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Radical Nephrectomy With vs Without Template Lymph Node Dissection in High-Risk Renal Cell Carcinoma (T-LND RCC): A Randomized Clinical Trial
Sponsor: Tianjin Medical University Second Hospital
Summary
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: Do 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. Participants will: Be 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. Be followed for their overall survival status for up to 10 years.
Official title: Template Lymph Node Dissection for Tumor Control in High-Risk Renal Cell Carcinoma: A Prospective, Open-Label, Multicenter, Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2026-01-01
Completion Date
2033-09-30
Last Updated
2026-01-06
Healthy Volunteers
No
Conditions
Interventions
Template Lymph Node Dissection
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.
Selective Lymph Node Resection
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/MRI 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.