Lymph Node Mapping Via Flourescent Dye in Colon Cancer
- Conditions
- Lymph Node MetastasesColon Carcinoma
- Interventions
- Procedure: ICG-marking endoscopically
- Registration Number
- NCT04959604
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- histologically diagnosed carcinoma of the ascending, transverse, descending or sigmoid colon.
- not wanting to participate
- other carcinoma then adenocarcinoma
- endoscopic marking not possible
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ICG-marked Colon Carcinoma ICG-marking endoscopically The participants will receive an endoscopic marking via ICG preoperatively
- Primary Outcome Measures
Name Time Method 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
Intraoperative ICG-positive lymph nodes in vivo after endoscopic marking of the tumour intraoperative assessment Counting ICG-positive sites intraoperatively
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Hamburg Medical Institutions
🇩🇪Hamburg, Germany