Diagnostic Relevance of Laser Confocal Microscopy for the Screening of Upper Urinary Tract Tumors

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Diagnostic Relevance of Laser Confocal Microscopy During Reno-ureteroscopy in the Context of the Screening and Follow-up of Upper Urinary Tract Tumors

Conditions
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Hematuria, Nephrolithiasis, Cancer of Urinary Tract, Ureteropelvic Junction Obstruction

Intervention / Treatment
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* Device: Laser confocal microscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser confocal microscopy<br>Patients undergoing a reno-ureteroscopy for diagnosis or treatment indication will follow a laser confocal microscopy procedure. | Device: Laser confocal microscopy<br>* Patients undergoing a reno-ureteroscopy for diagnosis or treatment indication will receive an intra-vesical instillation of fluorescein (0.1%) for 5 minutes, followed by the laser confocal microscopy procedure.<br>* Other names: Cell-vizio;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic relevance of laser confocal microscopy compared to the cytological and histological data, during reno-ureteroscopy according to Chang's reference criteria | 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 | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter- and intra-observer diagnostic concordance | Anonymized videos of the intervention will be reviewed at the end of the study by a naive surgeon to assess inter-observer concordance. A concordance Kappa test will be performed | 24 months | 
| Surgery duration |  | 24 months | 
| Reference atlas | Videos and images quality will be assessed to compile them in a refence atlas | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser Confocal Microscopy, Superior Urinary Tract Tumors