跳至主要内容
临床试验/NCT02313662
NCT02313662已完成不适用

Trimodalitets-studie Hvidt Lys vs. NBI vs. PDD Ved Detektion af Flad Dysplasi og CIS Ved TURB

Aarhus University Hospital4 个研究点 分布在 2 个国家目标入组 153 人开始时间: 2014年12月最近更新:
适应症

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

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

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jørgen Bjerggaard Jensen

Professor

Aarhus University Hospital

研究点 (4)

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