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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:

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.


Sponsor: Ismail Gögenür

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of sentinel nodes identified during surgery and their localization [ Time Frame: day 1 ]
  • Number of sentinel nodes identified by ex vivo sentinel node mapping [ Time Frame: week 1 ]
  • Malignant status of the sentinel node(s) [ Time Frame: week 1 ]
  • Malignant status of the lymph nodes [ Time Frame: week 1 ]
  • Number of cases with negative sentinel node, but positive non-sentinel node [ Time Frame: week 1 ]
  • Localization of sentinel nodes with metastasis [ Time Frame: 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 [ Time Frame: week 1 ]
  • 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
  • Number of procedures where the procedure is stopped due to technical reasons [ Time Frame: day 1 ]
  • Registration of possible side effects occurring due to the use of indocyanine green [ Time Frame: day 1 ]
  • Number of sentinel nodes identified by only one of the sentinel node mapping techniques [ Time Frame: week 1 ]
  • Total number of lymph nodes [ Time Frame: week 1 ]
  • Localization of the identified sentinel nodes, and whether or not they are included within the normal resection lines [ Time Frame: week 1 ]


Original Secondary Outcome:

  • Number of sentinel nodes identified during surgery and their localization [ Time Frame: day 1 ]
  • Total number of lymph nodes [ Time Frame: week 1 ]
  • Malignant status of the sentinel node(s) [ Time Frame: week 1 ]
  • Malignant status of the lymph nodes [ Time Frame: week 1 ]
  • Number of cases with negative sentinel node, but positive non-sentinel node [ Time Frame: week 1 ]
  • Localization of the identified sentinel nodes, and whether or not they are included within the normal resection lines [ Time Frame: day 1 ]
  • Localization of sentinel nodes with metastasis [ Time Frame: 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 [ Time Frame: week 1 ]
  • 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
  • Number of procedures where the procedure is stopped due to technical reasons [ Time Frame: day 1 ]
  • Registration of possible side effects occurring due to the use of indocyanine green [ Time Frame: day 1 ]


Information By: Herlev Hospital

Dates:
Date Received: June 6, 2014
Date Started: March 2015
Date Completion:
Last Updated: February 15, 2016
Last Verified: February 2016