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

Amsterdam UMC, location VUmc

Status: Completed

Conditions: Sentinel Lymph Node; Metastasis; Colorectal Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02122523

SLN

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

25 participants in 2 patient groups

SLN identification with NIR-dye-subserosa injection

Experimental group

Description:

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.

Treatment:

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

SLN identification with NIR-dye-submucosal injection

Active Comparator group

Description:

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.

Treatment:

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