Sentinel Lymph Node (SLN) in Colorectal Carcinoma (CRC) With a Near-infrared (NIR)-Dye
NCT ID: NCT02122523
Last Updated: 2014-04-24
Study Results
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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COMPLETED
NA
25 participants
INTERVENTIONAL
2013-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
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.
Near-Infrared (NIR) dye Indocyanin Green (ICG)
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.
Near-Infrared (NIR) dye Indocyanin Green (ICG)
Interventions
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Near-Infrared (NIR) dye Indocyanin Green (ICG)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Amsterdam UMC, location VUmc
OTHER
Responsible Party
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M.Ankersmit
MD
Locations
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VU University Medical Center
Amsterdam, North Holland, Netherlands
Countries
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Other Identifiers
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SLN
Identifier Type: -
Identifier Source: org_study_id
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