Using ICG imaging technology during surgery for 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
This study is testing if a special imaging technology can help surgeons perform better during operations for patients with advanced stomach cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Niguarda Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Milan, Italia) |
| Trial ID | NCT04943484 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed advanced gastric adenocarcinoma eligible for gastrectomy.
Not a fit: Patients with distant metastasis or those who have had previous upper abdominal surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical outcomes and improve the accuracy of cancer resections in patients with advanced gastric cancer.
How similar studies have performed: While the clinical value of NIR/ICG technology in this context is not fully established, similar imaging techniques have shown promise in other surgical oncology fields.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milan, Italia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.