Comparing Radical Nephroureterectomy With and Without Template Lymph Node Dissection in High-Risk Upper Tract Urothelial Carcinoma to Improve Survival and Safety

What this Trial Is About

Researchers are investigating whether adding a template lymph node dissection TLND to the standard radical nephroureterectomy RNU surgery improves survival and reduces cancer recurrence in patients with high-risk upper tract urothelial carcinoma UTUC. This multicenter, prospective, randomized trial aims to compare standard surgery with and without TLND, focusing on disease-free survival, overall survival, and safety outcomes including surgery-related complications. Participants will be randomly assigned to two groups one receiving RNU plus template LND performed according to specific anatomical templates based on tumor location, and the other receiving RNU with selective removal of only suspicious lymph nodes larger than 1 cm. Surgical approaches may vary open, laparoscopic, or robotic. Patients will be followed for up to 10 years to monitor outcomes. During the study, participants will undergo their assigned surgery and recover in the hospital. Follow-up visits will include regular imaging, urine cytology, and cystoscopy to monitor for cancer recurrence, with assessments occurring every few months for the first five years and possible extended observation. Researchers will measure survival rates, recurrence, operative safety, lymph node metastasis mapping, and biomarker analyses to evaluate treatment impact and safety over time.

Radical Nephroureterectomy With vs Without Template Lymph Node Dissection in High-Risk Upper Tract Urothelial Carcinoma (T-LND UTUC)