[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100528471":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":34,"locations":44,"responsibleParty":64,"collaborators":28,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":9,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":28,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":46,"whyStopped":28,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Fujian Medical University","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"3D-4K-ICG","EXPERIMENTAL","Indocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection",[13],"Procedure: Indocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection",{"label":15,"type":10,"description":16,"interventionNames":17},"4K-ICG","Indocyanine Green Tracer Using in Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"3D","PLACEBO_COMPARATOR","3D Laparoscopic Gastrectomy with Lymph Node Dissection",[13],[24],{"type":25,"name":11,"description":26,"armGroupLabels":27,"otherNames":28},"PROCEDURE","Indocyanine green tracer is used with 3D plus ultra high resolution laparoscopic gastrectomy with lymph node Dissection for gastric cancer",[19,9,15],null,[30],{"name":31,"affiliation":32,"role":33},"Chang-ming Huang","Fujian Medical University Union Hospital","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":28,"email":39},"Mi Lin","CONTACT","13459152658","silihuala@qq.com",{"name":41,"role":37,"phone":42,"phoneExt":28,"email":43},"Hua-Long Zheng","18359190587","291167038@qq.com",[45],{"facility":32,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Fuzhou","Fujian","350001","China","CN",{"type":53,"coordinates":54},"Point",[55,56],119.30611,26.06139,{"lat":56,"lon":55},[59,63],{"name":60,"role":37,"phone":61,"phoneExt":28,"email":62},"Changming Huang, MD","+86-133-6591-0253","hcmlr2002@163.com",{"name":60,"role":33,"phone":28,"phoneExt":28,"email":28},{"type":33,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":32,"oldNameTitle":28,"oldOrganization":28},"Chang-Ming Huang, Prof.","Professor","100528471","phase-3-3d-4k-icg-laparoscopic-gastrectomy-for-gastric-cancer-100528471",false,"NCT06161207","3D-4K-ICG Laparoscopic Gastrectomy for Gastric Cancer","Prospective Randomized Controlled Trials on Clinical Outcomes of Indocyanine Green Tracer Using in 3D Plus Ultra High Resolution Laparoscopic Gastrectomy With Lymph Node Dissection for Locally Advanced Gastric Cancer","Inclusion Criteria:\n\n1. Age from 18 to 75 years\n2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy\n3. cT2-4a, N-\u002F+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition\n4. No distant metastasis, no direct invasion of pancreas, spleen or other adjacent organs in the preoperative examinations\n5. Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale\n6. ASA (American Society of Anesthesiology) class I to III\n7. Written informed consent\n\nExclusion Criteria:\n\n1. Women during pregnancy or breast-feeding\n2. Severe mental disorder\n3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)\n4. History of previous gastric surgery (including ESD\u002FEMR for gastric cancer)\n5. Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging\n6. Other malignant disease within the past 5 years\n7. History of previous neoadjuvant chemotherapy or radiotherapy\n8. History of unstable angina or myocardial infarction within past six months\n9. History of cerebrovascular accident within past six months\n10. History of continuous systematic administration of corticosteroids within one month\n11. Requirement for simultaneous surgery for other disease\n12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer\n13. FEV1 (forced expiratory volume in one second)\\\u003C50% of predicted values\n14. Diffuse invasive gastric cancer\n15. History of an iodine allergy\n16. Patients who declined laparoscopic surgery","ALL","18 Years","75 Years",{"count":78,"type":79},702,"ESTIMATED","INTERVENTIONAL",[82],"PHASE3","Patients with locally advanced gastric adenocarcinoma (CT2-4a N-\u002F+ M0) were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection for gastric cancer.",[85,86],"Gastric Cancer","Surgery",[88,89,85,90,19],"Indocyanine Green Tracer","Laparoscopic Gastrectomy","Ultra High Resolution","2024-06-20",{"date":93,"type":94},"2024-06-24","ACTUAL",{"date":96,"type":94},"2023-01-03",{"date":98,"type":79},"2029-01-01",{"name":5,"class":6},1]