Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imaging fluorescence NIR/ICG | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Gastric cancer
- description
- Male and female subjects, over 18 years of age, with histological diagnosis of locally advanced gastric carcinoma (AGC), surgically resectable, without evidence of distant metastases (cT2-T4a; N0-3; M0) for which a surgical intervention with curative purposes is indicated both as a first treatment and following preoperative neoadjuvant chemotherapy
- interventionNames
- Procedure: imaging fluorescence NIR/ICG
Primary outcomes (1)
- measure
- Surgical conduct
- timeFrame
- During surgical intervention (hours)
- description
- Incidence of "change of the surgical conduct" (CSC) at the moment of intraoperative NIR/ICG technology activation after a D2 lymphadenectomy performed "with the naked eye"
Secondary outcomes (2)
- measure
- Nodal fluorescence distribution
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available