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NCT Number: NCT02122523

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

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.

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Key information

Conditions

Sentinel Lymph Node Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VU University Medical Center

Amsterdam, North Holland, 1081HV, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

Primary outcomes

  1. Number of fluorescent lymph nodes

    Time frame: 4 hours

Secondary outcomes

  1. Number of Lymph nodes with metastasis

    Time frame: 4 hours

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
First posted
Apr 24, 2014
Registry last updated
Apr 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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