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

NCT02276924 | Completed

• 1 other identifier: RC-P0026
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Laser Confocal Microscopy; Superior Urinary Tract Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Inter- and intra-observer diagnostic concordance

  24 months

• Surgery duration

  24 months

• Reference atlas

  24 months

Study Arms (1)

Laser confocal microscopy

EXPERIMENTAL

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

Device: Laser confocal microscopy

Interventions

Laser confocal microscopy DEVICE

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.

Also known as: Cell-vizio

Laser confocal microscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (1)

Groupement des Hôpitaux de l'Institut Catholique de Lille

Lille, Hauts-de-France, 59000, France

Location

Related Publications (1)

• Marien A, Rock A, Maadarani KE, Francois C, Gosset P, Mauroy B, Bonnal JL. Urothelial Tumors and Dual-Band Imaging: A New Concept in Confocal Laser Endomicroscopy. J Endourol. 2017 May;31(5):538-544. doi: 10.1089/end.2016.0892. Epub 2017 Mar 22.

  PMID: 28326794 RESULT

MeSH Terms

Conditions

Hematuria; Nephrolithiasis; Urologic Neoplasms; Multicystic renal dysplasia, bilateral

Interventions

Microscopy, Confocal

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urolithiasis; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Jean-Louis Bonnal, MD

  Groupement des Hôpitaux de l'Institut Catholique de Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: October 28, 2014
• Study Start: October 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

FR (1)