Lymph Node Mapping Via Flourescent Dye in Colon Cancer

NCT04959604 | Recruiting

• 1 other identifier: CCLNM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colon Carcinoma; Lymph Node Metastases

Keywords

indocyanine green; lymphatic mapping; fluorescence

Outcome Measures

Primary Outcomes (4)

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

  Counting ICG-positive sites intraoperatively

  intraoperative assessment

• 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

• 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

• 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

Study Arms (1)

ICG-marked Colon Carcinoma

EXPERIMENTAL

The participants will receive an endoscopic marking via ICG preoperatively

Procedure: ICG-marking endoscopically

Interventions

ICG-marking endoscopically PROCEDURE

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

ICG-marked Colon Carcinoma

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University of Hamburg Medical Institutions

Hamburg, Germany

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Perez, Prof. Dr.

  Dept of General Visceral and Thoracic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katharina L Lucas, MD

CONTACT

+4915779600815; katharina.lucas@uni-wh.de

Julia-Kristin Grass, Dr.

CONTACT

+4915222815011; j.grass@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention group. Participants will receive a state of the art surgical procedure with additional lymph node mapping

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 13, 2021
• Study Start: May 31, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)