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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date May 2023
Source Universitätsklinikum Hamburg-Eppendorf
Contact Katharina L Lucas, MD
Phone +4915779600815
Email katharina.lucas@uni-wh.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

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

Study Design


Intervention

Procedure:
ICG-marking endoscopically
Preoperatively the participants will receive an endoscopic marking at four points around the tumour with the fluorescent dye indocyanine green.

Locations

Country Name City State
Germany University of Hamburg Medical Institutions Hamburg

Sponsors (1)

Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

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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