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

Colon Cancer Clinical Trial

— SENSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02167087
• Other study ID #: SENSE2014
• Status: Completed
• Phase: N/A
• First received: June 6, 2014
• Last updated: February 15, 2016
• Start date: March 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colon Cancer
• Lymphatic Metastasis

Intervention

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.

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Ismail Gögenür

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of sentinel nodes identified during surgery and their localization		day 1	No
Secondary	Number of sentinel nodes identified by ex vivo sentinel node mapping		week 1	No
Secondary	Malignant status of the sentinel node(s)		week 1	No
Secondary	Malignant status of the lymph nodes		week 1	No
Secondary	Number of cases with negative sentinel node, but positive non-sentinel node		week 1	No
Secondary	Localization of sentinel nodes with metastasis		week 1	No
Secondary	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	No
Secondary	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	No
Secondary	Number of procedures where the procedure is stopped due to technical reasons		day 1	No
Secondary	Registration of possible side effects occurring due to the use of indocyanine green		day 1	Yes
Secondary	Number of sentinel nodes identified by only one of the sentinel node mapping techniques		week 1	No
Secondary	Total number of lymph nodes		week 1	No
Secondary	Localization of the identified sentinel nodes, and whether or not they are included within the normal resection lines		week 1	No