Ricerc@Sapienza

Background:

Gastric cancer is a worldwide challenge due to its spread, even epidemic in some areas, and the high mortality rates.

Lymphadenectomy is considered the fundamental step during radical gastrectomy for gastric cancer.

In recent years, some researchers have tried to find a way to improve the surgical identification of the lymphatic drainage routes and lymph node stations. This new surgical frontier is the so called "navigation surgery".

Among the different reported solutions, lately, the indocyanine green (ICG) has drawn attention. It is a fluorescence dye, that can be detected in the near infrared spectral band (NIR). The development of specific fluorescence imaging devices has allowed surgeons to visualize tumors, vascular and lymphatic structures.

Some advantages of the ICG are: reduced toxicity, absence of radioactivity, low cost, safe administration both intravenous and endoscopical through the submucosa or subserosa, protein binding without changing molecular structures, and macrophages interaction at the lymph node level.

This imaging technology has been used in colo-rectal and hepato-biliary surgery. However, up to date, the use of fluorescence imaging technology has not been extensively evaluated during lymphadenectomy for both early and advanced gastric cancer.

Methods:

General design: to evaluate the role of fluorescence imaging during lymphadenectomy for gastric cancer.

Type of study: interventional observational pilot study.

Duration: 12 months.

Inclusion criteria: positive biopsy, curative intent.

Experimental group: patients undergoing dissection assisted by ICG.

Control group: patients undergoing the same surgery without the injection of ICG.

Primary outcomes: Fluorescent lymph nodes (FLNs) identification rate, accuracy of the procedure, comparison with the control group on the total number of lymph nodes retrieved. Sample size: 20 patients in the experimental group, 20 patients in the control group.