 5) | during or after each procedure, the surgeon is asked to assess the ease of manipulation of the device | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endomicroscopy, optical biopsy, exploratory surgery, resection surgery, robot-assisted, peritoneum carcinosis, inflammatory, rectum cancer, liver cancer, ovarian cancer, digestive cancer, pancreas cancer, duodenum cancer