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RECRUITING
NCT04865939
PHASE3

Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma

Sponsor: University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

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

PROCEDURE

sterile water irrigation

Continuous irrigation of bladder with sterile water during surgery (prior to entry into bladder).

DRUG

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