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

Lille Catholic University

Status: Completed

Conditions: Hematuria; Cancer of Urinary Tract; Ureteropelvic Junction Obstruction; Nephrolithiasis

Treatments: Device: Laser confocal microscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02276924

RC-P0026

Details and patient eligibility

About

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.

Full 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).

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Laser confocal microscopy

Experimental group

Description:

Patients undergoing a reno-ureteroscopy for diagnosis or treatment indication will follow a laser confocal microscopy procedure.

Treatment:

Device: Laser confocal microscopy