Sentinel Lymph Node (SLN) in Colorectal Carcinoma (CRC) With a Near-infrared (NIR)-Dye

April 23, 2014 updated by: M.Ankersmit, Amsterdam UMC, location VUmc

In Vivo Study to Determine the Efficacy of Sentinel Node Mapping in Patients With Colon Carcinoma Using Near-infrared Laparoscopy

The sentinel lymph node (SLN) procedure is a standard staging technique in several types of cancer. One of the major problems of SLN mapping in colorectal cancer is the lack of an optimal dye and technique for identification of the nodes. In this study the investigators used the Near-Infrared (NIR) dye Indocyanin Green (ICG) to identify nodes with a newly developed NIR laparoscope. The investigators compared two different injection techniques; subserosal and submucosal injection.

Patients planned for a laparoscopic resection of a colorectal carcinoma without distant metastases were included. Dye was injected in the subserosa or submucosa of the bowel. Ten minutes after injection the investigators searched for fluorescent nodes with the NIR laparoscope. Fluorescent nodes were harvested and analyzed by the pathologist using H&E and additional immunohistochemistry.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081HV
        • VU University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Oral and written Informed Consent (IC)
  • Age 18 years and older
  • Patients histological or radiological suspicion of colon cancer
  • Surgical resection of the tumor
  • Regular Pre-operative work-up

Exclusion Criteria:

  • Gross lymph node involvement
  • Distant metastases
  • Advanced disease with invasion of adjacent structures
  • Prior colorectal surgery
  • Metastatic or T4 disease discovered during intraoperative staging
  • Contraindications to laparoscopy
  • Rectal cancer
  • Allergy to iodine
  • Patients at higher risk for anaphylactic reactions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SLN identification with NIR-dye-subserosa injection
Near-Infrared (NIR) dye Indocyanin Green (ICG) to identify nodes with a newly developed NIR laparoscope. The investigators compared two different injection techniques; subserosal and submucosal injection.
Procedure: Near-Infrared (NIR) dye Indocyanin Green (ICG)
Active Comparator: SLN identification with NIR-dye-submucosal injection
Near-Infrared (NIR) dye Indocyanin Green (ICG) to identify nodes with a newly developed NIR laparoscope. The investigators compared two different injection techniques; subserosal and submucosal injection.
Procedure: Near-Infrared (NIR) dye Indocyanin Green (ICG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of fluorescent lymph nodes
Time Frame: 4 hours
4 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Lymph nodes with metastasis
Time Frame: 4 hours
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amsterdam UMC, location VUmc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

March 19, 2014

First Submitted That Met QC Criteria

April 23, 2014

First Posted (Estimate)

April 24, 2014

Study Record Updates

Last Update Posted (Estimate)

April 24, 2014

Last Update Submitted That Met QC Criteria

April 23, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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