Lymph Node Mapping Via Flourescent Dye in Colon Cancer

Last updated: May 21, 2023
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colon Cancer; Rectal Cancer

Treatment

ICG-marking endoscopically

Clinical Study ID

NCT04959604
CCLNM
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • histologically diagnosed carcinoma of the ascending, transverse, descending or sigmoidcolon.

Exclusion

Exclusion Criteria:

  • not wanting to participate
  • other carcinoma then adenocarcinoma
  • endoscopic marking not possible

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: ICG-marking endoscopically
Phase:
Study Start date:
May 31, 2021
Estimated Completion Date:
December 30, 2026

Study 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.

Connect with a study center

  • University of Hamburg Medical Institutions

    Hamburg,
    Germany

    Active - Recruiting

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