Sentinel Node Mapping With Indocyanine Green in Colon Cancer: a Feasibility Trial and a Descriptive Serie.

Study Overview
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Brief Summary
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This study is a clinical feasibility trial that will contribute to the clarification of whether sentinel node mapping with indocyanine green (ICG) provides a better basis for staging of colorectal cancer.

Detailed Description
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The patients assigned for colon cancer will be operated as planned using laparoscopic techniques and the operation follows the normal procedure, in addition a sentinel node mapping is performed. Indocyanine green is injected around the tumor by laparoscopic technique, the fluorescence is controlled and after 20 minutes the surgeon looks for sentinel nodes in a standardized manner. In the meantime, the surgeon proceeds with the operation as usual, except that the mesocolon can be resected only after sentinel node mapping has been performed. After surgery the surgeon and the pathologist inspect the resected colon together and agree on D1, D2 and D3 margins. Any marked sentinel node(s) is verified and the location is checked on the colon diagram on the case report form. In addition, an ex vivo sentinel node mapping will be performed by the pathologist right after the surgery has ended. This is done to investigate if it is the same lymph nodes there will be identified by ex vivo as by intraoperative (in vivo) sentinel node mapping. The lymph nodes in the resected colon and mesocolon are all analysed. Sentinel nodes and an equal number of randomly chosen non-sentinel nodes will be analysed further with additional sections and immune histochemistry.

Official Title
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Sentinel Node Mapping With Indocyanine Green in Colon Cancer: a Feasibility Trial and a Descriptive Serie.

Conditions
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Colon Cancer, Lymphatic Metastasis

Intervention / Treatment
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* Procedure: Sentinel node mapping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients above 18 years of age scheduled for laparoscopic colon cancer surgery in the department of Surgery, Herlev Hospital or Roskilde Hospital. Exclusion Criteria: iodine allergy Poor kidney function (as it imply an increased risk of allergic reaction), estimated glomerular filtration rate should be above 40 ml/min. Liver cirrhosis, Child-Pugh-score B and C [14] Pregnancy and lactation Previous anaphylactic reaction to a dye injection Previous abdominal surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sentinel node mapping<br>Sentinel node mapping with indocyanine green injected orally and anally to the tumor. | Procedure: Sentinel node mapping<br>* Through transabdominal access via laparoscopic ports indocyanine green solution is injected around the tumor (25 mg indocyanine green dissolved in 9 ml sterile water and 1 ml 20% human albumin). This is done by the construction of two small boluses of 0.5 mL each into the colonic wall just orally and anally to the tumor margin, but not within the tumor itself. When the bolus is injected the fluorescence is controlled and after 20 minutes the surgeon looks for sentinel nodes in a standardized manner.<br>* Other names: Single use aspiration needle, NA-220H-8025 from Olympus.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of procedures with successful identification of sentinel nodes | Sentinel nodes is defined as the lymph node, first in line, draining from the cancer. | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of sentinel nodes identified during surgery and their localization |  | day 1 | 
| Number of sentinel nodes identified by ex vivo sentinel node mapping |  | week 1 | 
| Malignant status of the sentinel node(s) |  | week 1 | 
| Malignant status of the lymph nodes |  | week 1 | 
| Number of cases with negative sentinel node, but positive non-sentinel node |  | week 1 | 
| Localization of sentinel nodes with metastasis |  | week 1 | 
| Localization of lymph nodes with metastasis according to D1, D2 and D3 resection lines and if they are within 1 cm from a sentinel node |  | week 1 | 
| Number of cases where the sentinel node procedure has changed the clinical course of the patient | if staging and oncological treatment are changed because of the procedure | week 1 | 
| Number of procedures where the procedure is stopped due to technical reasons |  | day 1 | 
| Registration of possible side effects occurring due to the use of indocyanine green |  | day 1 | 
| Number of sentinel nodes identified by only one of the sentinel node mapping techniques |  | week 1 | 
| Total number of lymph nodes |  | week 1 | 
| Localization of the identified sentinel nodes, and whether or not they are included within the normal resection lines |  | week 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICG, Sentinel node mapping, lymphatic mapping, lymphatic metastasis, Aberrant lymphatic drainage, indocyanine green, near infrared, colon cancer, laparoscopic surgery