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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02276924
Other study ID # RC-P0026
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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