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
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.
Description
Upper tract urothelial carcinoma is a relatively rare disease, accounting for 5-10% of urothelial malignancies. Following radical nephroureterectomy (RNU), recurrence of urothelial carcinoma in the bladder (UCB) is reported in up to 50% of cases. Although the mechanism of bladder cancer recurrence following RNU is still controversial, recent evidence suggest that these tumors have similar clonal origin to upper tract tumors, supporting the theory of downstream seeding; specifically, that manipulation of the upper tract during surgery results in shedding of tumor cells which then implant in the…
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Biopsy proven UTUC with plan for excisional surgery (distal ureterectomy or nephroureterectomy) with curative intent * Age 18 - 90 years * Life expectancy \> 1 year * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * A female…
Interventions
- Proceduresterile water irrigation
Continuous irrigation of bladder with sterile water during surgery (prior to entry into bladder).
- DrugGemcitabine
Intravesical gemcitabine instilled into bladder during surgery (drained prior to entry into bladder).
Location
- University of Texas Southwestern Medical CenterDallas, Texas