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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02122523
Other study ID # SLN
Secondary ID
Status Completed
Phase N/A
First received March 19, 2014
Last updated April 23, 2014
Start date January 2013

Study information

Verified date April 2014
Source VU University Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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


Locations

Country Name City State
Netherlands VU University Medical Center Amsterdam Noord-Holland

Sponsors (1)

Lead Sponsor Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of fluorescent lymph nodes 4 hours No
Secondary Number of Lymph nodes with metastasis 4 hours No
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