Clinical Efficacy and Safety of Radical Nephroureterectomy With Versus Without Template Lymph Node Dissection in High-Risk Upper Tract Urothelial Carcinoma: A Multicenter, Prospective, Randomized Controlled Clinical Trial

What this Trial Is About

Researchers are studying high-risk upper tract urothelial carcinoma (UTUC), a rare and aggressive cancer affecting the urinary system. The trial aims to determine whether adding a template lymph node dissection (TLND) to the standard surgery, radical nephroureterectomy (RNU), can improve survival and reduce cancer recurrence. This prospective, randomized trial compares standard surgery alone versus surgery plus TLND to evaluate disease-free and overall survival, safety, and surgical complications in patients with non-metastatic UTUC. Participants will be randomly assigned to one of two groups. One group will receive RNU combined with a systematic template lymph node dissection based on tumor location, while the other group will undergo RNU alone with selective removal of suspicious lymph nodes if detected. Surgery may be performed through open, laparoscopic, or robotic approaches according to surgeon preference. Follow-up includes regular imaging, urine cytology, and cystoscopy for up to 10 years to monitor for cancer recurrence and survival outcomes. During the study, participants will have hospital recovery after surgery and attend scheduled visits every three months for the first two years, then every six months up to five years, for assessments including scans and cystoscopy. Researchers will track outcomes such as disease-free survival, overall survival, recurrence-free survival, and surgery safety over 5 years, with potential long-term follow-up extending to 10 years. The trial also includes biomarker and imaging analyses to better understand lymph node involvement and prognosis.

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