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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary: 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).
Sponsor: Lille Catholic University

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Lille Catholic University

Dates:
Date Received: August 29, 2014
Date Started: October 2013
Date Completion: October 2016
Last Updated: September 19, 2016
Last Verified: September 2016