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

Primary Purpose

Hematuria, Nephrolithiasis, Cancer of Urinary Tract

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Laser confocal microscopy

About this trial

This is an interventional diagnostic trial for Hematuria focused on measuring Laser Confocal Microscopy, Superior Urinary Tract Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Groupement des Hôpitaux de l'Institut Catholique de Lille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laser confocal microscopy

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Surgery duration

Reference atlas

Videos and images quality will be assessed to compile them in a refence atlas

Full Information

NCT ID

NCT02276924

First Posted

August 29, 2014

Last Updated

March 19, 2019

Sponsor

Lille Catholic University

1. Study Identification

Unique Protocol Identification Number

NCT02276924

Brief Title

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

Acronym

UROVISIO

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

October 2013 (Actual)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lille Catholic University

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hematuria, Nephrolithiasis, Cancer of Urinary Tract, Ureteropelvic Junction Obstruction

Keywords

Laser Confocal Microscopy, Superior Urinary Tract Tumors

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Laser confocal microscopy

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Laser confocal microscopy

Other Intervention Name(s)

Cell-vizio

Intervention Description

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.

Primary Outcome Measure Information:

Title

Diagnostic relevance of laser confocal microscopy compared to the cytological and histological data, during reno-ureteroscopy according to Chang's reference criteria

Description

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Inter- and intra-observer diagnostic concordance

Description

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

Time Frame

24 months

Title

Surgery duration

Time Frame

24 months

Title

Reference atlas

Description

Videos and images quality will be assessed to compile them in a refence atlas

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Louis Bonnal, MD

Organizational Affiliation

Groupement des Hôpitaux de l'Institut Catholique de Lille

Official's Role

Principal Investigator

Facility Information:

Facility Name

Groupement des Hôpitaux de l'Institut Catholique de Lille

City

Lille

State/Province

Nord Pas-de-Calais

ZIP/Postal Code

59000

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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