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

Study Overview
=================
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.

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

Conditions
-----------------
Metastasis, Sentinel Lymph Node, Colorectal Cancer

Intervention / Treatment
-----------------
* Procedure: Near-Infrared (NIR) dye Indocyanin Green (ICG)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SLN identification with NIR-dye-subserosa injection<br>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)<br> <br> |
| Active Comparator: SLN identification with NIR-dye-submucosal injection<br>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)<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of fluorescent lymph nodes |  | 4 hours | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Image guided surgery