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

Sponsor

Lille Catholic University (Other)

Overall Status

Completed

CT.gov ID

NCT02276924

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematuria Nephrolithiasis Cancer of Urinary Tract Ureteropelvic Junction Obstruction	Device: Laser confocal microscopy	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Oct 1, 2016

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Laser confocal microscopy Patients undergoing a reno-ureteroscopy for diagnosis or treatment indication will follow a laser confocal microscopy procedure.	Device: Laser 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. Other Names: Cell-vizio

Arm

Intervention/Treatment

Experimental: Laser confocal microscopy

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

Device: Laser 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.

Other Names:

Cell-vizio

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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