Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma
Start Date
5/17/2024
Completion Date
1/1/2029
Summary
The goal of this study is to conduct the first randomized-controlled trial to determine the oncologic efficacy of lymph node dissection in participants with upper tract urothelial cell carcinoma. The main questions it aims to answer are: * To determine oncologic outcomes, specifically 2-year recurrence-free survival * To determine other oncologic outcomes including treatment-free, cancer-specific and overall survival * To determine time to recurrence and recurrence patterns * To determine use of adjuvant therapies * To determine perioperative complications Participants will undergo nephroureterectomy with or without lymph node dissection. Researchers will compare these two groups to determine the oncologic efficacy of performing lymph node dissection.
Detailed Description
Upper Tract Urothelial Carcinoma (UTUC) is a rare disease with complex management. Some participants with clinically negative nodes may still receive a lymph node dissection (LND) with nephroureterectomy, and currently, no randomized controlled trial exists to evaluate the oncologic efficacy of this practice. According to current American Urologic Association guidelines, Nephroureterectomy is the standard of care intervention for high-risk UTUC and low-risk UTUC is endoscopically unresectable. The aim of the present study is to determine the efficacy, specifically 2-year recurrence-free survival, of lymph node dissection at time of nephroureterectomy for participants with UTUC, compared to no lymph node dissection, as well as examine other oncologic outcomes and complication rates
Eligibility Criteria
Age Range: 19 years to No maximum
Interventions
Nephroureterectomy
Lymph Node Dissection
Conditions
Locations
University of Florida Health Science Center
Gainesville, Florida 32209
United States
Southern Illinois University
Springfield, Illinois 62702
United States
University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center
Cleveland, Ohio 44106
United States
Cleveland Clinic Glickman Urological and Kidney Institute
Cleveland, Ohio 44195
United States