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
This trial does not accept healthy volunteersQualifiers
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 population
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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
imaging fluorescence NIR/ICG
Procedure/SurgeryPreoperative upper GI endoscopy (UGE) UGE with submucosal injection of 2ml of ICG 0.125mg/ml solution to four peritumoral sites 15-20 hours before surgery Surgery D2 Distal gastrectomy with dissection of 1, 3, 4sb, 4sd, 5, 6, 7, 8a, 9, 11p, 12a lymph node stations (LNS) D2 Total gastrectomy with dissection of 1, 2, 3, 4sa, 4sb, 4d, 5, 6, 7, 8a, 9, 11p, 11d, 12a LNS Intraoperative NIR/ICG technology, "change of surgical conduct" (CSC) A visualization of the operative field (OF) with NIR/ICG technology is performed at the beginning of surgery and before to dissect each LNS. Subsequently, surgery is performed "with the naked eye". At the end, a visualization of the OF is performed using NIR/ICG technology to verify whether residual lymph nodes in each D2 nodal station exist. CSC is defined as the occurring of the following situation: in case of persistence of nodal fluorescence in D2 nodal stations, the completion of the dissection of the residual nodal fluorescent structures.
Treatment groups
360 Participants
are divided into 1 treatment groupGroup A: Gastric cancer1 intervention
Trial outcomes
Primary outcomes
1
Surgical conduct
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"
Time frame
During surgical intervention (hours)Secondary outcomes
1
Nodal fluorescence distribution
Pattern of nodal fluorescence distribution according to tumor and patient characteristics
Time frame
During surgical intervention (hours)2
Clinical variables associated with change of the surgical conduct
Identification of preoperative clinical variables potentially associated with change of the surgical conduct
Time frame
During surgical intervention (hours)Sponsors and contacts
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Source ClinicalTrials.gov