Colon Carcinoma, Lymph Node Metastases
Conditions
Keywords
indocyanine green, lymphatic mapping, fluorescence
Brief summary
The aim of the study is to evaluate whether lymph nodes draining the region of the carcinoma are located only inside the lines of standard resection or in some percentages are located outside as well. The visualized nodes draining the region of the carcinoma will be correlated to location, fluorescent yes/no and nodal positive/negative. The draining lymph nodes will be visualized using the fluorescent dye indocyanine green. The aim of the study is to evaluate whether lymph nodes draining the region of the carcinoma are located only inside the lines of standard resection or in some percentages are located outside as well. The visualized nodes draining the region of the carcinoma will be correlated to location, fluorescent yes/no and nodal positive/negative. The draining lymph nodes will be visualized using the fluorescent dye indocyanine green.
Detailed description
Participants with a diagnosed (andeno)carcinoma of the ascending, transverse, descending and sigmoid colon will be included. Preoperatively the participants will receive an indocyanine green(ICG) injection at four points around the tumour endoscopically. The ICG marking will take place one to five days prior to surgery. In the draining lymph nodes of the specific region the ICG will accumulate and thus visible via fluorescence-camera during the surgery. Intraoperatively, the precise locations of all fluorescent nodes will be documented photographically. A standard resection and lymph node dissection will be conducted, potential fluorescent nodes outside the standard resection lines will additionally be resected. The fresh specimen will then be measured, the fluorescent nodes marked and after the pathologic examination the nodes will be correlated to location, fluorescent yes/no and nodal positive/negative. The aim ist not the visualization of the Sentinel node or the directly draining lymphatic vessel but all the nodes draining the peritumorous region at the point of surgery.
Interventions
PROCEDUREICG-marking endoscopically
Preoperatively the participants will receive an endoscopic marking at four points around the tumour with the fluorescent dye indocyanine green.
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Intervention group. Participants will receive a state of the art surgical procedure with additional lymph node mapping
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* histologically diagnosed carcinoma of the ascending, transverse, descending or sigmoid colon.
Exclusion criteria
* not wanting to participate * other carcinoma then adenocarcinoma * endoscopic marking not possible
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative ICG-positive lymph nodes in vivo after endoscopic marking of the tumour | intraoperative assessment | Counting ICG-positive sites intraoperatively |
| Video-analysis of ICG-positive lymph nodes in vivo after endoscopic marking of the tumour | video-analysis within one week after surgery | Counting ICG-positive sites video-analysis |
| Number of ICG-positive lymph nodes after endoscopic marking of the tumour | within one week after surgery | Picking ICG-positive lymph nodes ex vivo in unfixed specimen, sending ICG positive nodes separately to pathological examination |
| Correlation of nodal-positive lymph nodes inside/outside the standard resection area | within one week after surgery | ICG-positive sites outside standard resection area will be cherry picked, sent to pathological examination separatively. |
Countries
Germany
Contacts
Primary ContactKatharina L Lucas, MD
Backup ContactJulia-Kristin Grass, Dr.
Outcome results
None listed