Prospective evaluation of the RT-PCR based urinary marker Bladder Epicheck® as a diagnostic tool in upper urinary tract tumor.

BACKGROUND: Upper-tract-urothelial-carcinoma (UTUC) represents 5-10% of all urothelial-neoplasms with increasing incidence in the last decades. Current standard tools for diagnosis of UTUC include cytology, computed tomography (CT) urography and ureterorenoscopy (URS). The aim of this study was to evaluate the impact of Bladder Epicheck® Test as diagnostic tool for UTUC diagnosis and recurrence. METHODS: Overall, 136 urine samples, selective collected from upper-urinary-tract before URS for suspicion of UTUC were analyzed with cytology and Bladder Epicheck® Test. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of both markers were calculated and compared to URS and/or histology as reference. RESULTS: UTUC was detected in 40 cases (33.3%), among them 30 were classified as low-grade (LG) and 10 as high-grade (HG). Overall sensitivity of Bladder Epicheck® for UTUC detection was 65% compared to 42.5% for cytology, increasing to 100% for Bladder Epicheck® and 90% for cytology if considering only HG tumors. Overall specificity of Bladder Epicheck® was 81.2% and of cytology 93.7%. PPV and NPV were 63.4% and 82.2% for Bladder Epicheck® and 77.2% and 76.5% for cytology. Considering an EpiScore cut-off >75, instead of 60, specificity of Bladder Epicheck® improves to 89% and PPV to 74.2%. Limitations include the use of a marker validated only for bladder-cancer and the relatively small number of cases. CONCLUSIONS: Due to its high sensitivity for HG tumors, the Bladder Epicheck® Test can be used in diagnosis and treatment decision-making of UTUC. Furthermore, it could be very useful in follow-up of UTUC, after endoscopic treatment to postpone or avoid unnecessary endoscopic exploration. Even if further studies are needed to validate these findings, Bladder Epicheck® could be a promising clinical tool for detection of UTUC.

Treatment of long ureteric strictures with a free peritoneal graft: long-term results.

ZIEL DER STUDIE: Beschreibung einer neuen Technik zur Rekonstruktion von komplexen Ureterstrikturen unter Verwendung eines freien Peritoneallappens. MATERIAL UND METHODEN: Zwischen 2006 und 2021 behandelten wir 11 Patienten mit langen komplexen Harnleiterstrikturen, die in 9 Fällen den mittleren- und in 2 Fällen den proximalen Harnleiter betrafen. Die Länge der Strikturen variierte von 3 bis 12 cm (Mittelwert 7 cm). In drei Fällen handelte es sich um eine retroperitoneale Fibrose nach einem gefäßchirurgischen Eingriff, in zwei Fällen um einen Morbus Ormond, in vier Fällen um eine ausgedehnte Resektion großer Harnleitertumoren, in drei Fällen um wiederholte endoskopische Eingriffe bei Harnsteinen und in einem Fall um eine viermal fehlgeschlagene Pyeloplastik. Der Harnleiter wurde längs gespalten, ein freier Peritoneallappen aus dem nahe gelegenen gesunden Bauchfell entnommen und nach Positionierung eines Harnleiterkatheters als Onlay-Patch mit einer fortlaufenden Naht an der verbleibenden Harnleiterplatte fixiert. Der Ureter wurde zuletzt mit Omentum gedeckt. ERGEBNISSE: Die Nachbeobachtungszeit reichte von 12 bis 122 (Mittelwert 61,6) Monate. Sieben Patienten waren nach 12, 18, 60, 78, 98, 99 und 122 Monaten (Mittelwert 69,5 Monate) rezidivfrei, ohne Erweiterung des oberen Harntrakts und mit normaler Nierenfunktion. Bei vier Patienten kam es zu einem Rezidiv: Bei einem Patienten wurde das Rezidiv nach 60 Monaten ohne Symptome und mit leichter Hydronephrose festgestellt, ohne dass eine Operation erforderlich war. Bei einem Patienten mit Morbus Ormond trat das Rezidiv 6 Monate nach dem Eingriff symptomlos im distalen Teil des 10 cm langen Omlays auf. Es wurde eine Resektion des stenotischen Segments mit Psoas-Hitch durchgeführt. Bei den beiden anderen Patienten trat 3 und 6 Monate nach dem Eingriff eine Obstruktion unterhalb des rekonstruierten Segments mit Hydronephrose auf, ohne dass die Nierenfunktion beeinträchtigt war. Bei diesen Patienten wurde keine weitere Operation durchgeführt. Die Limitation dieser Studie besteht in der kleinen Studiengröße, die auf die strenge Indikationsstellung zurückzuführen ist. SCHLUSSFOLGERUNGEN: Die beschriebene Technik ermöglicht den Erhalt der verbleibenden Gefäßversorgung des Harnleiters und stellt eine praktikable und nützliche Alternative zu Nephrektomie, Ileum-Ureter, Uretero-Uretero-Stomie und Autotransplantation in hochselektierten Fällen dar.

Diagnostic value of Xpert® BC Detection, Bladder Epicheck®, Urovysion® FISH and cytology in the detection of upper urinary tract urothelial carcinoma.

PURPOSE: Following the current guidelines, diagnosis and staging for upper urinary tract tumours (UTUC) can be performed with Computed Tomography, urography, ureterorenoscopy (URS) and selective cytology. The aim of the study was to evaluate the performance of the Xpert®-BC-Detection and the Bladder-Epicheck®-test in the detection of UTUC and compare it with cytology and the Urovysion®-FISH test using histology and URS as gold standard. METHODS: A total of 97 analyses were collected through selective catheterization of the ureter before URS to test for cytology, Xpert®-BC-Detection, Bladder-Epicheck® and Urovysion®-FISH. Sensitivity, specificity, and predictive values were calculated using histology results/URS as reference. RESULTS: Overall sensitivity was 100% for Xpert®-BC-Detection, 41.9% for cytology, 64.5% for Bladder-Epicheck® and 87.1% for Urovysion®-FISH. The sensitivity of Xpert®-BC-Detection was 100% in both, LG and HG tumours, sensitivity of cytology increased from 30.8% in LG to 100% in HG, for Bladder-Epicheck® from 57.7% in LG to 100% in HG and of Urovysion®-FISH from 84.6% in LG to 100% in HG tumours. Specificity was 4.5% for Xpert®-BC-Detection, 93.9% for cytology, 78.8% for Bladder-Epicheck® and 81.8% for Urovysion®-FISH. PPV was 33% for Xpert®-BC-Detection, 76.5% for cytology, 58.8% for Bladder-Epicheck® and 69.2% for Urovysion®FISH. NPV was 100% for Xpert®-BC-Detection, 77.5% for cytology, 82.5% for Bladder-Epicheck® and 93.1% for Urovysion®FISH. CONCLUSION: Bladder-Epicheck® and Urovysion®FISH along with cytology could be a helpful ancillary method in the diagnosis and follow-up of UTUC while due to its low specificity Xpert®-BC Detection seems to be of limited usefulness.

Evaluation of the M371-Test Under Real-life Conditions for Diagnosis and Follow Up of Testicular Germ Cell Tumors.

BACKGROUND/AIM: The aim of the study was to establish the performance of the M371-Test on the Thermocycler Rotor-GeneQ (Qiagen) platform for diagnosis and follow-up of testicular tumors and to evaluate the test under real-life conditions in comparison to the classical markers alpha-fetoprotein (AFP), beta-human chorionic gonadotropin (ß-HCG) and lactate dehydrogenase (LDH). PATIENTS AND METHODS: Forty-four patients, of median age 29 years (range=24-84) were included in this prospective study at our institution between March 2021 and September 2022. Of the 44 patients, 23 had a suspicion of testicular cancer (TC) and 21 were under follow-up for TC. In total, 96 M371-Tests were performed and compared with AFP, ß-HCG, LDH using histological diagnosis and/or computer tomography (CT) scan as the gold standard. RESULTS: In the patients with suspicion of TC, the M371-Test showed a sensitivity of 73.7%, AFP of 21%, LDH of 31.6% and ß-HCG of 42.1%. In the patients under follow-up for TC, the M371-Test showed a sensitivity of 86.4%, AFP of 50%, LDH of 31.8% and ß-HCG of 63.6%. In germ cell tumours (GCT)/non-seminomas, M371-Test had a sensitivity of 83.3%, AFP of 77.8%, LDH of 38.9% and ß-HCG of 66.7%. In GCT/seminomas, M371-Test had a sensitivity of 85%, AFP of 5%, LDH of 30% and ß-HCG of 50%. CONCLUSION: Under real life conditions performed on the real-time Thermocycler Rotor-GeneQ (Qiagen) platform, the M371-Test shows an outstanding performance and is far beyond the sensitivity of the classical markers for detecting GCTs and in the follow-up of patients after GCT, especially in seminomas.

Xpert® bladder cancer detection as a diagnostic tool in upper urinary tract urothelial carcinoma: preliminary results.

Objectives: Upper urinary tract urothelial carcinoma (UTUC) represents about 5-10% of all urothelial malignancies with an increasing incidence. The standard diagnostic tools for the detection of UTUC are cytology, computed tomography (CT) urography, and ureterorenoscopy (URS). No biomarker to be included in the daily clinical practice has yet been identified. The aim of our study was to evaluate the potential role of Xpert® Bladder-Cancer (BC)-Detection in the diagnosis of UTUC. Methods: Eighty-two patients underwent 111 URS with Xpert® BC-Detection, cytology, or Urovysion® analysis of UT for suspicion of UTUC. Twenty-four cases were excluded from the analysis due to a non-diagnostic Xpert® BC-Detection, cytology, or Urovysion®. Samples were analyzed with upper tract (UT) urinary cytology, with Xpert® BC-Detection on UT urines, and with Urovysion® Fluorescence in situ hybridization (FISH) test. After urine collection, the patients underwent retrograde pyelography and/or URS, and if positive a UT biopsy. The Xpert® BC-Detection was reported by the software as negative or positive [cut-off total Linear Discriminant Analysis (LDA) = 0.45]. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of cytology, Xpert® BC-Detection and Urovysion-FISH were calculated using URS and/or histology results as reference. Results: In all, 27 (31%) of 87 URS resulted positive, with 20 low-grade (LG) and 7 high-grade (HG) tumors. Overall sensitivity was 51.9% for cytology, 100% for Xpert® BC-Detection, and 92.6% for Urovysion. The sensitivity of cytology increased from 26% in LG to 100% in HG tumors. For Xpert® BC-Detection, sensitivity was 100% both in LG and in HG, and for Urovysion-FISH, it increased from 90% in LG to 100% in HG tumors. PPV was 82.4% for cytology, 35% for Xpert® BC-Detection, and 73.5% for Urovysion. NPV was 81.4% for cytology, 100% for Xpert® BC-Detection, and 96.2% for Urovysion. Conclusion: The excellent NPV of Xpert® BC-Detection allows to avoid unnecessary endoscopic exploration of the UT, reducing invasiveness and URS complications in the follow-up of UTUC.