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

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ClinicalTrials.gov Identifier: NCT02167087
Recruitment Status : Completed
First Posted : June 18, 2014
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Ismail Gögenür, Herlev Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colon Cancer Lymphatic Metastasis Procedure: Sentinel node mapping Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Sentinel Node Mapping With Indocyanine Green in Colon Cancer: a Feasibility Trial and a Descriptive Serie.
Study Start Date : March 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Sentinel node mapping
Sentinel node mapping with indocyanine green injected orally and anally to the tumor.
 Procedure: Sentinel node mapping
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.
Other Names:
  • Karl Storz ICG system, to visualize the fluorescence
  • Indocyanine green, PULSION medical systems.
  • Single use aspiration needle, NA-220H-8025 from Olympus.


Outcome Measures
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Primary Outcome Measures :
  1. Number of procedures with successful identification of sentinel nodes [ Time Frame: day 1 ]
    Sentinel nodes is defined as the lymph node, first in line, draining from the cancer.


Secondary Outcome Measures :
  1. Number of sentinel nodes identified during surgery and their localization [ Time Frame: day 1 ]
  2. Number of sentinel nodes identified by ex vivo sentinel node mapping [ Time Frame: week 1 ]
  3. Malignant status of the sentinel node(s) [ Time Frame: week 1 ]
  4. Malignant status of the lymph nodes [ Time Frame: week 1 ]
  5. Number of cases with negative sentinel node, but positive non-sentinel node [ Time Frame: week 1 ]
  6. Localization of sentinel nodes with metastasis [ Time Frame: week 1 ]
  7. 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 [ Time Frame: week 1 ]
  8. Number of cases where the sentinel node procedure has changed the clinical course of the patient [ Time Frame: week 1 ]
    if staging and oncological treatment are changed because of the procedure

  9. Number of procedures where the procedure is stopped due to technical reasons [ Time Frame: day 1 ]
  10. Registration of possible side effects occurring due to the use of indocyanine green [ Time Frame: day 1 ]
  11. Number of sentinel nodes identified by only one of the sentinel node mapping techniques [ Time Frame: week 1 ]
  12. Total number of lymph nodes [ Time Frame: week 1 ]
  13. Localization of the identified sentinel nodes, and whether or not they are included within the normal resection lines [ Time Frame: week 1 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02167087


Locations
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Denmark
Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Ismail Gögenür
Investigators
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Principal Investigator: Ismail Gögenur, Professor Professor at University Hospital Køge
More Information
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Responsible Party: Ismail Gögenür, Professor, DMSc, MD, Herlev Hospital
ClinicalTrials.gov Identifier: NCT02167087    
Other Study ID Numbers: SENSE2014
First Posted: June 18, 2014    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ismail Gögenür, Herlev Hospital:
Sentinel node mapping
lymphatic mapping
lymphatic metastasis
Aberrant lymphatic drainage
indocyanine green
 ICG
near infrared
colon cancer
laparoscopic surgery
Additional relevant MeSH terms:
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Neoplasm Metastasis
Colonic Neoplasms
Lymphatic Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Colorectal Neoplasms
Intestinal Neoplasms
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases