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

Not Applicable

Completed

• Conditions: Cancer of Digestive System; Ovarian Cancer
• Interventions: Device: confocal laser endomicroscopy

• Registration Number: NCT02312167
• Lead Sponsor: Institut Mutualiste Montsouris

Brief Summary

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

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

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-11-28
• Status Verified: 2014-12
• Study First Submitted QC: 2014-12-05
• Study First Posted: 2014-12-09
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2016-02-10
• Last Update Posted: 2016-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
confocal laser endomicroscopy	confocal laser endomicroscopy	confocal laser endomicroscopy : 10 to 15 minutes endomicroscopy procedure to obtain real time microscopical images of healthy and malignant tissue of the targeted organs

Primary Outcome Measures

Name	Time	Method
The number of participants with adverse events, their type and severity	8 months

Secondary Outcome Measures

Name	Time	Method
The ease of manipulation of the robotized probe (grade 1 to 5)	8 months	during or after each procedure, the surgeon is asked to assess the ease of manipulation of the device

Trial Locations

Locations (1)

Mutualiste Montsouris Institute; 🇫🇷 Paris, France