Diagnostic Relevance of Laser Confocal Microscopy for the Screening of Upper Urinary Tract Tumors
Conditions
Hematuria, - Nephrolithiasis - Cancer of Urinary Tract - Ureteropelvic Junction Obstruction
Conditions: official terms
Nephrolithiasis - Urologic Neoplasms
Conditions: Keywords
Laser Confocal Microscopy, Superior Urinary Tract Tumors
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: Laser confocal microscopy
Type: Device
Overall Status
Recruiting
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
Groupement des Hôpitaux de l'Institut Catholique de Lille
Lille, Nord Pas-de-Calais, France
Status: Recruiting
Start Date
October 2013
Completion Date
February 2016
Sponsors
Lille Catholic University
Source
Lille Catholic University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page