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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2014

Interventions

  • Procedure: Near-Infrared (NIR) dye Indocyanin Green (ICG)

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Number of fluorescent lymph nodes
    • Time Frame: 4 hours

Secondary Measures

  • Number of Lymph nodes with metastasis
    • Time Frame: 4 hours

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Amsterdam UMC, location VUmc
  • Provider of Information About this Clinical Study
    • Principal Investigator: M.Ankersmit, MD – Amsterdam UMC, location VUmc

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