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

Nephrolithiasis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02276924
• Other study ID #: RC-P0026
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: October 2016

Study information

• Verified date: September 2016
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Urinary Tract
• Hematuria
• Hydronephrosis
• Kidney Calculi
• Multicystic Dysplastic Kidney
• Nephrolithiasis
• Ureteral Obstruction
• Ureteropelvic Junction Obstruction
• Urologic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Groupement des Hôpitaux de l'Institut Catholique de Lille	Lille	Nord Pas-de-Calais

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Surgery duration		24 months
Secondary	Reference atlas	Videos and images quality will be assessed to compile them in a refence atlas	24 months