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

RecruitingOBSERVATIONAL
Enrollment

360

Participants

Timeline

Start Date

January 1, 2022

Primary Completion Date

August 31, 2024

Study Completion Date

November 30, 2024

Conditions
Gastric Cancer
Interventions
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."

Trial Locations (1)

20162

RECRUITING

ASST GOM Niguarda, Milan

All Listed Sponsors
lead

Niguarda Hospital

OTHER