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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

Tracking Information
First Submitted Date  ICMJE August 29, 2014
First Posted Date  ICMJE October 28, 2014
Last Update Posted Date March 21, 2019
Actual Study Start Date  ICMJE October 2013
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2014)
  • 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
  • Surgery duration [ Time Frame: 24 months ]
  • Reference atlas [ Time Frame: 24 months ]
    Videos and images quality will be assessed to compile them in a refence atlas
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diagnostic Relevance of Laser Confocal Microscopy for the Screening of Upper Urinary Tract Tumors
Official Title  ICMJE Diagnostic Relevance of Laser Confocal Microscopy During Reno-ureteroscopy in the Context of the Screening and Follow-up of Upper 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Hematuria
  • Nephrolithiasis
  • Cancer of Urinary Tract
  • Ureteropelvic Junction Obstruction
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Laser confocal microscopy
Patients undergoing a reno-ureteroscopy for diagnosis or treatment indication will follow a laser confocal microscopy procedure.
Intervention: Device: Laser confocal microscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 19, 2016)
29
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2014)
30
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02276924
Other Study ID Numbers  ICMJE RC-P0026
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lille Catholic University
Study Sponsor  ICMJE Lille Catholic University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean-Louis Bonnal, MD Groupement des Hôpitaux de l'Institut Catholique de Lille
PRS Account Lille Catholic University
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP