Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma
A Randomized Trial Comparing Intravesical Gemcitabine to Continuous Bladder Irrigation With Sterile Water to Prevent Bladder Cancer Implantation in Patients Undergoing Excision of Upper Tract Urothelial Carcinoma
University of Texas Southwestern Medical Center
132 participants
Nov 29, 2021
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
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Interventions
Continuous irrigation of bladder with sterile water during surgery (prior to entry into bladder).
Intravesical gemcitabine instilled into bladder during surgery (drained prior to entry into bladder).
Locations(1)
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NCT04865939