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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser confocal microscopy | Experimental | Patients undergoing a reno-ureteroscopy for diagnosis or treatment indication will follow a laser confocal microscopy procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Surgery duration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Louis Bonnal, MD | Groupement des Hôpitaux de l'Institut Catholique de Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupement des Hôpitaux de l'Institut Catholique de Lille | Lille | Hauts-de-France | 59000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28326794 | Result | 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. |
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| ID | Term |
|---|---|
| D006417 | Hematuria |
| D053040 | Nephrolithiasis |
| D014571 | Urologic Neoplasms |
| C537373 | Multicystic renal dysplasia, bilateral |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D018613 | Microscopy, Confocal |
| ID | Term |
|---|---|
| D008853 | Microscopy |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| 24 months |
| Reference atlas | Videos and images quality will be assessed to compile them in a refence atlas | 24 months |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007674 | Kidney Diseases |
| D052878 | Urolithiasis |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008919 |
| Investigative Techniques |