[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574151":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":60,"collaborators":20,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":20,"enrollmentInfo":73,"targetDuration":20,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":85,"overallStatus":53,"whyStopped":20,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Ukrainian Society of Clinical Oncology","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Indocyanine green mapping","EXPERIMENTAL","Endoscopic injection of indocyanine green is performed under general anesthesia.\n\nIndocyanine green is injected into the submucosal layer of the stomach at 4 points around the tumor. The dosage for one administration is up to 5 mg. The total dosage for one patient for 4 doses is 20 mg. Monitoring of indocyanine green side effects occurs before the start of general anesthesia during radical surgery.",[13],"Drug: Endoscopic injection of Indocyanine green",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Endoscopic injection of Indocyanine green","ICG is injected by the patient by endoscopic submucosal injection into 4 points around the tumor 24-12 hours before the start of the surgical intervention.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Oleksii Dobrzhanskyi, MD","CONTACT","+380638760185","oleksii.dobrzhanskyi@unci.org.ua",[28,52],{"facility":29,"status":30,"city":31,"state":20,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"National Cancer Institute","NOT_YET_RECRUITING","Kyiv","03022","Ukraine","UA",{"type":36,"coordinates":37},"Point",[38,39],30.5238,50.45466,{"lat":39,"lon":38},[42,43,45,48,50],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"name":23,"role":44,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"name":46,"role":47,"phone":20,"phoneExt":20,"email":20},"Yurii Kondratskyi, MD, PhD","SUB_INVESTIGATOR",{"name":49,"role":47,"phone":20,"phoneExt":20,"email":20},"Andrii Horodetskyi, MD",{"name":51,"role":47,"phone":20,"phoneExt":20,"email":20},"Mykyta Pepenin, MD",{"facility":29,"status":53,"city":31,"state":20,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":54,"geoPoint":56,"contacts":57},"RECRUITING",{"type":36,"coordinates":55},[38,39],{"lat":39,"lon":38},[58],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":59},"alekseydobrzhanskiy@gmail.com",{"type":44,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Oleksii Dobrzhanskiy","Doctor","100574151","phase-3-investigation-of-impact-of-indocyanine-green-on-volume-of-lymphadenectomy-in-resectable-gastric-cancer-100574151",false,"NCT06755554","Investigation of Impact of Indocyanine Green on Volume of Lymphadenectomy in Resectable Gastric Cancer","Investigation of Effect of Indocyanine Green on Volume of Lymph Node Dissection in Surgical Treatment of Gastric Cancer","ICGastr","Inclusion Criteria:\n\n* Tumor spread: cT2-4a cN0-3,\n* cM0;\n* Age: 18 - 80;\n* Gender: men and women;\n* ECOG: 0 - 1;\n* Histologic type of tumor: Adenocarcinoma of any subtype;\n* Degree of differentiation: G1 - G4;\n* Tumor localization: cardiac region, stomach floor, stomach body, antrum, pylorus, and pyloric region of the stomach;\n* Tumor spread: absence of tumor invasion into adjacent structures;\n* No history of cancer in the last 5 years;\n* No previous chemotherapy, surgery or radiation treatment for another cancer (except for neoadjuvant chemotherapy for gastric cancer);\n* Absence of severe comorbidity restricting laparoscopic approach.\n\nExclusion Criteria:\n\n* M1 (distant metastases);\n* ECOG 2 - 4;\n* Age over 80 and under 18;\n* Presence of severe comorbidities, ASA\\> 3;\n* Patient refusal to participate in the study.","ALL","18 Years",{"count":74,"type":75},105,"ESTIMATED","INTERVENTIONAL",[78],"PHASE3","The study aims to evaluate the safety and benefits of using indocyanine green in lymph node dissection for gastric cancer surgery. The primary endpoint is the average number of lymph nodes removed. Secondary study points are the average number of ICG-positive lymph nodes; the average number of metastatic ICG-positive lymph nodes; the number of postoperative complications and complications associated with the administration of ICG.\n\nPatients who meet the inclusion criteria for this study will be enrolled in the study after reviewing and signing an informed consent form.\n\nAll patients will be included in one group and will receive surgical treatment in the amount of total or subtotal gastrectomy with lymphadenectomy D1, D1+, D2 or D2+.\n\nICG is injected by the patient by endoscopic submucosal injection into 4 points around the tumor 24-12 hours before the start of the surgical intervention.\n\nAssessment of the number of fluorescent lymph nodes will be performed intraoperatively with their subsequent removal and mapping. The incidence of postoperative complications will be assessed by Clavien-Dindo.",[81,82,83,84],"Gastric Cancer Stage II","Gastric Cancer Stage III","Gastric Cancer","Gastrectomy for Gastric Cancer",[86,87,88],"indocyanine green","gastric cancer","gastrectomy","2025-03-25",{"date":91,"type":92},"2025-03-30","ACTUAL",{"date":94,"type":92},"2025-01-01",{"date":96,"type":75},"2026-02-01",{"name":5,"class":6},2]