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

What this Trial Is About

Upper tract urothelial carcinoma is a rare form of cancer that affects the urinary tract and accounts for 5-10% of urothelial malignancies. After surgical removal of the affected kidney and ureter, up to half of patients experience recurrence of bladder cancer. Researchers are comparing two methods aimed at preventing this recurrence: intravesical gemcitabine chemotherapy and continuous bladder irrigation with sterile water. This trial seeks to determine if sterile water irrigation is as effective as gemcitabine in reducing bladder tumor recurrence, addressing concerns about chemotherapy usage and accessibility. Participants are randomly assigned to receive either gemcitabine instilled into the bladder during surgery with a dwell time of 1 to 3 hours or continuous irrigation of sterile water through a urinary catheter for 1 to 3 hours, with around 4 to 16 liters of water instilled. The gemcitabine is drained before entering the bladder, while the sterile water irrigation starts at the beginning of surgery and ends just before bladder entry. This approach is designed to assess whether sterile water irrigation can be a simpler and safer alternative to chemotherapy. Throughout the trial, participants will be monitored for bladder cancer recurrence at 1 and 2 years after treatment. Safety assessments include tracking adverse events within 30 days following treatment. The study involves informed consent, and participants will undergo regular follow-up visits to evaluate outcomes. This trial is sponsored by the University of Texas Southwestern Medical Center and plans to complete by November 2031.

Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma