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

Not Applicable

Completed

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

• Registration Number: NCT02122523
• Lead Sponsor: Amsterdam UMC, location VUmc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2014-01
• Study First Submitted: 2014-03-19
• Status Verified: 2014-04
• Study First Submitted QC: 2014-04-23
• Last Update Submitted: 2014-04-23
• Study First Posted: 2014-04-24
• Last Update Posted: 2014-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SLN identification with NIR-dye-subserosa injection	Near-Infrared (NIR) dye Indocyanin Green (ICG)	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.
SLN identification with NIR-dye-submucosal injection	Near-Infrared (NIR) dye Indocyanin Green (ICG)	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.

Primary Outcome Measures

Name	Time	Method
Number of fluorescent lymph nodes	4 hours

Secondary Outcome Measures

Name	Time	Method
Number of Lymph nodes with metastasis	4 hours

Trial Locations

Locations (1)

VU University Medical Center; 🇳🇱 Amsterdam, Noord-Holland, Netherlands