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NCT04943484Recruiting

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

Source: ClinicalTrials.gov · Last updated 16 Apr 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Observational
Enrollment
360 (estimated)
First submitted
21 Jun 2021
Start date
1 Jan 2022
Primary completion date
31 Aug 2024
Lead sponsor
Niguarda Hospital
NCT number
NCT04943484

What you commit to

  • Study type: Observational
  • Planned participants: 360
  • From 1 Jan 2022 to the primary completion date, 31 Aug 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of previous upper abdominal surgery (laparoscopic cholecystectomy will be allowed)
  • History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
  • History of previous neoadjuvant chemotherapy (except perioperative chemotherapy for gastric cancer) or radiotherapy

Other illness

  • History of allergy to iodine agents
  • Cancer located at the esophago-gastric junction (Siewert I, II, III tumors 29)

Other

  • Women during pregnancy or breast-feeding
  • Patients candidates to transthoracic esophagectomy, transhiatal extended gastrectomy or proximal gastrectomy

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
ASST GOM Niguarda
Coordinator of this site? Confirm its status
MilanItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.