Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in mean cells count before versus after liter 1 of CBI
研究概览
简要总结
The purpose of this pilot study is to determine if washing out the bladder with large volumes of saline after surgical removal of bladder tumors helps to decrease the number of loose cells floating within the bladder after surgery. Anticipated decrease in tumor recurrence and/or progression rates will be measured.
详细描述
Bladder tumor recurrence after resection of non-muscle invasive bladder cancer (NMIBC) occurs in 50-70% of patients despite the use of adjuvant anticancer therapy after surgery. This is a single-arm, non-randomized pilot study looking to determine whether post-Transurethral Resection of Bladder Tumor (TURBT) cells counts differ significantly between continuous washout of the bladder (CBI) with normal saline compared to pre-CBI wash out. Anticipated decrease in tumor recurrence and/or progression rates will also be measured, and each participant will act as their own internal control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients age 18 years and older diagnosed with a bladder mass on cystoscopy or imaging study
- •Primary bladder tumor occurrence
排除标准
- •Patients with unresectable bladder tumors, as determined at the time of diagnosis or TURBT , or imaging concerning of T2 or higher disease
- •Patients with bladder perforation at the time of TURBT, which is a contraindication to CBI
- •Patients from vulnerable populations, including but not limited to impaired subjects, pregnant women, prisoners, family members of the study team
- •Any previous history of bladder tumor resection or intravesical chemotherapy/immunotherapy
- •History of previous pelvic radiation
- •Bladder tumor volume > 5 cm, involvement of prostatic urethra, or any evidence of hydronephrosis on imaging
结局指标
主要结局
Change in mean cells count before versus after liter 1 of CBI
时间窗: Immediately after CBI procedure.
The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
Change in mean cells count before versus after liter 3 of CBI
时间窗: Immediately after CBI procedure.
The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
Change in mean cells count before versus after liter 4 of CBI
时间窗: Immediately after CBI procedure.
The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
Change in mean cells count before versus after liter 5 of CBI
时间窗: Immediately after CBI procedure.
The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
Change in mean cells count before versus after liter 2 of CBI
时间窗: Immediately after CBI procedure.
The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
次要结局
- Recurrence rate of patients who underwent CBI post TURBT.(2 years after end of treatment)
- Progression rate of patients who underwent CBI post TURBT.(2 years after end of treatment)