Back to resultsSentinel Lymph Node (SLN) in Colorectal Carcinoma (CRC) With a Near-infrared (NIR)-Dye
Primary Purpose
Sentinel Lymph Node, Colorectal Cancer, Metastasis
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Near-Infrared (NIR) dye Indocyanin Green (ICG)
Sponsored by
About this trial
This is an interventional treatment trial for Sentinel Lymph Node focused on measuring Image guided surgery
Eligibility Criteria
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
Sites / Locations
- VU University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SLN identification with NIR-dye-subserosa injection
SLN identification with NIR-dye-submucosal injection
Arm Description
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) to identify nodes with a newly developed NIR laparoscope. The investigators compared two different injection techniques; subserosal and submucosal injection.
Outcomes
Primary Outcome Measures
Number of fluorescent lymph nodes
Secondary Outcome Measures
Number of Lymph nodes with metastasis
Full Information
NCT ID
NCT02122523
First Posted
March 19, 2014
Last Updated
April 23, 2014
Sponsor
Amsterdam UMC, location VUmc
1. Study Identification
Unique Protocol Identification Number
NCT02122523
Brief Title
Sentinel Lymph Node (SLN) in Colorectal Carcinoma (CRC) With a Near-infrared (NIR)-Dye
Official Title
In Vivo Study to Determine the Efficacy of Sentinel Node Mapping in Patients With Colon Carcinoma Using Near-infrared Laparoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sentinel Lymph Node, Colorectal Cancer, Metastasis
Keywords
Image guided surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SLN identification with NIR-dye-subserosa injection
Arm Type
Experimental
Arm Description
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.
Arm Title
SLN identification with NIR-dye-submucosal injection
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Near-Infrared (NIR) dye Indocyanin Green (ICG)
Primary Outcome Measure Information:
Title
Number of fluorescent lymph nodes
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Number of Lymph nodes with metastasis
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
VU University Medical Center
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081HV
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Sentinel Lymph Node (SLN) in Colorectal Carcinoma (CRC) With a Near-infrared (NIR)-Dye
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