Actively Recruiting

Age: 18Years +
All Genders
NCT04943484

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

Led by Niguarda Hospital · Updated on 2026-04-16

360

Participants Needed

1

Research Sites

256 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

ASST GOM Niguarda

Milan, Italia, Italy, 20162

Actively Recruiting

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Research Team

P

Pietro M Lombardi, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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