Clinical trial NCT02167087: Sentinel Node Mapping With Indocyanine Green in Colon Cancer: a Feasibility Trial and a Descriptive Serie.
Official title: Sentinel Node Mapping With Indocyanine Green in Colon Cancer: a Feasibility Trial and a Descriptive Serie.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Lymphatic Metastasis
Keywords: Sentinel node mapping
lymphatic mapping
lymphatic metastasis
Aberrant lymphatic drainage
indocyanine green
ICG
near infrared
colon cancer
laparoscopic surgery
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2014-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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.

Eligibility 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

Primary outcomes:
measure: Number of procedures with successful identification of sentinel nodes
timeFrame: day 1
Secondary outcomes:
measure: Number of sentinel nodes identified during surgery and their localization
timeFrame: day 1
measure: Number of sentinel nodes identified by ex vivo sentinel node mapping
timeFrame: week 1
measure: Malignant status of the sentinel node(s)
timeFrame: week 1
measure: Malignant status of the lymph nodes
timeFrame: week 1
measure: Number of cases with negative sentinel node, but positive non-sentinel node
timeFrame: week 1
measure: Localization of sentinel nodes with metastasis
timeFrame: week 1
measure: 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
timeFrame: week 1
measure: Number of cases where the sentinel node procedure has changed the clinical course of the patient
timeFrame: week 1
measure: Number of procedures where the procedure is stopped due to technical reasons
timeFrame: day 1
measure: Registration of possible side effects occurring due to the use of indocyanine green
timeFrame: day 1
measure: Number of sentinel nodes identified by only one of the sentinel node mapping techniques
timeFrame: week 1
measure: Total number of lymph nodes
timeFrame: week 1
measure: Localization of the identified sentinel nodes, and whether or not they are included within the normal resection lines
timeFrame: week 1
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: Professor at University Hospital Køge
name: Ismail Gögenur, Professor
role: PRINCIPAL_INVESTIGATOR
References: