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

NCT ID: NCT02276924

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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).

Conditions

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Hematuria Nephrolithiasis Cancer of Urinary Tract Ureteropelvic Junction Obstruction

Keywords

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Laser Confocal Microscopy Superior Urinary Tract Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Laser confocal microscopy

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

Group Type EXPERIMENTAL

Laser confocal microscopy

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Cell-vizio

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lille Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Louis Bonnal, MD

Role: PRINCIPAL_INVESTIGATOR

Groupement des Hôpitaux de l'Institut Catholique de Lille

Locations

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Groupement des Hôpitaux de l'Institut Catholique de Lille

Lille, Hauts-de-France, France

Site Status

Countries

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France

References

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Marien A, Rock A, Maadarani KE, Francois C, Gosset P, Mauroy B, Bonnal JL. Urothelial Tumors and Dual-Band Imaging: A New Concept in Confocal Laser Endomicroscopy. J Endourol. 2017 May;31(5):538-544. doi: 10.1089/end.2016.0892. Epub 2017 Mar 22.

Reference Type RESULT
PMID: 28326794 (View on PubMed)

Other Identifiers

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RC-P0026

Identifier Type: -

Identifier Source: org_study_id