Lymph Node Mapping Via the Flourescent Dye ICG in Colon Cancer Through Preoperative Application
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Video-analysis of ICG-positive lymph nodes in vivo after endoscopic marking of the tumour
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
ICG-marked Colon Carcinoma
The participants will receive an endoscopic marking via ICG preoperatively
Intervention: ICG-marking endoscopically (Procedure)
Outcomes
Primary Outcomes
Video-analysis of ICG-positive lymph nodes in vivo after endoscopic marking of the tumour
Time Frame: video-analysis within one week after surgery
Counting ICG-positive sites video-analysis
Intraoperative ICG-positive lymph nodes in vivo after endoscopic marking of the tumour
Time Frame: intraoperative assessment
Counting ICG-positive sites intraoperatively
Correlation of nodal-positive lymph nodes inside/outside the standard resection area
Time Frame: within one week after surgery
ICG-positive sites outside standard resection area will be "cherry picked", sent to pathological examination separatively.
Number of ICG-positive lymph nodes after endoscopic marking of the tumour
Time Frame: within one week after surgery
Picking ICG-positive lymph nodes ex vivo in unfixed specimen, sending ICG positive nodes separately to pathological examination
Secondary Outcomes
No secondary outcomes reported