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Recruiting NCT04959604

Lymph Node Mapping Via Flourescent Dye in Colon Cancer

No phase Interventional Colon Carcinoma Lymph Node Metastases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ICG-marking endoscopically.
Who it may be relevant to
Registry conditions: Colon Carcinoma, Lymph Node Metastases. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed 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.

Interventions

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

Primary outcome measures

  • Intraoperative ICG-positive lymph nodes in vivo after endoscopic marking of the tumour [Time frame: intraoperative assessment]
  • Video-analysis of ICG-positive lymph nodes in vivo after endoscopic marking of the tumour [Time frame: video-analysis within one week after surgery]
  • Number of ICG-positive lymph nodes after endoscopic marking of the tumour [Time frame: within one week after surgery]
  • Correlation of nodal-positive lymph nodes inside/outside the standard resection area [Time frame: within one week after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 1 center
  • University of Hamburg Medical Institutions — Hamburg

Identifiers

NCT: NCT04959604 · CCLNM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗