This trial is active, not recruiting.

Conditions hematuria,, nephrolithiasis, cancer of urinary tract, ureteropelvic junction obstruction
Treatment laser confocal microscopy
Sponsor Lille Catholic University
Start date October 2013
End date October 2016
Trial size 29 participants
Trial identifier NCT02276924, RC-P0026


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Patients undergoing a reno-ureteroscopy for diagnosis or treatment indication will follow a laser confocal microscopy procedure.
laser confocal microscopy Cell-vizio
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.

Primary Outcomes

Diagnostic relevance of laser confocal microscopy compared to the cytological and histological data, during reno-ureteroscopy according to Chang's reference criteria
time frame: 24 months

Secondary Outcomes

Inter- and intra-observer diagnostic concordance
time frame: 24 months
Surgery duration
time frame: 24 months
Reference atlas
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Diagnostic Relevance of Laser Confocal Microscopy During Reno-ureteroscopy in the Context of the Screening and Follow-up of Upper Urinary Tract Tumors
Principal investigator Jean-Louis Bonnal, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Lille Catholic University.