Comparing Gemcitabine and Sterile Water Irrigation Against Bladder Cancer Return
Compares bladder rinsing with gemcitabine and sterile water in patients having upper tract urothelial surgery.
Plain-language title generated from the registry record
Registry title: Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma
Key facts
- Where
- Dallas, United StatesSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with biopsy-proven cancer of the upper urinary tract (kidney pelvis or ureter) who will have surgery to remove it. It compares two ways of lowering the chance of cancer coming back in the bladder.
- Age
- 18 to 90 years
- Sex
- Men and women can join.
- Disease stage
- Urothelial cancer of the renal pelvis or ureter, proven by biopsy, with surgery planned to remove it (distal ureterectomy or nephroureterectomy) with the aim of removing all of the disease.
- Earlier treatment
- No bladder cancer in the last three years, or a gap of at least three years free of disease after earlier bladder cancer.
Main reasons for not taking part
- Bladder cancer now, or in the past with less than three years free of disease
- Upper tract cancer in both sides at the same time
- Plan to remove the whole bladder (radical cystectomy)
- Small bladder capacity (less than 100 mL)
- Past allergic reaction to gemcitabine or similar compounds or other study agents
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Source: NCT04865939, who can take part
Where in United States
- University of Texas Southwestern Medical CenterDallas, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Texas Southwestern Medical Center
- Trial code
- NCT04865939
- Record updated
- 17 August 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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 of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:; Has not undergone a hysterectomy or bilateral oophorectomy; or; Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months); Ability to understand and the willingness to sign a written informed consent.
Exclusion: Concurrent or prior diagnosis of bladder cancer with a disease-free interval of less than three years; Synchronous bilateral upper tract urothelial carcinoma (prior history of contralateral UTUC is permissible with a disease-free interval of more than three years); History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or other agents used in study; Plan for radical cystectomy; Small bladder capacity (< 100 mL).