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NCT Number: NCT02276924

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

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.

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Key information

Conditions

Hematuria Cancer of Urinary Tract Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemorrhage Kidney Diseases Male Urogenital Diseases Multicystic renal dysplasia, bilateral Neoplasms Neoplasms by Site Nephrolithiasis Pathologic Processes Pathological Conditions, Signs and Symptoms Ureteropelvic Junction Obstruction Urination Disorders Urogenital Diseases Urogenital Neoplasms Urolithiasis Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupement des Hôpitaux de l'Institut Catholique de Lille

Lille, Hauts-de-France, 59000, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laser confocal microscopy

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Registry information

Official study title

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

Acronym: UROVISIO

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 28, 2014
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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