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

Overview

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 Title of Study: “Diagnostic Relevance of Laser Confocal Microscopy During Reno-ureteroscopy in the Context of the Screening and Follow-up of Upper Urinary Tract Tumors”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2016

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).

Interventions

  • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lille Catholic University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jean-Louis Bonnal, MD, Principal Investigator, Groupement des Hôpitaux de l’Institut Catholique de Lille

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