[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617636":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":57,"collaborators":59,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":25,"enrollmentInfo":78,"targetDuration":25,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Tianjin Medical University Second Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Template Lymph Node Dissection","EXPERIMENTAL","Patients randomized to this arm will undergo radical nephrectomy (which may be performed via open, laparoscopic, or robot-assisted approach based on the surgeon's expertise) combined with a standardized template lymph node dissection.\n\nThe template lymph node dissection is defined as follows:\n\nFor Left-sided Tumors: Removal of lymphatic tissue anterior and lateral to the abdominal aorta, extending from the diaphragmatic crus superiorly to the aortic bifurcation inferiorly, including the renal hilar lymph tissue.\n\nFor Right-sided Tumors: Removal of lymphatic tissue surrounding the inferior vena cava and in the interaortocaval space, extending from the liver edge of the vena cava superiorly to the iliac vein bifurcation inferiorly, including the renal hilar lymph tissue.",[13],"Procedure: Template Lymph Node Dissection",{"label":15,"type":16,"description":17,"interventionNames":18},"Selective Lymph Node Resection","ACTIVE_COMPARATOR","Patients randomized to this arm will undergo radical nephrectomy (which may be performed via open, laparoscopic, or robot-assisted approach). In this arm, only lymph nodes that are identified as \\>1 cm in the short axis on preoperative cross-sectional imaging (CT\u002FMRI) OR are grossly enlarged and suspicious during the surgeon's intraoperative assessment will be resected. If no such nodes are identified preoperatively or intraoperatively, no formal lymph node dissection is performed.",[19],"Procedure: Selective Lymph Node Resection",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","A standardized surgical procedure to remove lymph nodes within defined anatomical boundaries during radical nephrectomy for kidney cancer. For left-sided tumors, this includes tissue anterior and lateral to the aorta from the diaphragmatic crus to the aortic bifurcation. For right-sided tumors, it includes tissue around the vena cava and between the vena cava and aorta from the liver edge to the iliac bifurcation. The renal hilar lymph tissue is always included.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"A surgical approach during radical nephrectomy for kidney cancer where lymph nodes are removed only if they meet specific criteria: being larger than 1 cm on preoperative CT\u002FMRI scans, or appearing grossly enlarged and suspicious to the surgeon during the operation. If no such nodes are identified, no lymph node dissection is performed.",[15],[30],{"name":31,"affiliation":5,"role":32},"Changyi Quan, MD","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Shimiao Zhu, MD, PhD","CONTACT","+86 88328607","zhushimiao@tmu.edu.cn",[40],{"facility":5,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Tianjin","Tianjin Municipality","300211","China","CN",{"type":48,"coordinates":49},"Point",[50,51],117.17667,39.14222,{"lat":51,"lon":50},[54],{"name":55,"role":36,"phone":56,"phoneExt":25,"email":25},"Changyi Quan","+86 22 88328607",{"type":58,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[60,62,64,66],{"name":61,"class":6},"Sun Yat-Sen University Cancer Center",{"name":63,"class":6},"Tianjin Medical University Cancer Institute and Hospital",{"name":65,"class":6},"Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center",{"name":67,"class":6},"Tianjin Third Central Hospital","100617636","radical-nephrectomy-with-vs-without-template-lymph-node-dissection-in-high-risk-renal-cell-carcinoma-t-lnd-rcc-100617636",false,"NCT07321197","Radical Nephrectomy With vs Without Template Lymph Node Dissection in High-Risk Renal Cell Carcinoma (T-LND RCC)","Template Lymph Node Dissection for Tumor Control in High-Risk Renal Cell Carcinoma: A Prospective, Open-Label, Multicenter, Randomized Controlled Trial","RECLND","Inclusion Criteria:\n\n* Signed informed consent form.\n* Age \\> 18 years.\n* Candidate for radical nephrectomy with or without lymph node dissection.\n* High-risk renal cell carcinoma defined as: At least ONE of: Clinical stage cT3-4 N0-1 M0 (AJCC 8th ed); OR radiologically visible lymph node \\>1cm; OR M1 disease rendered no evidence of disease (NED) after local therapy; OR radiologically determined rT4 stage. OR at least TWO of: Renal vein or inferior vena cava tumor thrombus; OR nuclear grade 3-4 or sarcomatoid differentiation or coagulative necrosis; OR tumor size \\>= 10cm; OR hematuria and\u002For local symptoms.\n* Measurable disease as per RECIST v1.1.\n* ECOG performance status of 0 or 1.\n* Adequate bone marrow, renal, and hepatic function.\n* For women and men of childbearing potential, agreement to use effective contraception during the study period.\n\nExclusion Criteria:\n\n* Prior radiotherapy, chemotherapy, major surgery, or targeted therapy for RCC.\n* Concurrent other active malignancy (except controlled malignancies not affecting 2-year survival).\n* Candidate for partial nephrectomy or ablation per multidisciplinary team assessment.\n* Preoperative imaging indicates unresectable regional lymph nodes.\n* renal tumors or known hereditary RCC syndrome.\n* Diagnosis of any other active malignancy within the past 5 years.\n* Active autoimmune disease or history of autoimmune disease.\n* Use of immunosuppressive agents within 2 weeks prior to enrollment.\n* Poorly controlled cardiac or clinical symptoms.\n* Coagulopathy or bleeding tendency.\n* Active gastrointestinal conditions with risk of bleeding or perforation.\n* History of significant bleeding or thromboembolic events within specified timeframes.\n* Active infection or unexplained fever \\>38.5°C.\n* Abdominal fistula, gastrointestinal perforation, or abscess within 4 weeks prior.\n* History of pulmonary fibrosis, interstitial lung disease, or severely impaired pulmonary function.\n* Known immunodeficiency or active hepatitis.\n* Participation in another clinical trial within 1 month.\n* Known history of drug abuse or alcohol addiction.\n* Inability or unwillingness to bear the self-paid portion of examination and treatment costs.\n* Any condition that, in the investigator's judgment, may compromise patient safety or study conduct.","ALL","18 Years",{"count":79,"type":80},220,"ESTIMATED","INTERVENTIONAL",[83],"NA","The goal of this clinical trial is to learn if a more thorough lymph node removal surgery, called \"Template Lymph Node Dissection,\" can help prevent cancer from returning and help patients live longer, compared to removing only a few enlarged lymph nodes, in patients with high-risk kidney cancer. The main questions it aims to answer are:\n\nDo patients who receive template lymph node dissection live longer without their cancer returning (Disease-Free Survival)? Do patients who receive template lymph node dissection live longer overall (Overall Survival)? Is the more extensive lymph node surgery as safe as the limited surgery? Researchers will compare the Template Lymph Node Dissection group to the Limited Node Resection group to see the effects on cancer control and safety.\n\nParticipants will:\n\nBe randomly assigned to one of the two surgical groups. Undergo surgery to remove their kidney and the assigned lymph nodes. Attend regular follow-up visits with imaging scans (like CT or MRI) for the first 5 years after surgery to monitor if the cancer returns.\n\nBe followed for their overall survival status for up to 10 years.",[86],"Renal Cell Carcinoma (Kidney Cancer)",[9,88,89,90],"High-Risk Neoplasm","Randomized Controlled Trial","Surgical Oncology","2026-06-22",{"date":93,"type":94},"2026-06-25","ACTUAL",{"date":96,"type":94},"2025-09-01",{"date":98,"type":80},"2033-09-30",{"name":5,"class":6},1]