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

• ClinicalTrials.gov Identifier: NCT02276924
• Recruitment Status: Completed
• First Posted: October 28, 2014
• Last Update Posted: March 21, 2019
• Sponsor: Lille Catholic University
• Information provided by (Responsible Party): Lille Catholic University

Tracking Information

• First Submitted Date: August 29, 2014
• First Posted Date: October 28, 2014
• Last Update Posted Date: March 21, 2019
• Actual Study Start Date: October 2013
• Actual Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 27, 2014)

Diagnostic relevance of laser confocal microscopy compared to the cytological and histological data, during reno-ureteroscopy according to Chang's reference criteria [ Time Frame: 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 27, 2014)

• Inter- and intra-observer diagnostic concordance [ Time Frame: 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
• Surgery duration [ Time Frame: 24 months ]
• Reference atlas [ Time Frame: 24 months ]
  Videos and images quality will be assessed to compile them in a refence atlas

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Diagnostic Relevance of Laser Confocal Microscopy for the Screening of Upper Urinary Tract Tumors
• 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
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

• Hematuria
• Nephrolithiasis
• Cancer of Urinary Tract
• Ureteropelvic Junction Obstruction

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.

Other Name: Cell-vizio

Study Arms

Experimental: Laser confocal microscopy

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

Intervention: Device: Laser confocal microscopy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 19, 2016): 29
• Original Estimated Enrollment (submitted: October 27, 2014): 30
• Actual Study Completion Date: October 2016
• Actual Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02276924
• Other Study ID Numbers: RC-P0026
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Lille Catholic University
• Study Sponsor: Lille Catholic University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jean-Louis Bonnal, MD; Groupement des Hôpitaux de l'Institut Catholique de Lille

• PRS Account: Lille Catholic University
• Verification Date: September 2016