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Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma
Sponsor: University of Texas Southwestern Medical Center
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
132
Start Date
2021-11-29
Completion Date
2031-11-01
Last Updated
2025-07-17
Healthy Volunteers
No
Interventions
sterile water irrigation
Continuous irrigation of bladder with sterile water during surgery (prior to entry into bladder).
Gemcitabine
Intravesical gemcitabine instilled into bladder during surgery (drained prior to entry into bladder).
Locations (1)
University of Texas Southwestern Medical Center
Dallas, Texas, United States