Lymph Node Mapping Via Flourescent Dye in Colon Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversitätsklinikum Hamburg-Eppendorf
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
histologically diagnosed carcinoma of the ascending, transverse, descending or sigmoid colon.
Disqualifiers
not wanting to participate
other carcinoma then adenocarcinoma
endoscopic marking not possible
Trial design
Design model
Single group
Treatments tested in this trial
ICG-marking endoscopically
Procedure/SurgeryPreoperatively the participants will receive an endoscopic marking at four points around the tumour with the fluorescent dye indocyanine green.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: ICG-marked Colon CarcinomaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Intraoperative ICG-positive lymph nodes in vivo after endoscopic marking of the tumour
Counting ICG-positive sites intraoperatively
Time frame
intraoperative assessment2
Video-analysis of ICG-positive lymph nodes in vivo after endoscopic marking of the tumour
Counting ICG-positive sites video-analysis
Time frame
video-analysis within one week after surgery3
Number of ICG-positive lymph nodes after endoscopic marking of the tumour
Picking ICG-positive lymph nodes ex vivo in unfixed specimen, sending ICG positive nodes separately to pathological examination
Time frame
within one week after surgery4
Correlation of nodal-positive lymph nodes inside/outside the standard resection area
ICG-positive sites outside standard resection area will be "cherry picked", sent to pathological examination separatively.
Time frame
within one week after surgerySponsors and contacts
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Source ClinicalTrials.gov