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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02122523

Enrollment

Registered

2014-04-24

Start date

2013-01-31

Completion date

Unknown

Last updated

2014-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Metastasis, Sentinel Lymph Node

Keywords

Image guided surgery

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.

Interventions

PROCEDURENear-Infrared (NIR) dye Indocyanin Green (ICG)

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Number of fluorescent lymph nodes	4 hours

Secondary

Measure	Time frame
Number of Lymph nodes with metastasis	4 hours

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026