To establish in vivo CLE characteristics of Upper Urinary Tract Urothelial Carcinoma
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
- Ureteric disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnosis based on CLE: parameters are normal urothelium and urothelial
carcinoma
Secondary outcome
Tumor grade; low grade or high grade urothelial carcinoma
Background summary
Recently conservative endoscopic treatment for Upper Urinary Tract Urothelial
Carcinoma has been accepted instead of radical nefroureterectomy (the golden
standard) for patients with low grade, low stage disease. For this reason,
knowledge of tumour stage and grade is imminent for clinical decision.
Diagnostic ureterorenoscopy combined with histology (biopsy) is for now the
golden standard. Unfortunately histology often is inconclusive.
Confocal Laser Endomicroscopy is a new high resolution imaging technique which
has the potential to provide the urologist real time per-operative information
of the tumour-grade.
Study objective
To establish in vivo CLE characteristics of Upper Urinary Tract Urothelial
Carcinoma
Study design
This study is a prospective observational human in vivo pilot study. CLE images
will be correlated with the histopathological diagnosis and the pathological
diagnosis, the reference standard.
Study burden and risks
Per-operative a single CLE measurement will be performed after a single
intraureteral administration of fluorescein through the ureterorenoscope. After
the CLE measurement, the ureterorenoscopy will be continued in the usual
manner. An CLE measurement will take a maximum of 10 minutes. The extent of
burden for the patients is the additional time of surgery. There are no
anticipated risks for participating patients since the CLE probe is introduced
via the working channel of the ureterorenoscoop (no additional
instrumentation). The results of the CLE measurement do not have any influence
on the standard diagnostics and treatment of the patiënt.
If the presence of the preoperatively suspect tumour is not confirmed during
the diagnostic URS, no study-related activities will be performed in these
cases. This means that there is no burden related to study participation for
these patients. Standard care and pathological evaluation as stated by the
hospitals internal protocol will not be affected.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Patients >18 years
- Candidate for a diagnostic or therapeutic ureteropyeloscopy because of an upper urinary tract tumour.
- Signed informed consent
Exclusion criteria
- Patients <18 years
- Patients with known allergy for fluorescein
- Possible pregnancy or lactating women
- Patients not eligible for radical treatment of an upper urinary tract urothelial carcinoma
- No signed informed consent
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL52989.018.16 |