The aim of this study is to evaluate the effectiveness and safety of intravesical gemcitabine instillation during operation to prevent intravesical recurrence after radical nephroureterectomy in upper urinary tract urothelial carcinoma.
Study Design: Intervention Model: Single Group Assignment Masking: Open Label Primary Outcome Measures: Two year recurrence-free survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. Secondary Outcome Measures: Time to recurrence in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. Overall survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. Safety of intravesical 2000mg/52.6ml gemcitabine instillation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
134
Intravesical 2000mg/52.6ml gemcitabine instillation during operation to prevent intravesical recurrence after radical nephroureterectomy in upper urinary tract urothelial carcinoma
Intravesical 52.6ml normal saline instillation after radical nephroureterectomy in upper urinary tract urothelial carcinoma
National Cancer Center
Goyang, South Korea
RECRUITINGAsan Medical Center
Seoul, South Korea
RECRUITINGKorea University Anam Hospital
Seoul, South Korea
RECRUITINGTwo year recurrence-free survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. The recurrence will be assessed by CT scan and cystoscopic exam.
Analysis of recurrence status at 2 years from intravesical instillation of 2000mg/52.6ml gemcitabine
Time frame: Two years
Time to recurrence in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. The recurrence will be assessed by CT scan and cystoscopic exam.
Analysis of time from starting intravesical instillation of 2000mg/52.6ml gemcitabine to recurrence
Time frame: six years
Overall survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group.
Analysis of survival status due to any cause at six years from intravesical instillation of 2000mg/52.6ml gemcitabine
Time frame: six years
CT cystography finding at one week after surgery.
Evaluation of leakage at CT cystography at one week from intravesical instillation of 2000mg/52.6ml gemcitabine
Time frame: one week
International Prostate Symptom Score questionnaire at one week after surgery.
Evaluation of survey with International Prostate Symptom Score questionnaire a one week after surgery
Time frame: one week
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Samsung Medical Center
Seoul, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITING