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

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ClinicalTrials.gov Identifier: NCT02276924
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Lille Catholic University

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : October 2013
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

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Arms and Interventions
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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 Name: Cell-vizio


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Inter- and intra-observer diagnostic concordance [ Time Frame: 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

  2. Surgery duration [ Time Frame: 24 months ]
  3. Reference atlas [ Time Frame: 24 months ]
    Videos and images quality will be assessed to compile them in a refence atlas


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276924


Locations
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France
Groupement des Hôpitaux de l'Institut Catholique de Lille
Lille, Nord Pas-de-Calais, France, 59000
Sponsors and Collaborators
Lille Catholic University
Investigators
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Principal Investigator: Jean-Louis Bonnal, MD Groupement des Hôpitaux de l'Institut Catholique de Lille
More Information
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Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT02276924    
Other Study ID Numbers: RC-P0026
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: September 2016
Keywords provided by Lille Catholic University:
Laser Confocal Microscopy
Superior Urinary Tract Tumors
Additional relevant MeSH terms:
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Urologic Neoplasms
Nephrolithiasis
Kidney Calculi
Hematuria
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
 Calculi
Pathological Conditions, Anatomical
Urination Disorders
Hemorrhage
Pathologic Processes
Urogenital Neoplasms
Neoplasms by Site
Neoplasms