Upper Tract Urothelial Carcinoma Clinical Trial
Official title:
Peking University First Hospital
This clinical trial is designed to evaluate the efficacy of single immediate intravesical chemotherapy instillation in the prevention of bladder recurrence after diagnostic ureteroscopy for upper tract urothelial carcinoma (UTUC) patients.
INTRODUCTION
Upper tract urothelial carcinomas (UTUC) are relatively uncommon compared to bladder cancer
and account for only 5-10% of urothelial carcinomas [Munoz et al., 2000; Siegel et al., 2012;
Rouprêt et al. 2015], with an estimated annual incidence in Western countries of ~2 cases per
100,000 inhabitants. In 17% of cases, concurrent bladder cancer is present [Cosentino et al.,
2013].
Urinary cytology, cystoscopy and computed tomograpy urography should be performed as the
standard diagnostic work-up with the grade A of recommendation [Rouprêt et al., 2015].
Diagnostic ureteroscopy and biopsy should be performed, certainly in cases where additional
information will impact treatment decisions. Such ureteroscopic biopsies can determine tumour
grade in 90% of cases with a low false-negative rate [Rojas et al., 2012]. Ureteroscopy can
prove invaluable in cases of suspected UTUC, especially when the diagnosis is equivocal, or
if nephron sparing surgery is considered. However, it can pose potential hindrances,
including difficulty in obtaining adequate tissue, inconsistent pathologic interpretation and
prediction, and a high rate of upgrading and upstaging at the time of nephroureterectomy
[Potretzke et al., 2015].
Recurrence in the bladder after management of UTUC occurs in 22-47% of UTUC patients [Xylinas
et al., 2012; Zigeuner et al., 2006; Novara et al., 2008], compared with 2-6% in the
contralateral upper tract [Li et al., 2010; Novara et al., 2009]. At our institution, we
reported that 30.8% of UTUC patients developed intravesical recurrence, which was in line
with the global trend [Fang et al., 2013]. Although the risk factors for development of
bladder tumor post surgical management of UTUC were previously studied, considerable
variations were observed in the literature. In previously published studies, we pointed out
that lower tumor grade, tumor multifocality, concomitant carcinoma in situ (CIS), tumors
located in the lower ureter, ureteroscopy history and unmethylated promoter of GDF15 and
RASSF1A promoters were considered as predictors to develop bladder recurrence after surgery
by univariate and multivariate analysis [Fang et al., 2013, Xiong et al., 2015]. As an
effective tool to evaluate UTUCs visually or by biopsy, ureteroscopy was selectively used in
early UTUC patients without atypical radiography. It was our hypothesis that retrograde flow,
increased urine flow rate and intraluminal pressure might lead to the shedding of tumor cells
(intraluminal tumor seeding is thought to contribute to intravesical recurrence after
nephroureterectomy), which implant in the bladder to develop recurrences [Xiong et al.,
2015].
AIM OF THE WORK This clinical trial is designed to evaluate the efficacy of single immediate
intravesical chemotherapy instillation in the prevention of bladder recurrence after
diagnostic ureteroscopy for UTUCs.
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