RecruitingNCT04943484

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

Sponsor

Niguarda Hospital

Enrollment

360 participants

Start Date

Jan 1, 2022

Study Type

OBSERVATIONAL

Conditions

Gastric Cancer

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using a special fluorescent dye (indocyanine green, or ICG) combined with infrared imaging during surgery helps surgeons see tumors and lymph nodes more clearly when removing advanced stomach cancer. **You may be eligible if...** - You are 18 or older - You have been diagnosed with stomach (gastric) cancer confirmed by biopsy (adenocarcinoma type) - Your cancer is at an advanced local stage (T2-T4a, no distant spread) - Surgeons plan to perform a minimally invasive (laparoscopic or robotic) gastrectomy with full lymph node removal - You have not had prior upper abdominal surgery (laparoscopic gallbladder removal is acceptable) **You may NOT be eligible if...** - You are pregnant or breastfeeding - Your cancer has spread to distant organs - You have had previous extensive upper abdominal surgery - You have known allergy to ICG dye or iodine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREimaging 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.