RecruitingNot ApplicableNCT07321210

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

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

Sponsor

Tianjin Medical University Second Hospital

Enrollment

150 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Lymph Node Dissection Upper Tract Urothelial Carcinoma

Summary

The goal of this clinical trial is to learn if adding a template lymph node dissection (TLND) to the standard surgery for upper tract urothelial cancer (UTUC) can improve patient survival and prevent the cancer from recurrence. The main questions it aims to answer are: Do patients who receive standard surgery with LND live longer without their cancer returning? Is adding LND safe, and how does it affect surgery-related complications? Researchers will compare the group receiving standard surgery plus LND to the group receiving standard surgery alone to see if adding LND is more effective. Participants will: Be randomly assigned to one of the two surgical groups. Undergo their assigned surgery and recover in the hospital. Attend regular follow-up visits for checkups and scans for 5 years to monitor for cancer recurrence, with the possibility of long-term follow-up extending to 10 years.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Selective Lymph Node Resection and a procedure called Template Lymph Node Dissection for people with lymph node dissection and upper tract urothelial carcinoma. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETemplate Lymph Node Dissection

A systematic and anatomic-based lymph node dissection performed during radical nephroureterectomy (RNU) for upper tract urothelial carcinoma (UTUC). The dissection boundaries are strictly defined by a pre-specified template according to the primary tumor location: renal hilum+para-aortic (left hilar and paraaortic) or renal hilum+para-caval (right hilar, paracaval, and interaortocaval) for renal pelvis/upper ureter; extended to common/external iliac for mid-ureter; and pelvic (common, external, internal iliac, and obturator) for lower ureter. The goal is potential therapeutic benefit by removing nodal metastatic disease.

PROCEDURESelective Lymph Node Resection

A diagnostic procedure performed during radical nephroureterectomy (RNU). It does not involve a systematic template dissection. The surgeon will only remove intraoperatively identified suspicious and radiographic lymphadenopathy (\>1 cm in the short-axis diameter). The primary goal is pathological staging rather than therapeutic clearance of a nodal basin.