跳至主要内容
临床试验/NCT06941038
NCT06941038已完成不适用

Effect of Intravesical Chemotherapy on Disease Recurrence in Patients Undergoing Nephroureterectomy for Upper Urinary Tract Urothelial Carcinoma

Ankara Etlik City Hospital1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2021年6月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
270
试验地点
1
主要终点
To evaluate the relationship between intravesical chemotherapy administered intraoperatively or postoperatively and bladder recurrence.

研究概览

简要总结

Upper urinary tract urothelial carcinoma (UTUC) accounts for 5%-10% of urothelial malignancies, with up to 50% of patients developing bladder recurrence post-RNU. High-risk UTUC (≥pT2, high-grade, or N+ disease) necessitates aggressive management. Intravesical chemotherapy mitigates recurrence risk, yet optimal timing-intraoperative vs. postoperative-remains unclear. This study evaluates intraoperative epirubicin instillation during RNU compared to postoperative administration and no instillation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • primary high-risk UTUC.

排除标准

  • prior bladder cancer,
  • low-risk UTUC (managed conservatively),
  • metastatic disease,
  • incomplete follow-up

结局指标

主要结局

To evaluate the relationship between intravesical chemotherapy administered intraoperatively or postoperatively and bladder recurrence.

时间窗: 365 days from the first instillation

次要结局

未报告次要终点

研究者

发起方
Ankara Etlik City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Cagri Akpinar

M.D

Ankara Etlik City Hospital

研究点 (1)

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