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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02122523
• Other study ID #: SLN
• Status: Completed
• Phase: N/A
• First received: March 19, 2014
• Last updated: April 23, 2014
• Start date: January 2013

Study information

• Verified date: April 2014
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Metastasis
• Sentinel Lymph Node

Intervention

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

Locations

Country	Name	City	State
Netherlands	VU University Medical Center	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of fluorescent lymph nodes		4 hours	No
Secondary	Number of Lymph nodes with metastasis		4 hours	No