Trimodalitets-studie Hvidt Lys vs. NBI vs. PDD Ved Detektion af Flad Dysplasi og CIS Ved TURB
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 4
- 主要终点
- Detection of CIS
研究概览
简要总结
All patients planned for PDD guided TURB can be included in this study. Two different optics with PDD and NBI are applied to the resectoscope in addition to regular WL.
First, a WL cystoscopy is made and any suspect areas are noted on the registration form, then NBI is used and any suspect areas are noted and finally the cystoscopy is made with PDD with registration of any additional findings. To adjust for bias introduced by photo bleaching, the second part of the study will be performed with PDD as the second modality. Any flat lesions will be biopsied if they appear suspicious in one of the modalities.
The registration form is completed by the surgeon, once the pathology results are known.
A total number of 152 patients is planned to be included.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 undergoing PDD according to the Danish guidelines
排除标准
- •Patients not fulfilling the inclusion criteria
结局指标
主要结局
Detection of CIS
时间窗: Baseline
次要结局
未报告次要终点
研究者
Jørgen Bjerggaard Jensen
Professor
Aarhus University Hospital
