Using ICG imaging technology during surgery for advanced gastric cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The iGreenGO Study investigates the impact of near-infrared/indocyanine green (NIR/ICG) imaging technology on surgical procedures for patients with advanced gastric cancer. This observational study will involve a cohort of Western patients undergoing curative-intent gastrectomy with D2 lymphadenectomy, where ICG will be injected preoperatively to assess its effect on surgical conduct. The primary focus is to determine if the use of NIR/ICG leads to changes in surgical approach and to evaluate various clinical variables associated with these changes. Secondary endpoints include the number of lymph nodes retrieved and the incidence of complications post-surgery.

Why it matters

Who can join: the full rules

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

Where it's running

• ASST GOM Niguarda
  Milan, Italia, Italy Recruiting

Study contacts

• Principal investigator: Pietro M Lombardi, MD — Division of Minimally Invasive Surgical Oncology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda
• Study coordinator: Pietro M Lombardi, MD
• Email: pietrom.lombardi@gmail.com
• Phone: +39026444

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.