Back to resultsFeasibility Study for Robotic Endomicroscopy to Better Define Resection Strategies (PERSEE) (PERSEE)
Primary Purpose
Cancer of Digestive System, Ovarian Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
confocal laser endomicroscopy
Sponsored by
About this trial
This is an interventional treatment trial for Cancer of Digestive System focused on measuring endomicroscopy, optical biopsy, exploratory surgery, resection surgery, robot-assisted, peritoneum carcinosis, inflammatory, rectum cancer, liver cancer, ovarian cancer, digestive cancer, pancreas cancer, duodenum cancer
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
Sites / Locations
- Mutualiste Montsouris Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
confocal laser endomicroscopy
Arm Description
confocal laser endomicroscopy : 10 to 15 minutes endomicroscopy procedure to obtain real time microscopical images of healthy and malignant tissue of the targeted organs
Outcomes
Primary Outcome Measures
The number of participants with adverse events, their type and severity
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02312167
First Posted
November 28, 2014
Last Updated
February 10, 2016
Sponsor
Institut Mutualiste Montsouris
Collaborators
Mauna Kea Technologies
1. Study Identification
Unique Protocol Identification Number
NCT02312167
Brief Title
Feasibility Study for Robotic Endomicroscopy to Better Define Resection Strategies (PERSEE)
Acronym
PERSEE
Official Title
Essai de faisabilité Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d&Apos;ExérèsE
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Mutualiste Montsouris
Collaborators
Mauna Kea Technologies
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
confocal laser endomicroscopy
Arm Type
Experimental
Arm Description
confocal laser endomicroscopy : 10 to 15 minutes endomicroscopy procedure to obtain real time microscopical images of healthy and malignant tissue of the targeted organs
Intervention Type
Device
Intervention Name(s)
confocal laser endomicroscopy
Other Intervention Name(s)
optical biopsy, Cellvizio
Intervention Description
probe-based and needle-based confocal laser endomicroscopy
Primary Outcome Measure Information:
Title
The number of participants with adverse events, their type and severity
Time Frame
8 months
Secondary Outcome Measure Information:
Title
The ease of manipulation of the robotized probe (grade 1 to 5)
Description
during or after each procedure, the surgeon is asked to assess the ease of manipulation of the device
Time Frame
8 months
Other Pre-specified Outcome Measures:
Title
the quality of real time communication between the pathologist lab and the OR (grade 1 to 5)
Description
during or after each procedure, the surgeon and the pathologists are asked to assess the quality of audiovisual communication
Time Frame
8 months
Title
number of interpretable images per organ, per contrast agent and per pathology
Description
each sequence acquired during the cases will be annotated as to which organ it is, and the final diagnosis of the specimen (healthy, cancerous, inflammation, etc ...). Thanks to this, a more complete atlas of images obtained in digestive organs and conditions will be developed. This atlas will be used to describe image interpretation criteria for endomicroscopic images of various organs and conditions. This work will be done in conjunction by the investigators, the histopathologist, and an Mauna Kea Technologies representative familiar with image interpretation in current endomicroscopy indications.
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brice GAYET, MD
Organizational Affiliation
Mutualiste Montsouris Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mutualiste Montsouris Institute
City
Paris
ZIP/Postal Code
75014
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
30232616
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.
Results Reference
derived
Learn more about this trial
Feasibility Study for Robotic Endomicroscopy to Better Define Resection Strategies (PERSEE)
We'll reach out to this number within 24 hrs