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NCT Number: NCT04959604

Lymph Node Mapping Via Flourescent Dye in Colon Cancer

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.

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Key information

Conditions

Colon Carcinoma Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lymph Node Metastases Lymphatic Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Hamburg Medical Institutions

Hamburg, Germany

Location status: Recruiting

Location contact

Julia-Kristin Grass, Dr.

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICG-marking endoscopically

Procedure

Preoperatively the participants will receive an endoscopic marking at four points around the tumour with the fluorescent dye indocyanine green.

Primary outcomes

  1. Intraoperative ICG-positive lymph nodes in vivo after endoscopic marking of the tumour

    Time frame: intraoperative assessment

    Counting ICG-positive sites intraoperatively

  2. Video-analysis of ICG-positive lymph nodes in vivo after endoscopic marking of the tumour

    Time frame: video-analysis within one week after surgery

    Counting ICG-positive sites video-analysis

  3. Number of ICG-positive lymph nodes after endoscopic marking of the tumour

    Time frame: within one week after surgery

    Picking ICG-positive lymph nodes ex vivo in unfixed specimen, sending ICG positive nodes separately to pathological examination

  4. Correlation of nodal-positive lymph nodes inside/outside the standard resection area

    Time frame: within one week after surgery

    ICG-positive sites outside standard resection area will be "cherry picked", sent to pathological examination separatively.

Study contacts

Contact information is provided by the study sponsor or research team.

Julia-Kristin Grass, Dr.

CONTACT

[email protected]

+4915222815011

Katharina L Lucas, MD

CONTACT

[email protected]

+4915779600815

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jul 13, 2021
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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