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

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

Sponsors

Lead sponsor: Lille Catholic University

Source Lille Catholic University
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).

Overall Status Completed
Start Date October 2013
Completion Date October 2016
Primary Completion Date October 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Diagnostic relevance of laser confocal microscopy compared to the cytological and histological data, during reno-ureteroscopy according to Chang's reference criteria 24 months
Secondary Outcome
Measure Time Frame
Inter- and intra-observer diagnostic concordance 24 months
Surgery duration 24 months
Reference atlas 24 months
Enrollment 29
Condition
Intervention

Intervention type: Device

Intervention name: Laser confocal microscopy

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.

Arm group label: Laser confocal microscopy

Other name: Cell-vizio

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Jean-Louis Bonnal, MD Principal Investigator Groupement des Hôpitaux de l'Institut Catholique de Lille
Location
facility Groupement des Hôpitaux de l'Institut Catholique de Lille
Location Countries

France

Verification Date

September 2016

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Laser confocal microscopy

Arm group type: Experimental

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

Acronym UROVISIO
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov