RECRUITINGOBSERVATIONAL

ICG (Indocyanine Green) Imaging Fluorescence Technology in Surgical Treatment of Advanced Gastric Cancer

[The iGreenGO Study]. Investigation About the Clinical Value of Indocyanine Green Imaging Fluorescence (NIR/ICG) Technology as a Modifier of Surgeon's Conduct During Curative Treatment of Advanced Gastric Cancer. Study Protocol for a Western, Observational, Prospective, Multicentric Study

About This Trial

The iGreenGO Study aims to investigate whether the intraoperative application of NIR/ICG technology is associated with a change in the surgical conduct (CSC) during curative-intent gastrectomy with D2 lymphadenectomy in a cohort of Western patients affected by AGC. The preoperative clinical variables potentially associated with CSC will be also investigated

Who May Be Eligible (Plain English)

Inclusion criteria - Age ≥ 18 years old - Preoperative histologically proven adenocarcinoma of the upper, middle or lower part of the stomach. - Advanced disease (Staged cT2-T4a, N0-3;M0 according to 8th edition of the AJCC TNM Staging System) at diagnosis, in which resection can be safely achieved by distal or total gastrectomy with D2 lymphadenectomy via a minimally invasive (laparoscopic or robotic) approach, either as first treatment or after neoadjuvant treatment - No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative and intraoperative examinations - Written willing to sign a consent form Exclusion criteria - Women during pregnancy or breast-feeding - History of previous upper abdominal surgery (laparoscopic cholecystectomy will be allowed) - History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection - History of allergy to iodine agents - Cancer located at the esophago-gastric junction (Siewert I, II, III tumors 29) - Patients candidates to transthoracic esophagectomy, transhiatal extended gastrectomy or proximal gastrectomy - History of previous neoadjuvant chemotherapy (except perioperative chemotherapy for gastric cancer) or radiotherapy Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion criteria * Age ≥ 18 years old * Preoperative histologically proven adenocarcinoma of the upper, middle or lower part of the stomach. * Advanced disease (Staged cT2-T4a, N0-3;M0 according to 8th edition of the AJCC TNM Staging System) at diagnosis, in which resection can be safely achieved by distal or total gastrectomy with D2 lymphadenectomy via a minimally invasive (laparoscopic or robotic) approach, either as first treatment or after neoadjuvant treatment * No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative and intraoperative examinations * Written informed consent Exclusion criteria * Women during pregnancy or breast-feeding * History of previous upper abdominal surgery (laparoscopic cholecystectomy will be allowed) * History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection * History of allergy to iodine agents * Cancer located at the esophago-gastric junction (Siewert I, II, III tumors 29) * Patients candidates to transthoracic esophagectomy, transhiatal extended gastrectomy or proximal gastrectomy * History of previous neoadjuvant chemotherapy (except perioperative chemotherapy for gastric cancer) or radiotherapy

Treatments Being Tested

PROCEDURE

imaging fluorescence NIR/ICG

Preoperative upper GI endoscopy (UGE) UGE with submucosal injection of 2ml of ICG 0.125mg/ml solution to four peritumoral sites 15-20 hours before surgery Surgery D2 Distal gastrectomy with dissection of 1, 3, 4sb, 4sd, 5, 6, 7, 8a, 9, 11p, 12a lymph node stations (LNS) D2 Total gastrectomy with dissection of 1, 2, 3, 4sa, 4sb, 4d, 5, 6, 7, 8a, 9, 11p, 11d, 12a LNS Intraoperative NIR/ICG technology, "change of surgical conduct" (CSC) A visualization of the operative field (OF) with NIR/ICG technology is performed at the beginning of surgery and before to dissect each LNS. Subsequently, surgery is performed "with the naked eye". At the end, a visualization of the OF is performed using NIR/ICG technology to verify whether residual lymph nodes in each D2 nodal station exist. CSC is defined as the occurring of the following situation: in case of persistence of nodal fluorescence in D2 nodal stations, the completion of the dissection of the residual nodal fluorescent structures.

Locations (1)

ASST GOM Niguarda

Milan, Italia, Italy