ICG (Indocyanine Green) Imaging Fluorescence Technology in Surgical Treatment of Advanced Gastric Cancer
ConditionGastric Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNiguarda Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- imaging fluorescence NIR/ICG
Treatment groups
360 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov