|

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

RECRUITINGSponsored by Niguarda Hospital
Actively Recruiting
SponsorNiguarda Hospital
Started2022-01-01
Est. completion2024-08-31
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerGastric Cancer

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.