Clinical trial NCT02312167: Feasibility Study for Robotic Endomicroscopy to Better Define Resection Strategies (PERSEE)
Official title: Essai de faisabilité Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d&Apos;ExérèsE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Digestive System
Ovarian Cancer
Keywords: endomicroscopy
optical biopsy
exploratory surgery
resection surgery
robot-assisted
peritoneum carcinosis
inflammatory
rectum cancer
liver cancer
ovarian cancer
digestive cancer
pancreas cancer
duodenum cancer
Lead sponsor: Institut Mutualiste Montsouris
Sponsor class: OTHER
Collaborators: name: Mauna Kea Technologies
First posted: 2014-12-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: The number of participants with adverse events, their type and severity
timeFrame: 8 months
Secondary outcomes:
measure: The ease of manipulation of the robotized probe (grade 1 to 5)
timeFrame: 8 months
Other outcomes:
measure: the quality of real time communication between the pathologist lab and the OR (grade 1 to 5)
timeFrame: 8 months
measure: number of interpretable images per organ, per contrast agent and per pathology
timeFrame: 8 months
Locations:
city: Paris
country: France
facility: Mutualiste Montsouris Institute
Study officials:
affiliation: Mutualiste Montsouris Institute
name: Brice GAYET, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fuks D, Pierangelo A, Validire P, Lefevre M, Benali A, Trebuchet G, Criton A, Gayet B. Intraoperative confocal laser endomicroscopy for real-time in vivo tissue characterization during surgical procedures. Surg Endosc. 2019 May;33(5):1544-1552. doi: 10.1007/s00464-018-6442-3. Epub 2018 Sep 19.