Value of optical coherence tomography in the diagnosis of upper urinary tract urothelial carcinoma * a prospective In-Vivo human study to assess the diagnostic accuracy of optical coherence tomography for diagnosis of upper urinary tract urothelial carcinoma

Recently conservative endoscopic treatment for Upper Urinary Tract Urothelial
Carcinoma has been accepted instead of radical nefroureterectomy for patients
with low grade, low stage disease. For this reason, knowledge of tumour stage
and grade is imminent for clinical decision. Diagnostic ureteropyeloscopy
combined with histology is for now the golden standard. Unfortunately is
histology often inconclusive.
Optical Coherence Tomography is a new high resolution imaging technique which
has the potential to provide the urologist real time per-operative information
of grade and stage of the disease.

To establish in vivo sensitivity and specificity of OCT in the diagnosis of
Upper Urinary Tract Urothelial Carcinoma

This study is a prospective observational human in vivo study. Diagnostic
accuracy of OCT will be established by comparing OCT diagnosis with
pathological diagnosis, the reference standard.

Single OCT measurement of the ureter using an OCT probe which is introduced via
the worksheet of an ureteropyeloscope.

Per-operative a single OCT measurement of the ureter and/or pyelum will be
performed. After the OCT measurement, will the ureteropyeloscopy be continued
in the usual manner. An OCT 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 OCT probe is
introduced via the working channel of the ureterorenoscoop (no additional
instrumentation). OCT is based on the interaction of tissue and light and is
harmless to the patient.