En-bloc vs Conventional Resection of Primary Bladder Tumor: Prospective Randomized Multicenter Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 384
- 试验地点
- 2
- 主要终点
- The pathological staging assessment for eTURB compared to cTURB
研究概览
简要总结
Based on current evidence, we hypothesize that eTURB represents an improvement in the surgical management of NMIBC. The resection is more precise and complete compared to cTURB. Moreover, the quality of an en-bloc specimen, including the tumor with its adjacent bladder wall layers, allows an accurate pathological review which leads to correct risk allocation and therapy.
To answer these questions, we designed a RCT comparing eTURB with cTURB. Primary outcome of our study will be the accuracy of pathological staging assessment measured by the presence of detrusor muscle in the specimen as a surrogate parameter for quality of 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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
The pathological staging assessment for eTURB compared to cTURB
时间窗: 4 weeks
The primary objective of the study is to assess whether eBLOC is associated with a higher rate of detrusor muscle in the pathologic specimen, compared to cTURB
次要结局
- Residual disease within 3 months after initial TURB(3 months)
- Recurrence-free survival(up to 5 years)
- Occurrence of obturator reflex(1 day)
- Number of participants with obturator reflex(1 day)
- Number of tumors with positive lateral and deep resection margin(4 weeks)
- Operative time(1 day)
- Number of participants with bladder perforation(7 days)
- Upstaging of disease upon second look transurethral resection surgery(6 weeks)
- Number of tumors with evaluable lateral and deep resection margin(4 weeks)
- Number of participants with conversion to other resection technique(1 day)
- Number of participants with persistent disease at 2nd look TURB(6 weeks)
研究者
David D'Andrea
M.D.
Medical University of Vienna