Prospective Randomized Trial in Low Grade Bladder Tumors: Active Surveillance vs Endoscopic Fulguration.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Progression rate
研究概览
简要总结
Biological behabiour of low grade bladder cancer tumors is well known. They have a very high rate of recurrences during their follow up but very low (less than 1%) risk of progression.
Until now, the gold standard of any bladder recurrence for this patients is performing an immediate transurethral ressection of the tumor.
This surgery has risk of complications and, due to the low risk of these subgroup of tumors, sometimes it becomes an overtreatment for the patients.
This is the reason why new conservative or less invasive surgeries are proposed to follow up and treat these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent Ta-T1a (above muscularis mucosa) LOW GRADE bladder tumor
- •Accept cystoscopy surveillance
- •Main lession less than 10mm
- •Less than 7 lesions
- •Negative or low grade cytology
- •No solid aspect
排除标准
- •previous High grade bladder cancer tumors
- •previous Cis
- •previous Upper Urinary Tract tumor
- •previous pelvic radiotherapy
- •hematuria
- •meatal localisation
结局指标
主要结局
Progression rate
时间窗: two years
Number of patients that progress during the follow up
Complications rate
时间窗: two years
Number and grade of complications in both arms. Clavien Dindo Scale will be used
次要结局
- recurrence rate(two years)
- quality of life measured with CAVICAVENMI questionnaire(two years)