A Phase III Prospective Multicenter Randomized Comparison of Transurethral Resection by Mean of White Light and Narrow Band Imaging.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 188
- 试验地点
- 3
- 主要终点
- Recurrence free survival rate
研究概览
简要总结
To date, fluorescence and narrow band imaging cystoscopy have been tested in many prospective within patient trials but only as an "add on" procedure. This results in a bias that does not allow to determine the real impact of such innovative technologies on bladder cancer management. Hereby we propose the first prospective randomized trial which compares narrow band imaging trans urethral resection as a stand alone procedure versus white light transurethral resection. The primary end point is to assess the recurrence rate of bladder cancer lesions with each treatment modality. The study is designed to disclose an inferior recurrence rate (estimated 10%) in the group treated by narrow band imaging transurethral resection respect to the control group, treated by standard transurethral resection.
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
- •All patients must be older than 18 years of age and female patients who are pregnant, breast feeding or not on adequate contraceptive measures will be excluded.
- •All patients will provide a written informed consent prior to the study.
- •Consecutive patients from 2 centers in Liguria (National Institute for Cancer Research - Genova and Centro Urologico di Eccellenza ASL 1 - Imperia) with overt or suspected non muscle invasive bladder cancer, including Cis detected by mean of random biopsies or a positive urinary cytology, will be included in the study and randomized to 2 treatments A, B arms.
排除标准
- •Patients with muscle invasive bladder cancer will be excluded.
- •Patients submitted to immediate radical cystectomy after transurethral resection, irrespective of the clinical stage, will be excluded.
研究组 & 干预措施
Standard transurethral resection
Patients will be submitted to standard white light transurethral resection and/or cold cup biopsies of all visible lesions known or suspected to be bladder cancer; 6 random cold cup biopsies from healthy mucosa of bladder trigone, anterior, posterior and lateral walls will be taken in case of a second transurethral resection of newly diagnosed high grade non muscle invasive bladder cancer or of recurrent high grade non muscle invasive bladder cancer
干预措施: Standard transurethral resection (Procedure)
Narrow band imaging transurethral resection
The system will be switched to narrow band imaging by simply pushing a button. Transurethral resection and/or cold cup biopsies of all visible lesions known or suspected to be bladder cancer will be performed; 6 random cold cup biopsies from healthy mucosa of bladder trigone, anterior, posterior and lateral walls will be taken in case of a second transurethral resection of newly diagnosed high grade non muscle invasive bladder cancer or of recurrent high grade non muscle invasive bladder cancer.
干预措施: Narrow band imaging transurethral resection (Procedure)
结局指标
主要结局
Recurrence free survival rate
时间窗: One year
次要结局
- Detection rate(At the end of enrollment)
研究者
Paolo Puppo
MD
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy