NCT02167087

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Ismail Gögenür · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colon Cancer
• Lymphatic Metastasis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2014-06-18
• Last updated: 2016-02-17

Locations

1 site across 1 country: Denmark