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

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: Colorectal Cancer; Metastasis; Sentinel Lymph Node
• Intervention / Treatment: Procedure: Near-Infrared (NIR) dye Indocyanin Green (ICG)

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	4 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc

Study record dates

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: Image guided surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Carcinoma; Colorectal Neoplasms
• Other Study ID Numbers: SLN