Cancer of Digestive System, Ovarian Cancer
Conditions
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
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
Interventions
DEVICEconfocal laser endomicroscopy
probe-based and needle-based confocal laser endomicroscopy
Sponsors
Mauna Kea Technologies
Institut Mutualiste Montsouris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of participants with adverse events, their type and severity | 8 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| the quality of real time communication between the pathologist lab and the OR (grade 1 to 5) | 8 months | during or after each procedure, the surgeon and the pathologists are asked to assess the quality of audiovisual communication |
| number of interpretable images per organ, per contrast agent and per pathology | 8 months | 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. |
Countries
France
Outcome results
None listed