Diagnostic Relevance of Laser Confocal Microscopy During Reno-ureteroscopy in the Context of the Screening and Follow-up of Upper Urinary Tract Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Diagnostic relevance of laser confocal microscopy compared to the cytological and histological data, during reno-ureteroscopy according to Chang's reference criteria
研究概览
简要总结
Upper Urinary Tract Tumors have an incidence of 1 to 2 cases for 100 000 persons per year. The standard treatment for these tumors is the ablation of the kidney, ureter and a part of the bladder surrounding the ureteral orifice. The development of new diagnosis and treatment techniques through natural routes opens the possibility to use conservative treatments. The investigators hypothesis is that during a reno-ureteroscopy, laser confocal microscopy will allow the discrimination between normal and pathologic urothelium by microscopic analysis. This will prevent the systematic use of biopsies which are often difficult and iatrogenic.
详细描述
The objective of the present study is to assess contribution of laser confocal microscopy in diagnosing of upper urinary tract tumors during a reno-uteroscopy compared to analysing of architectural elements (vascular characteristics, organization) and cellular (morphology, cohesion, border).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Any legally adult fully informed patient who consent to participate to the study
- •Patient followed by the Urology Department
- •Indication for a diagnosis or treatment reno-ureteroscopy
- •Coverage of the social insurance
排除标准
- •Minor Patient
- •Pregnancy or breast feeding
- •Concomitant treatment (for example beta-blocker)
- •Contra-indication to general anaesthesia
- •Hypersensitivity to sodium fluorescein
- •Medical history of cardio-pulmonary disease (myocardial infarction, cardiovascular event, bronchospasm ...) due to fluorescein instillation
- •Medical history of asthma or allergy due to fluorescein instillation
研究组 & 干预措施
Laser confocal microscopy
Patients undergoing a reno-ureteroscopy for diagnosis or treatment indication will follow a laser confocal microscopy procedure.
干预措施: Laser confocal microscopy (Device)
结局指标
主要结局
Diagnostic relevance of laser confocal microscopy compared to the cytological and histological data, during reno-ureteroscopy according to Chang's reference criteria
时间窗: 24 months
According to Chang's reference criteria, we will define the urothelial microarchitecture (normal, papillary, inflammatory, low grade lesion, high grade lesion, in situ carcinoma). The diagnostic relevance of the MCL (absence or presence of the lesion) will be compare to the reference tests calculating sensibility, specificity and predictive values
次要结局
- Surgery duration(24 months)
- Reference atlas(24 months)
- Inter- and intra-observer diagnostic concordance(24 months)