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

Diagnostic Relevance of Laser Confocal Microscopy During Reno-ureteroscopy in the Context of the Screening and Follow-up 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.

Study Overview

• Status: Completed
• Conditions: Nephrolithiasis; Hematuria; Ureteropelvic Junction Obstruction; Cancer of Urinary Tract
• Intervention / Treatment: Device: Laser confocal microscopy

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: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nord Pas-de-Calais
    • Lille, Nord Pas-de-Calais, France, 59000
      • Groupement des Hôpitaux de l'institut Catholique de Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Cell-vizio

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic relevance of laser confocal microscopy compared to the cytological and histological data, during reno-ureteroscopy according to Chang's reference criteria	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	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter- and intra-observer diagnostic concordance	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	24 months
Surgery duration		24 months
Reference atlas	Videos and images quality will be assessed to compile them in a refence atlas	24 months

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Investigators: Principal Investigator: Jean-Louis Bonnal, MD, Groupement des Hôpitaux de l'institut Catholique de Lille

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: August 29, 2014
• First Submitted That Met QC Criteria: October 27, 2014
• First Posted (Estimate): October 28, 2014

Study Record Updates

• Last Update Posted (Actual): March 21, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Laser Confocal Microscopy; Superior Urinary Tract Tumors
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Hemorrhage; Urination Disorders; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis; Urologic Neoplasms; Hematuria
• Other Study ID Numbers: RC-P0026