Cancer of Urinary Tract, Hematuria, Nephrolithiasis, Ureteropelvic Junction Obstruction
Conditions
Keywords
Laser Confocal Microscopy, Superior Urinary Tract Tumors
Brief summary
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
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).
Interventions
DEVICELaser confocal microscopy
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.
Sponsors
Lille Catholic University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic relevance of laser confocal microscopy compared to the cytological and histological data, during reno-ureteroscopy according to Chang's reference criteria | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inter- and intra-observer diagnostic concordance | 24 months | 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 |
| Surgery duration | 24 months | — |
| Reference atlas | 24 months | Videos and images quality will be assessed to compile them in a refence atlas |
Countries
France
Outcome results
None listed