Lymph Node Metastases Clinical Trial
Official title:
Lymph Node Mapping Via the Flourescent Dye ICG in Colon Cancer Through Preoperative Application
NCT number | NCT04959604 |
Other study ID # | CCLNM |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 31, 2021 |
Est. completion date | December 30, 2026 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 30, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University of Hamburg Medical Institutions | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraoperative ICG-positive lymph nodes in vivo after endoscopic marking of the tumour | Counting ICG-positive sites intraoperatively | intraoperative assessment | |
Primary | Video-analysis of ICG-positive lymph nodes in vivo after endoscopic marking of the tumour | Counting ICG-positive sites video-analysis | video-analysis within one week after surgery | |
Primary | 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 | within one week after surgery | |
Primary | 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. | within one week after surgery |
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