Fluorescence image-guided lymphadenectomy using indocyanine green and near infrared technology during robotic gastrectomy: a prospective pilot study: IG-MIG Study

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. In recent years, some researchers have tried to find a way to improve the surgical identifi cation of the lymphatic drainage routes and lymph node stations. This new surgical frontier is the so called “navigation surgery”. Among the diff erent 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. The Da Vinci Xi robotic system has an integrated imaging technology that has been used in colo-rectal and hepatobiliary surgery. However, up to date, the combined use of fluorescence imaging and robotic technology has not been evaluated during lymphadenectomy in gastric cancer. Methods: General design: to evaluate the role of fluorescence imaging during robotic lymphadenectomy for gastric cancer. Type of study: interventional prospective pilot study. Duration: 18 months. 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. Ethics: This study is conducted in compliance with ethical principles originating from the Helsinki Declaration, within the guidelines of Good Clinical Practice and relevant laws/regulations. Trial registration number: NCT03931044