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

Sponsor

Amsterdam UMC, location VUmc (Other)

Overall Status

Completed

CT.gov ID

NCT02122523

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sentinel Lymph Node Colorectal Cancer Metastasis	Procedure: Near-Infrared (NIR) dye Indocyanin Green (ICG)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Jan 1, 2014

Arms and Interventions

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)

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

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

Outcome Measures

Primary Outcome Measures

Number of fluorescent lymph nodes [4 hours]

Secondary Outcome Measures

Number of Lymph nodes with metastasis [4 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VU University Medical Center	Amsterdam	Noord-Holland	Netherlands	1081HV

Sponsors and Collaborators

Amsterdam UMC, location VUmc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

M.Ankersmit, MD, Amsterdam UMC, location VUmc

ClinicalTrials.gov Identifier:

NCT02122523

Other Study ID Numbers:

First Posted:

Apr 24, 2014

Last Update Posted:

Apr 24, 2014

Last Verified:

Apr 1, 2014

Keywords provided by M.Ankersmit, MD, Amsterdam UMC, location VUmc

Image guided surgery

Additional relevant MeSH terms:

Carcinoma

Colorectal Neoplasms

Study Results

No Results Posted as of Apr 24, 2014