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
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 19, 2014
CompletedFirst Posted
Study publicly available on registry
April 24, 2014
CompletedApril 24, 2014
April 1, 2014
1 year
March 19, 2014
April 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of fluorescent lymph nodes
4 hours
Secondary Outcomes (1)
Number of Lymph nodes with metastasis
4 hours
Study Arms (2)
SLN identification with NIR-dye-subserosa injection
EXPERIMENTALNear-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.
SLN identification with NIR-dye-submucosal injection
ACTIVE COMPARATORNear-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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VU University Medical Center
Amsterdam, North Holland, 1081HV, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 19, 2014
First Posted
April 24, 2014
Study Start
January 1, 2013
Primary Completion
January 1, 2014
Last Updated
April 24, 2014
Record last verified: 2014-04