跳至主要内容
临床试验/jRCTs041250025
jRCTs041250025招募中不适用

Effect of continuous postoperative bladder lavage for upper urothelial carcinoma on prevention of intravesical recurrence. (BLUC Study)

未提供0 个研究点目标入组 280 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
280
主要终点
duration of recurrence-free period in the bladder

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized Controlled Trial
干预模型
Parallel Assignment
主要目的
Prevention Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
18age old over 至 80age old under(—)
性别
All

入选标准

  • Disease name Upper urothelial carcinoma (cancer of the renal pelvis and ureter) Stage 0a-3 (cTa-T3), cN0, cM0
  • Age. 18 to 80 years old
  • Performance Status (ECOG). 0 to 1
  • Patients with written consent to participate in the study

排除标准

  • Those who have a history of treatment for bladder cancer prior to radical nephrectomy for UTUC
  • Those who have a history of treatment for UTUC in the past
  • Those who have metastatic lesions (lymph nodes, other organs, etc.) at the time of diagnosis
  • Those who have a history of radiation therapy
  • Those who are pregnant or may be pregnant, or are breastfeeding
  • Those who are judged by the principal investigator or sub-investigator to be unsuitable as research subjects

结局指标

主要结局

duration of recurrence-free period in the bladder

时间窗: 108-week observation period from the date of surgery

The period from the date of surgery to the date of confirmation of recurrence by cystoscopy. In cases with no follow-up, the period is terminated on the last day of confirmed recurrence-free period before the loss of follow-up. However, for cases without 108-week follow-up, data on the presence or absence of recurrence at the last observation will be used. Deaths without intracisternal recurrence within 108 weeks shall be treated as no intracisternal recurrence.

次要结局

未报告次要终点

研究者

发起方
未提供

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