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

NCT ID: NCT02122523

Last Updated: 2014-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sentinel Lymph Node Colorectal Cancer Metastasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

Interventions

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amsterdam UMC, location VUmc

OTHER

Sponsor Role lead

Responsible Party

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M.Ankersmit

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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VU University Medical Center

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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SLN

Identifier Type: -

Identifier Source: org_study_id

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