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Completed

NCT Number: NCT02167087

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

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lymphatic Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herlev Hospital

Herlev, 2730, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sentinel node mapping

Procedure

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ismail Gögenür

Other

Registry information

Acronym: SENSE

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 18, 2014
Registry last updated
Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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