Lymph Node Mapping Via Flourescent Dye in Colon Cancer

Lymph Node Metastases Clinical Trial

Official title:

Lymph Node Mapping Via the Flourescent Dye ICG in Colon Cancer Through Preoperative Application

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04959604
• Other study ID #: CCLNM
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Colon Carcinoma
• Lymph Node Metastases
• Lymphatic Metastasis

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