Status
Conditions
About
Evaluation of the possibility to detect sentinel lymph node(s) after ex vivo Indocyanine Green injections around the tumour in pieces of colectomy from patients with colon cancer.
Full description
Primary objective Feasibility study of ex vivo injections of ICG to image and detect the sentinel lymph nodes in patients with colon cancer.
Secondary objectives:
To determine the sensitivity of ICG in the dissected piece of colon cancer compared with the blue dye.
Tertiary objectives:
Evaluation of the influence of this approach on the up-staging of the patients
Microscopic study of the ICG distribution in the lymph nodes (in the lymphatic sinuses, in specific cells, in cancerous foci...)
Methodology:
In the operating room:
Patients will undergo standard surgical resection. Immediately after removal of the colon and node-bearing mesentery, using different 29 Gauge insulin syringes, blue dye (2 ml blue dye: 0.5 ml per injection) and ICG (2 ml with 0,5 mg ICG per ml: 0.5 ml per injection) will be injected in the fresh specimen beside each other submucosally around the tumour in at least four sites (as many injections needed to cover all the perimeter of the tumour) for each agent. The injection sites will be then gently stretched and massaged for 3-5 min to stimulate the tracers to flow along the lymphatic channels. Fluoroscopic imagings of the mesentery will be performed during the injections and during these manoeuvers.
The research and identification of the sentinel lymph nodes will be then performed as follows:
Histopathology in the Laboratory of Pathology:
When all SLN are identified, they will be dissected and classified as follows:
After the dissection of these SLN, the specimen will be processed as usual using routine procedure for further examination of the non SLN by the pathologists. Once these lymph nodes are dissected, they will be tested for the emitted fluorescence.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal