ICG (Indocyanine Green) Imaging Fluorescence Technology in Surgical Treatment of Advanced Gastric… (NCT04943484) | Clinical Trial Compass
RecruitingNot Applicable
ICG (Indocyanine Green) Imaging Fluorescence Technology in Surgical Treatment of Advanced Gastric Cancer
Italy360 participantsStarted 2022-01-01
Plain-language 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
Who can participate
Age range18 Years
SexALL
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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