Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma

There is a high rate of intravesical (bladder) recurrence following extirpative surgery for upper tract urothelial carcinoma. There is no single established standard of care for prevention of intravesical recurrence; however, one protocol in common use involves the use of intravesical gemcitabine instilled into the bladder during surgery and prior to entry into the bladder. There are barriers to the use of gemcitabine, especially at lower volume centers. Some evidence suggests that intravesical irrigation with sterile water has equivalent efficacy to intravesical chemotherapy in prevention of recurrent bladder cancer following transurethral resection of bladder tumors (TURBT). This study is intended to compare recurrence rates using intravesical gemcitabine (as a pseudo-standard of care) and continuous bladder irrigation with sterile water.

NCT Number	NCT04865939
Lead Sponsor	University of Texas Southwestern Medical Center
Conditions	Urothelial Cancer of Renal Pelvis, Urothelial Carcinoma Ureter
Enrollment	132 participants
Start Date	2021-11-29
Primary Completion	2029-11-01 (estimated)
Study Completion	2031-11-01 (estimated)
Updated on ClinicalTrials.gov	2025-07-17