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

Not Applicable

Completed

• Conditions: Hematuria; Nephrolithiasis; Cancer of Urinary Tract; Ureteropelvic Junction Obstruction
• Interventions: Device: Laser confocal microscopy

• Registration Number: NCT02276924
• Lead Sponsor: 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).

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-08-29
• Study First Submitted QC: 2014-10-27
• Study First Posted: 2014-10-28
• Status Verified: 2016-09
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Diagnostic relevance of laser confocal microscopy compared to the cytological and histological data, during reno-ureteroscopy according to Chang's reference criteria	24 months	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

Name	Time	Method
Surgery duration	24 months
Reference atlas	24 months	Videos and images quality will be assessed to compile them in a refence atlas
Inter- and intra-observer diagnostic concordance	24 months	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

Trial Locations

Locations (1)

Groupement des Hôpitaux de l'Institut Catholique de Lille; 🇫🇷 Lille, Nord Pas-de-Calais, France