[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100434921":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":24,"studyPopulation":25,"armGroups":26,"interventions":31,"overallOfficials":39,"centralContacts":44,"locations":50,"responsibleParty":68,"collaborators":20,"id":70,"slug":20,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":20,"enrollmentInfo":79,"targetDuration":20,"studyType":82,"phases":20,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":53,"whyStopped":20,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Niguarda Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Surgical conduct","Incidence of \"change of the surgical conduct\" (CSC) at the moment of intraoperative NIR\u002FICG technology activation after a D2 lymphadenectomy performed \"with the naked eye\"","During surgical intervention (hours)",[14,17],{"measure":15,"description":16,"timeFrame":12},"Nodal fluorescence distribution","Pattern of nodal fluorescence distribution according to tumor and patient characteristics",{"measure":18,"description":19,"timeFrame":12},"Clinical variables associated with change of the surgical conduct","Identification of preoperative clinical variables potentially associated with change of the surgical conduct",null,{"allocation":20,"interventionModel":20,"interventionModelDescription":20,"primaryPurpose":20,"observationalModel":22,"timePerspective":23,"maskingInfo":20},"COHORT","PROSPECTIVE","Near infra-red\u002F indocyanine green imaging fluorescence (NIR\u002FICG) technology is showing promising results in several fields of surgical oncology.\n\nThe clinical value of NIR\u002FICG (near infrared range\u002Findocyanine green) technology in surgical treatment of advanced gastric cancer (AGC) is not clearly established and data regarding whether its application is associated with a change of the intraoperative surgical conduct are lacking in literature.\n\nThis is the \"iGreenGO (indocyanine Green Gastric Observation) Study\" protocol: an international, prospective, multicentre, study.\n\nStudy population will be a cohort of western patients who will undergo preoperative upper gastrointestinal endoscopy at the most 20 hours before surgery (intraoperative endoscopic injection before starting surgical dissection is also allowed) with submucosal peritumoral ICG injection and curative-intent gastrectomy with D2 lymphadenectomy for locally AGC.\n\nThe primary endpoint will be the incidence of \"change of the surgical conduct\" (CSC) at the moment of intraoperative NIR\u002FICG technology activation after a D2 lymphadenectomy performed \"with the naked eye\". Secondary endpoints will be the preoperative clinical variables potentially associated with CSC, the pattern of abdominal fluorescence distribution according to tumor and patient characteristics, the number of additional lymph nodes retrieved using NIR\u002FICG technology, the incidence of stage migration due to NIR\u002FICG application, 90-day morbidity and mortality The iGreenGO Study will be the first Western study to investigate the clinical role of NIR\u002FICG technology for surgical treatment of AGC in a large cohort of western patients. Results from the present study could provide novel information about which help NIR\u002FICG technology can supply to surgeons during lymphadenectomy for AGC and the patterns of ICG abdominal fluorescence distribution according to tumor and patient characteristics, which are unanswered questions at present time.","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",[27],{"label":28,"type":20,"description":25,"interventionNames":29},"Gastric cancer",[30],"Procedure: imaging fluorescence NIR\u002FICG",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"PROCEDURE","imaging fluorescence NIR\u002FICG","Preoperative upper GI endoscopy (UGE) UGE with submucosal injection of 2ml of ICG 0.125mg\u002Fml 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\u002FICG technology, \"change of surgical conduct\" (CSC) A visualization of the operative field (OF) with NIR\u002FICG technology is performed at the beginning of surgery and before to dissect each LNS. Subsequently, surgery is performed \"with the naked eye\".\n\nAt the end, a visualization of the OF is performed using NIR\u002FICG 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.",[28],[38],"indocyanine green",[40],{"name":41,"affiliation":42,"role":43},"Pietro M Lombardi, MD","Division of Minimally Invasive Surgical Oncology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda","PRINCIPAL_INVESTIGATOR",[45],{"name":41,"role":46,"phone":47,"phoneExt":48,"email":49},"CONTACT","+39026444","4570","pietrom.lombardi@gmail.com",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"ASST GOM Niguarda","RECRUITING","Milan","Italia","20162","Italy","IT",{"type":60,"coordinates":61},"Point",[62,63],12.59836,42.78235,{"lat":63,"lon":62},[66],{"name":41,"role":46,"phone":67,"phoneExt":48,"email":49},"0039026444",{"type":69,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100434921",false,"NCT04943484","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\u002FICG) Technology as a Modifier of Surgeon's Conduct During Curative Treatment of Advanced Gastric Cancer. Study Protocol for a Western, Observational, Prospective, Multicentric Study","iGreenGO","Inclusion criteria\n\n* Age ≥ 18 years old\n* Preoperative histologically proven adenocarcinoma of the upper, middle or lower part of the stomach.\n* 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\n* No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative and intraoperative examinations\n* Written informed consent\n\nExclusion criteria\n\n* Women during pregnancy or breast-feeding\n* History of previous upper abdominal surgery (laparoscopic cholecystectomy will be allowed)\n* History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection\n* History of allergy to iodine agents\n* Cancer located at the esophago-gastric junction (Siewert I, II, III tumors 29)\n* Patients candidates to transthoracic esophagectomy, transhiatal extended gastrectomy or proximal gastrectomy\n* History of previous neoadjuvant chemotherapy (except perioperative chemotherapy for gastric cancer) or radiotherapy","ALL","18 Years",{"count":80,"type":81},360,"ESTIMATED","OBSERVATIONAL","The iGreenGO Study aims to investigate whether the intraoperative application of NIR\u002FICG 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",[85],"Gastric Cancer",[87,88,38,89,90,91,92],"advanced","gastric cancer","ICG","surgery","D2 lymphadenectomy","surgical conduct","2026-04-13",{"date":95,"type":96},"2026-04-16","ACTUAL",{"date":98,"type":96},"2022-01-01",{"date":100,"type":81},"2026-11-30",{"name":5,"class":6},1]