A Multi-center, International Study to Compare Use of Narrow Band Imaging (NBI) Versus White Light(WL) During Transurethral Resection of Bladder Tumors (TURB) to Asses Recurrence of Bladder Cancer in Terms of Safety and Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 965
- 主要终点
- Number of Participants With Recurrence and Recurrence Rate at 1 Year Following Narrow Band Imaging and TURB (Arm A) Versus White Light Trans Urethral Resection of Bladder Cancer (TURB) (Arm B) in Patients With Non Muscle Invasive (pTa/T1) Bladder Cancer.
研究概览
简要总结
The purpose of this study is to compare the recurrence rate at 1 year following Narrow Band Imaging and trans-urethral resection of bladder tumor with White Light and TURB in patients with non-muscle invasive bladder cancer.
详细描述
Currently bladder tumors are diagnosed visually with standard cystoscopy that uses white light, or light that is generated encompassing the entire visual spectrum. Some tumors such as carcinoma in situ may not be visible using white light and require patients to undergo random bladder biopsies in order to find the cancer. Recently the development of photodynamic agents have been shown to enhance these procedures to accomplish better resection and identify over-looked tumors. However, these methods often require the instillation of dyes into the bladder as well as specialized cystoscopes. Narrow band imaging (NBI) is now available which uses a special filter to limit the light to only certain wavelengths which allows the identification of areas of increased vascularity or abnormalities without the need for dyes. NBI has been investigated in gastro-intestinal disease and found to be beneficial. Early reports in urology suggest that this technology may reduce the number of tumors that are missed which could impact the recurrence rate of bladder tumors, but this is not known at this time.
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
- •Patients scheduled for treatment of primary or recurrent non-muscle invasive bladder cancer
- •Patients greater than 18 years of age
- •No tumors in the upper tract (kidneys or ureters)
- •No previous pelvic radiation
排除标准
- •Gross hematuria at the time of resection making visualization with NBI not possible
- •Participation in other clinical studies with investigations drugs concurrently or within 30 days.
- •Pregnancy
- •Conditions associated with a risk of poor compliance or unwilling to follow up
研究组 & 干预措施
Narrow Band Imaging
Narrow Band Imaging (NBI)
干预措施: Narrow Band Imaging (Device)
White Light Trans Urethral Resection
White Light Trans Urethral Resection
干预措施: White Light (Device)
结局指标
主要结局
Number of Participants With Recurrence and Recurrence Rate at 1 Year Following Narrow Band Imaging and TURB (Arm A) Versus White Light Trans Urethral Resection of Bladder Cancer (TURB) (Arm B) in Patients With Non Muscle Invasive (pTa/T1) Bladder Cancer.
时间窗: 1 year after treatment
The primary outcome measure was recurrence rate at 1 year. A recurrence was defined as the new occurrence of a bladder cancer at the same site as or at a different site from the index cancer.
次要结局
- Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System.(30 days)
- Recurrence Rate Related to Additional Treatment Following TURB.(Until 135 days)
- Number of Participants With Persistence/Recurrence of Tumors at First 3 Month Follow up After NBI Versus WL Cystoscopy and Tumor Resection(3 months after treatment)
- Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment.(peri-operative)