Advances in Urological Diagnosis and Imaging - AUDI (Vol. 6 - n. 1 - 2023)

ADVANCES IN UROLOGICAL DIAGNOSIS AND IMAGING

EDITOR IN CHIEF

Andrea B. Galosi CO-EDITOR

Pasquale Martino

S.I.E.U.N.

OFFICIAL JOURNAL of Italian Society of Integrated Diagnostic in Urology, Andrology, Nephrology

A DVANCES IN U ROLOGICAL D IAGNOSIS AND I MAGING

Official Journal of S.I.E.U.N.

EDITOR in CHIEF

Andrea B. Galosi, Ancona (IT)

CO-EDITOR

Pasquale Martino, Bari (IT)

ASSISTANT EDITOR

Lucio Dell’Atti, Ancona (IT)

JUNIOR ASSISTANT EDITOR

Carlo Giulioni, Ancona (IT)

EDITOR

Luigi Napolitano, Napoli (IT)

EDITORIAL BOARD

Urology

Ahmed Hashim, London (GB), Artibani Walter, Verona (IT) Battaglia Michele, Bari (IT), Bucci Stefano, Trieste (IT)

Carini Marco, Firenze (IT), Carrieri Giuseppe, Foggia (IT)

De Nunzio Cosimo, Roma (IT), Fandella Andrea, Treviso (IT)

Ficarra Vincenzo, Messina (IT), Finazzi Agrò Enrico, Roma (IT)

Franzese Corrado, Nola (IT), Gunelli Roberta, Forlì (IT)

Kastner Christof, Cambridge (GB), Lapini Alberto, Firenze (IT)

Miano Roberto, Roma (IT), Mirone Vincenzo, Napoli (IT)

Montorsi Francesco, Milano (IT), Morgia Giuseppe, Catania (IT)

Muller Stefan, Bonn (GE), Palazzo Silvano, Bari (IT)

Pavlovich Christian, Baltimore, Maryland (USA)

Pepe Pietro, Catania (IT), Rocco Bernardo, Modena (IT)

Salomon George, Hamburg (GE)

Schiavina Riccardo, Bologna (IT), Scattoni Vincenzo, Milano (IT)

Volpe Alessandro, Novara (IT), Waltz Joachen, Marseille (FR)

Andrology

Bettocchi Carlo, Bari (IT), Bitelli Marco, Roma (IT)

Cai Tommaso, Trento (IT), Cormio Luigi, Foggia (IT)

Fusco Ferdinando, Napoli (IT), Gontero Paolo, Torino (IT)

Liguori Giovanni, Trieste (IT), Lotti Francesco, Firenze (IT)

Pizzocaro Alessandro, Milano (IT), Trombetta Carlo, Trieste (IT)

Nephrology

Boscutti Giuliano, Trieste (IT), D’Amelio Alessandro, Lecce (IT)

Fiorini Fulvio, Rovigo (IT), Gesualdo Loreto, Bari (IT)

Granata Antonio, Agrigento (IT), Ranghino Andrea, Ancona (IT)

Radiology

Barozzi Libero, Bologna (IT), Bertolotto Michele, Trieste (IT)

Giuseppetti Gian Marco, Ancona (IT)

Giovagnoni Andrea, Ancona (IT), Valentino Massimo, Tolmezzo (IT)

Pathology

Beltran Antonio Lopez, Lisbon (PT), Fiorentino Michelangelo, Bologna (IT)

Liang Cheng, Indianapolis (USA), Montironi Rodolfo, Ancona (IT)

Bio-Medical Engineering

Wijkstra Hessel, Eindhoven (NL)

General Information

AIMS and SCOPE

“Advances in Urological Diagnosis and Imaging” (AUDI) has the purpose of promoting, sharing and favorite technical-scientific research on echography and imaging diagnosis, in diagnostic and terapeutical field of Urology, Andrology and Nefrology. AUDI publishes original articles, reviews, case reports, position papers, guidelines, editorials, abstracts and meeting proceedings.

AUDI is Open Access at www.issuu.com

Why Open Access? Because it shares science at your finger tips with no payment. It is a new approach to medical literature, offering accessible information to all readers, becoming a fundamental tool, improving innovation, efficiency and interaction among scientists.

COPYRIGHT

Papers are accepted for publication with the understanding that no substantial part has been, or will be published elsewhere. By submitting a manuscript, the authors agree that the copyright is transferred to the publisher if and when the article is accepted for publication. The copyright covers the exclusive rights to reproduce and distribute the article, including reprints, photographic reproduction and translation. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior written permission of the Publisher.

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Contents

1 Abstracts

XXIII - S.I.E.U.N. NATIONAL CONGRESS

7 Granulomatous prostatitis, a very critical diagnosis

Giovanni Maria Fusco, Luigi Cirillo, Ernesto Di Mauro, Roberto La Rocca, Luigi Napolitano

9 Prostate fusion biopsy: cost analysis in 2022 for transrectal and transperineal prostate biopsies under local anesthesia

Andrea Fandella, Stefano Guazzieri, Gaetano Loiero

Edizioni Scripta Manent s.n.c.

Via Melchiorre Gioia 41/A - 20124 Milano, Italy

Tel. +39 0270608060

Registrazione: Tribunale di Milano n. 19 del 17/01/2018

e-mail: info@edizioniscriptamanent.eu web: www.edizioniscriptamanent.it

Direttore Responsabile: Pietro Cazzola

Direzione Marketing e PR: Donatella Tedeschi

Comunicazione e Media: Ruben Cazzola

Grafica e Impaginazione: Cinzia Levati, Maria Isola

Affari Legali: Avv. Loredana Talia (MI)

S.I.E.U.N.: the future starts today

Lucio Dell’Atti

Consigliere SIEUN – Dirigente SOSD Qualità, Rischio Clinico, Innovazione Gestionale e Tecnologica, Azienda Ospedaliero Universitaria delle Marche, Ancona.

Il 3, 4 e 5 Novembre 2022 si è svolto nell’elegante cornice della barocca città di Lecce il 23° Congresso Nazionale della Società Italiana di Diagnostica Integrata in Urologia, Andrologia e Nefrologia (SIEUN), Presidenti ed organizzatori del congresso Dr. Alessandro D’Amelio e Silvano Palazzo. Durante le giornate del congresso, che hanno visto l’avvicendarsi di una serie di dibattiti strutturati e tavole rotonde, grazie alla partecipazione di una nutrita faculty di una caratura nazionale ed internazionale, si sono trattati ed approfonditi svariati topics quali la diagnostica integrata nella patologia neoplastica del rene, la biopsia prostatica nell’epoca della risonanza magnetica multiparametrica, il ruolo della Pet-PSMA nel carcinoma prostatico, lo stato dell’arte dell’ecografia in Nefrologia, oltre che a contributi di importanti società scientifiche italiane quali SIU, SIA, Auro, SIN e SIUT.

Particolare menzione meritano la lettura SIU del Prof. Giuseppe Carrieri sulla diffusione, funzionamento e problematiche dei team multidisciplinari uro-oncologici in Italia e la lettura ESUI (sezione di Imaging urologico della società Europea di Urologia) tenuta dal Prof. Pasquale Martino sulla radiomica ed intelligenza artificiale quali nuove frontiere nella diagnostica per immagini.

Durante la prima giornata congressuale si è svolto il primo corso italiano accreditato di “ecografia infermieristica” rivolto

alle professioni sanitarie che ha visto la partecipazione di un cospicuo numero di partecipanti, provenienti da diverse realtà ospedaliere d’Italia, cimentarsi con esercitazioni pratiche su ecografo e successivo test di apprendimento.

La seduta amministrativa svoltasi durante la seconda giornata congressuale ha varato dopo regolare consultazione elettorale la nomina del nuovo presidente il Prof. Pasquale Martino, che succede alla guida societaria al Prof. Andrea Galosi, e l’insediamento del nuovo Consiglio Direttivo, Comitato Scientifico societario e nuova delegazione regionale (Figura 1).

L’ultima giornata congressuale ha visto la realizzazione di un corso avanzato di video didattica di ecografia uronefro-andrologica che ha messo in rilievo i tips and tricks da impiegare nella pratica clinica quotidiana. Il corso di video didattica ha visto la singolare partecipazione di due classi scolastiche del 5° anno del Liceo Classico Palmieri di Lecce accompagnate dai rispettivi docenti e tutor, questo a sottolineare come la SIEUN ha una mission ed uno sguardo rivolto verso il futuro ed i giovani medici che saranno i principali attori di esso (Figura 2).

In questo numero speciale di AUDI sono riportati i principali contributi scientifici con le tematiche presentate durante le sessioni abstracts dedicate nel corso delle giornate congressuali.

ABSTRACTS - S.I.E.U.N. NATIONAL CONGRESS

XXIII CONGRESSO NAZIONALE SIEUN Abstracts

FIRST EXPERIENCE TO CERTIFY THE PDTA PROCESSES WITH THE REQUIREMENTS DEFINED BY ISO 22301:2019 IN EMERGENCY DIAGNOSTIC IMAGING

4

Introduction. The Business Continuity Plan (BCP) is an alternative security plan that a company must have to continue its operations in the event of catastrophic events due to natural or man-made events that can undermine integrity (1).These unexpected events of external or internal origin must be prevented by creating a plan for operational continuity of care. Suppose risk management has been done in a reasoned manner through a Business Impact Analysis (BIA) according to ISO 22301:2019 certification (2). This study describes our experience promoting a healthcare company model structured according to Diagnostic-Therapeutic-Assistance Pathways (PDTA) processes and business continuity ISO 22301 in medical emergency services and emergency diagnostic imaging. Materials and Methods. This project was formulated by the Unit of Quality and Risk Management. The Business Continuity Team features all the professional figures responsible for the various hospital sectors of interest. The methodology adopted in this study for analyzing the impact on operations and risk assessment provides for the execution of a RISK Assessment through software. This software is planned to formulate a BIA relating to the failure modes (disruptions) correlated to the PDTA considered "critical" for an interruption of business continuity. The mentioned team identifies the Crisis scenarios and, for each of them, the sub-scenarios (failure modes) that can create problems for the operational continuity of the PDTAs involved in the analysis. The team identifies 4 scenarios and 32 sub-scenarios (Table 1). The Team, through a brainstorming activity and previous experiences, evaluates the VULNERABILITY of each PDTA concerning each single failure mode defined in Table 1. Having calculated the vulnerability indicator for each of the PDTAs, the work team calculated the Impact index: IMPACT INDEX = force of law + reputation + service disruption. once the level of vulnerability and the impact of each PDTA have been defined, the level of risk was defined, intended as a

Scenario 1 - Hospital Disaster Management of IT Services:

GDPR

Storage device failures

Loss of paper archives

Backup failure

Health data stolen

Health data lost or unavailable

Failure/damage of external telephone network

Faults/damage to the internal telephone network

Corporate hardware failures

Switchboard faults

WIRED NETWORK faults

Mobile phone network failures

Errors in Software Applications

Scenario 2 - Lack of infrastructure: Contamination

Electricity outage

Medical gas interruption

Water outage

Electromedical failure

Heating/cooling fault

Fire

Earthquake

Flooding

Scenario 3 - HR shortage:

Shortage due to a sudden increase in demand

Shortage due to pandemic and epidemic

Unavailability on the reference market

Organizational unavailability

Unavailability due to competence

Public transport disruption

Scenario 4 – Supplies:

Defects in the quality of supplies

Failure to supply

Contractual breach

Supply chain disruption

Dell’Atti L1, Papa R1, Incicchitti L2, Zanni K2, Zampa A3, Caporossi M4.

1 Unit of Quality and Risk Management, University-Hospital of Marche, Ancona (Italy);

2 Healthcare Medical Direction, University-Hospital of Marche, Ancona (Italy);

3 Consultek Group s.r.l, Fano, (Italy);

General Director, University-Hospital of Marche, Ancona (Italy).

Table 1. The identified scenarios and related failure modes.

ABSTRACT – XXIII CONGRESSO NAZIONALE SOCIETÀ ITALIANA DI DIAGNOSTICA

measure of a system's exposure to threats.

RISK LEVEL (LR) score = vulnerability index X the impact index. The Team evaluates for the CRITICAL PDTA (STEMI, TRAUMA and STROKE) which failure modes are risky and which require or develop a BCP.

Results. An external body conducted an inspection visit last September, verifying the Company's ability to react and respond to emergency scenarios. They evaluated the compliance and adherence to the international standard's requirements. Our University Hospital of Marches has been working according to the BCP criteria since October 2022. It is the first company in the world to certify the PDTA processes for business continuity ISO 22301:2019. This certification project envisaged a planning process which lasted approximately 12 months. This process included the identification of suitable PDTAs for a BCP through an accurate BIA process (1 month), the creation of structural procedures (23 procedures in 3 months), the redefinition and updating of the PDTAs in the light of the business continuity plan (3 months), the preparation of exercises aimed at guaranteeing and satisfying operational continuity and assistance objectives (3 months) and finally the awareness and training of our stakeholders regarding its correct application (2 months). Exercises and testing have been instrumental in ensuring that the strategies, policies, plans and procedures are adequate to meet business continuity objectives (3).

Conclusion. Every single disruption in a Healthcare Company will produce direct economic damages closely linked to its structure and resources, but also indirect ones, i.e. more closely linked to patients who do not use the healthcare services provided by the structure itself. Using ISO 22301 and a structured corporate BCP program through an accurate BIA process will undoubtedly promote economic savings to healthcare facilities by promoting operational continuity for critical assets for the provision of their services, including goods and services stock-up.

References.

1. Capparelli J, Chionna G, Riglietti G. What makes for effective business continuity implementation? J Bus Contin Emer Plan. 2022; 15(4):302-311.

2. Zawada B. The practical application of ISO 22301. J Bus Contin Emer Plan. 2014; 8(1):83-90.

3. Sever MS, Remuzzi G, Vanholder R. Disaster medicine and response: Optimizing life-saving potential. Am J Disaster Med. 2018; 13(4):253-264.

Traunero F18, Montanari E19, Boeri L19, Maggi M20, Del Giudice F20, Bove P21, Forte V21, Ficarra V22, Alario G22, Gilante M22, Pagliarulo E23, Tafuri A23, Mirone V15, Schips L13, Antonelli A9, Gontero P10, Cormio L1,24, Sciarra A20, Porpiglia F8, Bassi P6, Di Tonno P7, Boström PJ12, De Cobelli O3, Messina E25, Panebianco V25, Carrieri G1.

1 Department of Urology and organ transplantation, university of Foggia, Foggia, Italy;

2 Department of Urology, Karolinska University Hospital Solna, Sweden;

3 Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden;

4 Department of Radiology, University of Turku, Turku, Finland; Medical Imaging Centre of Southwest Finland, Turku University Hospital, Turku, Finland;

5 Urologic cancer surgery department, Istituto Europeo di Oncologia, Milano, Italy;

6 Department of Urology, Catholic University Medical School "A. Gemelli" Hospital, Rome, Italy;

7 Department of Urology, Andrology and Kidney Transplantation, University of Bari, Bari, Italy;

8 Department of Urology, Azienda Ospedaliera Universitaria “San Luigi Gonzaga”, University of Turin, Turin, Italy;

9 Azienda Ospedaliera Universitaria Integrata di Verona, UOC Urologia;

10 Dept of Surgical Sciences, Citta della Salute e della Scienza di Torino, Molinette Hospital, Turin, Italy;

11 Institute of Biomedicine, University of Turku and Department of Pathology, Turku University Hospital, Turku, Finland;

12 Department of Urology, University of Turku and Turku University hospital, Turku, Finland;

13 Department of Urology, Universita "G.d'Annunzio", ChietiPescara, Italy;

14 Department of oncologic Urology, "Regina Elena" National Cancer Institute, Rome, Italy;

15 Department of Urology, University of Naples Federico II, Naples, Italy;

16 IRCCS Policlinico San Donato, Milan, Italy;

17 Department of Urology, Ente Ecclesiastico Miulli, Acquaviva delle Fonti, Italy;

18 Clinica Urologica di Trieste, Trieste, Italy;

19 Department of Urology, IRCCS Foundation Ca' GrandaMaggiore Policlinico Hospital, Milan, Italy;

20 Department of Maternal Infant and Urological Sciences, Sapienza Rome University, Rome, Italy;

21 Department of Urology, San Carlo di Nancy Hospital, Rome, Italy;

22 Department of Urology, University of Messina, Messina, Italy;

23 Department of Urology, Vito Fazzi Hospital, Lecce, Italy;

24 Department of Urology, Ospedale L. Bonomo, Andria, Italy;

DIAGNOSIS

OF PROSTATE CANCER WITH MULTIPARAMETRIC MRI IN MEN TREATED WITH 5-ALPHAREDUCTASE INHIBITORS: RESULTS OF A MULTICENTER INTERNATIONAL COLLABORATION

Falagario UG1,2, Lantz A2,3, Jambor I4, Busetto GM1, Bettocchi C1, Luzzago S5, Ferro M5, Totaro A6, Racioppi M6, Carbonara U7, Manfredi M8, Daietti D9, Porcaro A9, Nordström T3, Bjornebo L3, Ordeda M10, Soria F10, Taimen P11, Aronen HJ4, Perez IM4, Ettala O12, Marchioni M13, Simone G14, Ferrero M14, Brassetti A14, Napolitano L15, Carmignani L16, Ludovico G17, Scarcia M17, Trombetta C18, Claps F18,

25 Department of Radiological Sciences, Oncology and Pathology, Sapienza University/Policlinico Umberto I, Rome, Italy.

Introduction and Objective. 5-alpha reductase inhibitors (5-ARIs) are widely used for treatment of patients with bladder outlet obstruction symptoms. The aim of this study was to evaluate accuracy of Magnetic Resonance imaging (MRI) of the prostate for the diagnosis of clinically significant Prostate Cancer (csPCa) in men treated with 5-ARIs.

Methods. Retrospective analysis of an international database (PROMOD) including data of patients undergoing prostate biopsy with a pre-biopsy MRI in 24 European

institutions. Patients treated with 5-ARIs for at least three months at the time of MRI were included in the study group while 5-ARIs naïve patients were used as controls. Outcome of the study was csPCa defined as Biopsy Gleason Grade (GG) ≥2. Negative (NPV) and positive (PPV) predictive values were used to assess the accuracy of MRI in predicting the outcome of interest. Results. 7346 patients were eligible for the present study. 696 patients were treated with 5-ARIs. They were older (66 vs 70), had lower PSA values (6.7 vs 6.3, p 0.001) and larger prostate volumes (49 vs 54, p<0.0001). Prostate MRI showed PIRADS 3, 4 and 5 lesions in 25, 42 and 21% of the patients in the control group and 22, 36 and 23% of the patients in the 5-ARI’s group (p <0.0001). Central zone and transition zone lesions were more frequent in the 5-ARI’s group. There was no difference in csPCa (GG≥2) detection rates (41% vs 40%, p 0.8), however detection of GG 1 PCa was higher in the control group (18% vs 15%) and the detection of high Grade PCa (GG≥3) was significantly higher in patients treated with 5ARI’s (20% vs 24%, p 0.019). At multivariable logistic regression analysis, treatment with 5-ARI’s was found to be correlated with diagnosis of high Grade PCa (GG≥3). The accuracy of mpMRI was similar in the two groups with no difference in PPV, NPV and detection rates by PIRADS score.

Conclusion. MpMRI proved to have similar diagnostic accuracy for prebiopsy risk stratification both in patients who underwent treatment with 5-ARIs and who did not. Moreover, a higher rate of high grade PCa was detected in patients treated with 5-ARIs, and most of them were clearly visible on MRI and classified as PIRADS 4 and 5 lesions. Finally, in contrast to serum PSA values, PSA density and MRI are not affected by treatment with 5-ARIs and should be considered the first tools for the decision whether to proceed to prostate biopsy.

APPROCCIO CONSERVATIVO NEL

TRATTAMENTO DELLE PICCOLE MASSE DEL RENE TRAPIANTATO: ESPERIENZA PRELIMINARE CON CRIOABLAZIONE

Lospalluto M, Spilotros M, Palella G, Dell’Atti C, Selvaggio O, Soldano S, Matera M, Miacola C, Tedeschi M, Lucarelli G, Battaglia M, Ditonno P.

Dipartimento dell’Emergenza e dei Trapianti d’Organo- Unità di Urologia, Andrologia e Trapianto di Rene. Università degli Studi di Bari.

Le tecniche ablative focali per il trattamento mini-invasivo delle piccole masse renali rappresenta un campo in continua evoluzione ed applicabile per lesioni inferiori ai 4 cm (T1a) in particolar modo in pazienti che presentano comorbidità e per questo motivo non idonei a trattamento chirurgico, pazienti anziani o monorene. La diagnosi di neoplasie del rene trapiantato rappresenta una sfida terapeutica principalmente perché una eventuale nefrectomia parziale potrebbe causare una significativa perdita di massa nefronica sana. Il trattamento con crioablazione, tecnica capace di determinare la distruzione della lesione tramite congelamento delle cellule tumorali, in questi pazi-

enti rappresenta un approccio possibile per salvaguardare il tessuto sano trattando la massa tumorale. La crioablazione si avvale dell’utilizzo di criosonde ad argon capaci di generare una temperatura target pari o inferiore a -40°. L’evidenza scientifica a supporto di questo approccio in particolare in pazienti trapiantati di rene resta tuttavia scarsa e basata su studi di qualità limitata. Descriviamo la nostra esperienza preliminare del trattamento mediante questa metodica di una lesione cistica complessa del terzo medio posteriore del rene trapiantato in fossa iliaca destra in paziente maschio di 49 anni per cui il trattamento chirurgico risultava non idoneo. La procedura, TC-guidata per la verifica del corretto posizionamento delle sonde, si è basata su due cicli di congelamento (10 min) e riscaldamento (5 min) per una durata totale di 50 minuti in anestesia locale e sedazione. Al termine è stata documentata mediante TC la formazione di una “iceball” estesa per 5-10 mm oltre il limite della lesione target e non sono state registrate complicanze peri e post-operatorie. In base a questa preliminare esperienza il trattamento con crioablazione delle neoplasie del rene trapiantato rappresenta un’opzione terapeutica sicura in pazienti selezionati sebbene per quanto riguarda le conclusioni sugli outcome oncologici necessitiamo di numeri maggiori di pazienti trattati e follow-up significativi.

EFFICACIA E SICUREZZA DELLA BIOPSIA PERCUTANEA ECOGUIDATA DEL RENE NATIVO. CASE SERIES MONOCENTRICA

Zito A, Fontò G, Protopapa P, Napoli M De Pascalis A.

Introduzione. La biopsia renale percutanea (BRP) dei reni nativi rappresenta uno strumento fondamentale per la diagnosi e la gestione delle malattie renali. L’adozione della guida ecografica e la disponibilità di procedure interventistiche ha consentito di ridurre drasticamente l’incidenza delle complicanze.

La gravità delle complicanze è classificata in maggiore (emorragia incoercibile con necessità di trasfusione di sangue e/o procedura radiologica o chirurgica invasiva; fistola artero-venosa che richiede procedura radiologica invasiva; ipotensione grave da anemizzazione severa; ostruzione renale acuta; insufficienza renale; sepsi; Page kidney; morte) e minore (dolore al fianco severo; calo dell’ematocrito che non necessita di emotrasfusione; ematuria macroscopica; ematoma perinefrico subcapsulare che si risolve spontaneamente; fistola artero-venosa a risoluzione spontanea). In questo studio, abbiamo analizzato efficacia e sicurezza delle PRB nel nostro centro.

Materiali e metodi. Sono state considerate tutte le BRP consecutive effettuate nella nostra Unità Operativa di Nefrologia, Dialisi e Trapianto nel periodo dal 1/01/2018 al 33/09/2022. Si è riportato il numero e il tipo di complicanze e le diagnosi riscontrate.

La popolazione biopsiata ha presentato queste manifestazioni cliniche: anomalie urinarie, sindrome nefrosica, insufficienza renale acuta. Le BRP sono state eseguite in regime di ricovero previo consenso informato e sotto

UOC Nefrologia, Dialisi e Trapianto, ASL Lecce, Ospedale Vito Fazzi.

– XXIII CONGRESSO

costante guida ecografica. La procedura ha previsto lo studio accurato dei parametri emocoagulativi, la somministrazione preventiva di desmopressina e l’anestesia locale. Sono stati effettuati 1-3 affondamenti al polo inferiore del rene sinistro per il prelievo di una quantità congrua di tessuto renale con ago semiautomatico 15 o 17 G, in anestesia locale. I campioni sono stati conservati e inviati presso il Laboratorio di Istopatologia Renale del Policlinico di Bari per lo studio in microscopia ottica, immunofluorescenza e microscopia elettronica ove indicato. Il tempo di osservazione del paziente dopo biopsia renale è stato di almeno 24 ore.

Risultati. Nel periodo considerato sono state effettuate 100 BRP, con una media annuale di 20 procedure. Si sono registrate 23 complicanze, delle quali 1 maggiore e 22 minore (Tabella 1). Nel complesso, il tasso di complicanze era del 23%, di cui 95% minori e il 5% maggiori. Le diagnosi ottenute sono indicate in Tabella 2, Figura 1.

Figura 1.

L’unica complicanza maggiore è stata un’emorragia incoercibile che ha richiesto multiple trasfusioni di emocomponenti e una procedura in urgenza di radiologia interventistica. Non sono stati osservati decessi o nefrectomie dopo BRP.

Fra le complicanze minori, si sono verificati 15 casi di ematomi subcapsulari (15%), 2 fistole artero-venose di piccole dimensioni e a risoluzione spontanea e 5 episodi di macroematuria in altrettanti pazienti (15%). Osservazione e riposo per le 24-36 ore seguenti hanno permesso la remissione del quadro.

Conclusioni. La nostra casistica di complicanze è in linea con le serie europee e americane, che hanno descritto complicanze minori nel 10-20% e maggiori nell’1,2–6,6% dei pazienti. La continua guida ecografica e l’esperienza degli operatori, ottenuta centralizzando le BRP in una struttura con disponibilità immediata di procedure interventistiche, ha consentito di ridurre drasticamente il tasso di complicanze, in particolare di quelle maggiori. La BRP si conferma procedura efficace e sicura, anche sotto il profilo medico-legale, quando effettuata secondo precisa indicazione clinica e dopo attenta valutazione del rapporto rischi/benefici.

Letture consigliate.

- Kisrani A, KasiskeB. Laboratory assessment of kidney disease: clearance, urinalysis and kidneybiopsy In The Kidney, Brenner and Rector Editors, Saunders Company Philadelphia. 2008; (1)23:747-756.

- Whitter W, Korbes S. Indications and complications of renal biopsy UpToDate 2022 www. UpToDate.com

- Fuiano G, Mazza G, Comi N, et al. Current indications for renal biopsy: a questionnaire-based survey Am J Kidney Dis. 2000; 35: 448-457.

ASSESSING THE ROLE OF HIGHRESOLUTION MICRO-ULTRASOUND AMONG NAÏVE PATIENTS WITH A NEGATIVE MULTIPARAMETRIC MRI AND PERSISTENT SUSPICION OF PROSTATE CANCER

Avolio PP1,2, Lughezzani G1,2, Fasulo V1,2, Sanchez-Salas R3, Maffei D1,2, Paciotti M1,2, Saitta C1,2, De Carne F1,2, Saita A2, Hurle R2, Lazzeri M2, Guazzoni G1,2, Buffi NM1,2, Casale P2.

1 Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20090 Pieve Emanuele, Milan, Italy;

2 Department of Urology, IRCCS Humanitas Research Hospital, via Manzoni 56, 20089 Rozzano, Milan, Italy;

3 Department of Surgery, Division of Urology. McGill University. Montréal, Canada.

Background. Multiparametric magnetic resonance imaging (mpMRI) is an invaluable diagnostic tool in prostate biopsies (PBx) decision making. However, a non-negligible proportion of patients with a negative MRI (nMRI) may still harbour prostate cancer (PCa).

Objective. To assess whether micro-UltraSound (microUS) can help in sub-stratifying the presence of PCa and clinically significant PCa (i.e., any Gleason score ≥7 PCa; csPCa) in those patients with a nMRI despite a persistent clinical suspicion of PCa.

Design, Setting, and Participants. A total of 125 biop-

sy-naïve patients who underwent microUS-guided prostate biopsy (PBx) with ExactVu system, for persistent suspicion of PCa despite nMRI were prospectively enrolled.

Intervention. The Prostate Risk Identification using microUS (PRI-MUS) protocol was used to identify suspicious areas; PBx included targeted sampling of PRI-MUS≥3 areas and systematic sampling.

Outcome Measurements and Statistical Analysis. The primary endpoint was the assessment of microUS diagnostic accuracy in detecting csPCa. Secondary endpoints included determining: the proportion of patients with nMRI who may avoid PBx after microUS TRUS; presence of cribriform pattern on biopsy core examination; predictors of csPCa in patients presenting with nMRI; and comparing microUS-targeted and systematic PBx in identifying csPCa.

Results and Limitations. Considering csPCa detection rate, microUS showed optimal sensitivity and negative predictive value (respectively 97.1% and 96.4%), while specificity and positive predictive value were 29.7 % and 34.0%, respectively. 28 (22.4%) patients with negative microUS examination could have avoided PBx with 1 (2.9%) missed csPCa. Cribriform pattern was found in 14 (41.2%) of csPCa patients.In multivariable logistic regression models (MLRMs), positive microUS, age, digital rectal examination, and PSA density ≥0.15 emerged as independent predictors of PCa. Targeted and systematic sampling identified 33 (97.1%) and 26 (76.5%) csPCa, respectively. The main limitation of the current study is represented by its retrospective single-center nature on an operatordependent technology.

Conclusions. MicroUS represent a valuable tool to rule out the presence of csPCa among subjects with persistent clinical suspicion despite a nMRI.

DIAGNOSTIC PERFORMANCE OF MICRO-ULTRASOUND AT MRIGUIDED RECLASSIFICATION

BIOPSY IN PATIENTS UNDER ACTIVE SURVEILLANCE FOR LOW-RISK PROSTATE CANCER

Maffei D1,2, Fasulo V1,2, Avolio PP1,2, Saitta C1,2, Paciotti M1,2, De Carne F1,2, Colombo P1,3, Pasini L2, De Zorzi SZ2, Saita A2, Hurle R2, Lazzeri M2, Guazzoni GF1,2, Casale P2, Buffi NM1,2, Lughezzani G1,2

1 Department of Biomedical Sciences, Humanitas University, Milan - Italy;

2 IRCCS Humanitas Research Hospital, Department of Urology, Rozzano (Mi) - Italy;

3 IRCCS Humanitas Research Hospital, Department of Pathology, Rozzano (Mi) – Italy.

Background. Active surveillance (AS) represents the standard of care of low-risk prostate cancer (PCa). However, identification and monitoring of AS candidates remains challenging.

Micro-ultrasound (microUS) is a novel high-resolution imaging modality for transrectal ultrasonography (TRUS). We explored the impact of microUS TRUS and targeted biopsies in mpMRI-guided reclassification biopsies. Methods. Between October 2017 and September 2021

XXIII

we prospectively enrolled 100 patients scheduled for MRIguided reclassification biopsy at 1 year from diagnosis of ISUP 1 PCa. TRUS was performed using the ExactVu microUS system; PRI-MUS protocol was applied to identify suspicious lesions (i.e. PRIMUS score ≥3). All patients received target biopsies of any identified microUS and mpMRI lesions and complementary systematic biopsies. The proportion of patients upgraded to clinically significant PCa (defined as ISUP≥2 cancer; csPCa) at reclassification biopsies was determined, and the diagnostic performance of microUS and mpMRI were compared.

Results. 92 patients had a suspicious MRI lesion classified PI-RADS 3, 4 and 5 in respectively 28, 16 and 18 patients.

MicroUS identified lesions classified PRI-MUS 3, 4 and 5 in respectively 20, 50 and 12 patients, while 18 individuals had no suspicious lesions. 34 patients were upgraded to ISUP≥2 cancer and excluded from AS.

MicroUS and mpMRI showed a sensitivity of 94.1% and 100% and a NPV of 88.9% and 100% respectively in detecting ISUP≥2 patients. A microUS-mandated protocol would have avoided reclassification biopsies in 18 patients with no PRI-MUS ≥3 lesions at the cost of missing 4 upgraded patients.

Conclusion. MicroUS and mpMRI represent valuable imaging modalities showing high sensitivity and NPV in detecting csPCa, thus allowing their use for event-triggered reclassification biopsies in AS patients. MicroUS offers an alternative imaging modality to mpMRI for the identification and real-time targeting of suspicious lesions in AS patients.

digital rectal examination underwent transperineal prostate biopsy for abnormal PSA values (median 7.5 ng/ml). Before prostate biopsy, all patients underwent mpMRI and 68Ga-PET/CT examinations and mpMRI (PIRADS version 2 ≥ 3) or 68Ga-PET/CT index lesions suspicious for cancer (SUVmax ≥ 5 g/ml) underwent cognitive targeted cores (mpMRI-TPBx and PSMA-TPBx: four cores) combined with extended systematic prostate biopsy (eSPBx: median 18 cores). The procedure was performed transperineally using a tru-cut 18-gauge needle under sedation and antibiotic prophylaxis.

Results. PCa was found in 58/100 (58.0%) men; in detail, 44/58 (75.9%) were csPCa; mpMRI and 68Ga-PSMA showed 66/100 (66%) and 62/100 (60%) lesions suspicious for PCa, respectively. 68Ga-PSMA-TPBx vs. mpMRITPBx vs. eSPBx diagnosed 42 (95.4%) vs. 36 (81.8%) vs. 30 (68.2%) csPCa, respectively; mpMRI-TPBx vs. 68Ga-PSMATPBx showed a diagnostic accuracy of 76.9% vs. 84.9% in diagnosing csPCa.

Conclusion. 68GaPSMA PET/CT TPBx demonstrated good accuracy in the diagnosis of csPCa, which was not inferior to mpMRI TPBx (84.9% vs. 76.9%) improving the detection rate for cancer of systematic biopsy.

DIAGNOSTIC DIFFICULTIES IN A RARE CASE OF RENAL CELL CARCINOMA WITH XP11 TRANSLOCATION

Cirfeda P, Giurioli A, Campagna M, Colamonico O, Simoncini G, Leone M, DI Pinto A, Peluso M, Palazzo S.

Department of Urology, A. Perrino Hospital , Brindisi, Italy.

TARGETED

BIOPSY: 68GA-PSMA PET/TC VS . MPMRI IN THE DIAGNOSIS OF CLINICALLY SIGNIFICANT PROSTATE CANCER (CSPCA)

Pepe P1, Tsirgiotis A1, Panella P1, Barbera M2, Cosentino S3, Pennisi M1, Fraggetta F4

1 Unità Operativa di Urologia/Prostate Cancer Unit - Azienda Ospedaliera Cannizzaro - Catania;

2 Unità Operativa di Anatomia Patologica - Azienda Ospedaliera Cannizzaro - Catania;

3 Servizio Medicina Nucleare - Azienda Ospedaliera CannizzaroCatania;

4 Unità Operativa di Urologia - Ospedale Giovanni Paolo II di Sciacca.

Introduction. To evaluate the diagnostic accuracy of 68Ga-prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) vs. multiparametric magnetic resonance imaging (mpMRI) targeted biopsy (TPBx) in the diagnosis of clinically significant prostate cancer (csCaP: Grade Group ≥ 2). Materials and Methods. From January 2021 to June 2022, 100 patients (median age: 66 years) with negative

Translocation-associated renal cell carcinoma (t-RCC) is a relatively uncommon subtype of renal cell carcinoma characterized by recurrent gene rearrangements involving the TFE3 or TFEB loci. TFE3 and TFEB are members of the microphthalmia transcription factor (MiT) family, which regulate differentiation in melanocytes and osteoclasts. Renal cell carcinomas (RCCs) associated with Xp11 translocations have gene fusions involving TFE3, which has multiple gene partners. These tumors are histologically diverse, often have papillary, alveolar, and nested growth pattern with clear and eosinophilic cells and psammoma bodies and are seen commonly in children and young adults especially in women. The outcome of Xp11 translocation renal cell carcinoma is highly variable, with some patients surviving decades with indolent disease and others dying rapidly of progressive disease. For the aggressive cases of MiT family translocation carcinoma, the optimal therapy remains to be determined; however, new target therapies seem to be promising. We report a clinical case of a 49-year-old woman with an atypical clinical presentation and a very aggressive clinical course that represented a challenge in defining the diagnostic-therapeutic path.

PROSTATE

Granulomatous prostatitis, a very critical diagnosis

Giovanni Maria Fusco, Luigi Cirillo, Ernesto Di Mauro, Roberto La Rocca, Luigi Napolitano.

Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico II, I-80138 Naples, Italy.

SUMMARY

Granulomatous prostatitis (GP) is a benign inflammatory condition of the prostate, which may mimic prostate cancer (PCa). We present a case of GP in a 68-year-old patient with prior abdominal-perineal resection (APR).

KEY WORDS: Prostate cancer; granulomatous prostatitis; abdominal-perneal resection; transperineal biopsy.

INTRODUCTION

Prostate cancer (PCa) represents the most diagnosed cancers in men with an incidence of 1.4 million new cases worldwide (1). According to European Guidelines, diagnosis is based on digital rectal examination (DRE) and/or elevated serum prostate specific antigen (PSA), multiparametric magnetic resonance imaging (mpMRI), and prostate biopsy for definitive diagnosis (2). In men without an anal canal screening and diagnosis of PCa are very difficult, since DRE and transrectal ultrasound (TRUS) cannot be performed. Trans perineal, trans gluteal or transabdominal ultrasound guided biopsies have been described. Granulomatous prostatitis (GP) is a benign and rare inflammatory condition of the prostate, which may mimic PCa from a clinical, biochemical, and radiological point of view (3). We present a case of granulomatous prostatitis (GP) in patient with prior abdominal-perineal resection (APR).

CASE REPORT

A 68-year-old man with a family history of prostate and breast cancer presented to our urology department with progressive PSA elevation (6.64 ng/ml reference range: 0–4 ng/ml).

The patient current medical history was relevant for benign prostatic hyperplasia treated with Alpha-blocker 5-

ARI, and hypertension treated with lisinopril. His past medical history was positive for negative prostate biopsy and a rectal cancer.

In 2017 he underwent to neoadjuvant chemo-radiotherapy and APR for rectal adenocarcinoma treated followed by adjuvant chemotherapy, which precluded DRE and TRUS. The patient underwent a 1,5-Tesla prostate multiparametric magnetic resonance imaging (MRI) which determinate the presence of 21 mm nodular lesion characterized by low signal intensity on T2-weighted sequences that involved both the peripheral right lobe and apex (Figure 1A and B).

Figure 1A. mpMRI of the patient.

The lesion was scored according to the Prostate ImagingReporting and Data System v2: PI-RADS 5 and due to high probability of malignancy prostate biopsy was necessary. The patient underwent trans perineal prostate biopsy, that showed aggregates of lymphocytes, plasma cells, histiocytes and epithelioid cells, together multinucleated giant cells. All these aspects were compatible with GP. The patient underwent observation.

DISCUSSION

Several prostate conditions are related to PSA elevation. Among these GP is an important issue, that should be considered. It is usually associated with increased PSA levels and suspicious area to digital rectal exploration and MRI. Histological evaluation is the gold standard to differentiate GP from PCa (3). In patients with APR, pre-biopsy mMRI is safety and subsequently a transperineal biopsy should be performed. Transperineal biopsy seems to be a feasible and important option to detect PCa in previous negative biopsy.

CONCLUSION

GP represents an urological entity that should be included in the differential diagnosis of PCa, and more studies are necessary to better improve prostate biopsy in patients underwent APR.

REFERENCES

1. Gandaglia G, Leni R, Bray F, et al. Epidemiology and Prevention of Prostate Cancer. Eur Urol Oncol. 2021; 4(6):877-892.

2. Mottet N, van den Bergh RCN, Briers E, et al. EAU-EANM-ESTROESUR-SIOG Guidelines on Prostate Cancer-2020 Update. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2021; 79(2):243-262.

3. Gillard R, Médart L, Parisel A. Granulomatous Prostatitis Mimicking Invasive Prostate Cancer. J Belg Soc Radiol. 2022; 106(1):64.

CORRESPONDENCE

Luigi Cirillo, MD

Department of Neurosciences, Reproductive Sciences and Odontostomatology, Urology Unit, University of Naples “Federico II”, Via Sergio Pansini, 5 - 80131 Naples (NA), Italy

E-mail: cirilloluigi22@gmail.com

Phone: +390817462611 - Fax: +390815452959

Figure 1B. mpRMN of the patient.

Prostate fusion biopsy: cost analysis in 2022 for transrectal and transperineal prostate biopsies under local anesthesia

Andrea Fandella, Stefano Guazzieri, Gaetano Loiero

SUMMARY

Introduction. Prostate cancer has an important incidence and mortality yet the best diagnostic procedure is to be defined. The latest scientific works aim at the use for diagnostic purposes of multiparametric magnetic resonance (mpMRI) according to the PiRads V.2 criteria. The aim of the work is to quantify the overall cost of the diagnosis obtained with the use of mpMRI before the transrectal or transperineal echo-guided prostate biopsy and to evaluate the economic impact of some current-use prostate biopsy strategies such as cognitive fusion biopsy, software fusion and with the Target or Target strategy with a systemic scheme. Material and methods. Both the procedures were undertaken on local anaesthesia. The total cost of mpMRI-guided transrectal biopsy was determined by referring to the experience of 239 procedures performed in 2022.The total cost of mpMRI-guided transperineal biopsy was determined by referring to the experience of 89 procedures performed in 2022. The following cost factors were assessed: personnel, materials, maintenanceequipment depreciation, energy consumption and common costs of structure. A review of the literature was also performed to verify the correspondence of the costs that we extrapolated with those of other international operating entities. The "cost of the mpMRI-guided biopsy" was analysed in the context

INTRODUCTION

The literature review points out transrectal ultrasound guided biopsy (TRUSB) as an invasive tool for diagnosing prostatic carcinoma clinically and economically controversial. Post mortem report the presence of cancer cells in the prostate of 50% of 70-year-old men, while extrapolations calculate a morbidity from prostatic carcinoma in 9.5% of 50-year-old men (1-2). It is therefore obvious that randomised prostatic biopsies, methods apart, have a good probability of being positive (1-2). This probability varies with the patient\quote and age, the level of prostate specific antigen (PSA), the density of PSA/cm3

of effectiveness of the strategies for the early diagnosis. Results. The overall cost of the transrectal cognitive fusion biopsy was € 570,80; data obtained by adding together the costs of: personnel (€ 253,00); materials (€ 188,00); maintenance - depreciation of equipment (€ 82,30); energy consumption (€ 0,20); general costs of hospital care (€ 47.500).

The overall cost of the transperineal cognitive fusion biopsy was € 630,80; data obtained by adding together the costs of: personnel (€ 273,00); materials (€ 188,00); maintenance - depreciation of equipment (€ 82,30); energy consumption (€ 0,20); general costs of hospital care (€ 87.500).

For both the procedure to be added the cost of amortization of hardware and software for computer-assisted fusion, this depends on the initial purchase cost and the number of annual biopsy procedures, if the ultrasound is not dedicated only to biopsies but is also used for other procedures the costs are spread over a greater number of procedures and so they go down. It can be assumed that for 250 procedures a year the impact of a fusion machine can add from € 50 to 140 to each procedure according to the initial cost of the machine, maintenance, any dedicated consumables, and operator time.

KEY WORDS: Prostate cancer –fusion biopsy - ultrasound - mpMRI.

of prostate volume (PSAD), detection by digital exploration and/or positive transrectal ultrasound (2)

Despite severe application of all these criteria and critical assessment of the patient\quotes general conditions, TRUSB was indicated for 16% of the male population over 50 years old, with obvious economic consequences (1-2). The introduction of multiparametric Magnetic Resonance Imaging of the prostate (mpMRI) is deeply changing the diagnostic path for prostate cancer (3-9).

A biopsy is the only way for a definitive diagnosis of prostate cancer (1). In Italy the cost of transrectal prostate biopsy was calculated in 1998 and based on the sextant

Divisione Urologica - Casa di Cura Rizzola San Donà di Piave, Venezia, Italy.

A. Fandella, S. Guazzieri, G. Loiero

scheme in use in those years and the Lire the old Italian currency. (10).

Then it was calculated the costs in Euro in 2011 (11). The purpose of this study was to assess how the introduction mpMRI , and the platform for fusion biopsy have affected the costs of the procedure.

The procedure need a mpMRI analyzed by an expert Radiologist , the biopsy device, with or without a fusion device a transrectal ultrasound probe, the needle and some disposable items (glove, plastic sheet, needle guidance, gel).

The full cost to perform the biopsy is the sum of the costs of all resources involved in performing this biopsy method. The cost of mpMRI is the real cost of the execution of the procedure, the costs of personnel and the amortization of the hardware used for other procedures (12-13). The costs of each factor participating in prostate fusion biopsy were separately analyzed and reported.

METHODS

The total cost of mpMRI -guided biopsy was determined by referring to the experience of 239 transrectal procedures and by referring to the experience of 89 transperineal procedures performed in 2022 with standard 12 samples plus 2-4 target biopsy. There were evaluated the following cost factors: personnel, materials (principals, drugs and films), maintenance and depreciation of equipment, energy consumption and cost of the property (imputed rent of the premises and participation in the overall costs of the hospital).

All resource costs involved in the process were calculated on a purchasing power of the Euro 2022. Indirect costs such as lost work time from the patient, the cost related to the loss of free time, the cost of transporting the patient, the time to reach the hospital and the costs related to complications were not calculated. This kind of costs are theoretical and go further the purpose of this analysis and dealing with uncertainty are very difficult to extract. So only direct costs are examined (12-13). As for the cost of personnel, are involved in the procedure as more professionals, it’s down in the detail of the implementing rules by identifying, for each individual operator, 3 phases of activity:

1) A preliminary examination, such as the acceptance (phase A);

2) Real execution (phase B),

3) After execution, such as reporting (phase C).

For each of these phases and for each professional has been computed the execution time, its cost and the cost arising from the sum of all these phases and operators: cost of direct labour (13).

The execution time of mpMRI ultrasound-guided biopsy was set at optimal operating conditions: cooperative patient, experienced operator, logistics and environmental well suited.

In addition to the cost of work done for the direct execution of the procedure (direct labor costs) were also counted

any additions or corrections due to operational difficulties for patients poorly collaborating to unpredictable environmental disruptions, weariness of the professionals operating (cost of average time burden).

Finally it was also considered the cost of time to activities not directly related to the execution of the procedure, but indispensable to the life and service management: inventory management, archive, scientific activities, updating, management (labor costs indirect) (12-13).

It was also carried out a review of the literature in order to verify the correspondence of our data compared with those of other international and operational realities that figure “cost fusion biopsy ultrasound-guided” in the context of the broader debate about the cost-effectiveness of strategies for early detection of prostate cancer (14-20).

In the case of supplementary biopsies, exceeding the maximum of 12 standardized methodology “to the sextant,” there was a relative increase in costs due to increased unloading time and reading time. In fact, this possibility of little impact on the average total duration of the sampling procedures and preparation of samples will be prepared if you sent in the box associated with the transport (up to 3 carrots for “cage”, so do not affect the average total consumption of materials and of medical devices, its cost has been calculated under “corrective” to direct work. It would be calculated in about € 20,00 more expense. The average cost for mpMRI was € 281,00 (staff cost Radiologist and radiologic technician € 163,00, equipment cost (€ 119,00).

RESULTS

The overall cost of the transrectal cognitive fusion biopsy was € 570,80; data obtained by adding together the costs of: personnel (€ 253,00); materials (€ 188,00); maintenance - depreciation of equipment (€ 82,30); energy consumption (€ 0,20); general costs of hospital care (€ 47.500).

The overall cost of the transperineal cognitive fusion biopsy was € 630,80; data obtained by adding together the costs of: personnel (€ 273,00); materials (€ 188,00); maintenance - depreciation of equipment (€ 82,30); energy consumption (€ 0,20); general costs of hospital care (€ 87.500).

To be added the cost of amortization of hardware and software for computer-assisted fusion, this depends on the initial purchase cost and the number of annual biopsy procedures, if the ultrasound is not dedicated only to biopsies but is also used for other procedures the costs are spread over a greater number of procedures and so they go down. It can be assumed that for 250 procedures a year the impact of a fusion platform can add from € 40,00 to 120,00 to each procedure according to the initial cost of the machine, maintenance, any dedicated consumables, and operator time that it is usually tripled in the fusion method (loading of the mpMRI exam, extrapolation of the images, choice of target, synchronization of the mpMRI and ultrasound images).

DISCUSSION

The total cost of mpMRI transrectal cognitive fusion biopsy (21, 23) is in our experience € 570,80 for transrectal, and € 630,80 for transperineal local anaesthesia procedures, substantially corresponding to data reported in the literature (24).

For comparison the total cost of ultrasound-guided prostate transrectal biopsy (12 sample) without mpMRI and fusion devices, is around € 289,20 - more than in 2011 where was € 250,00 (11).

These data were obtained by adding up the costs of:

a) Personnel (doctor sampler, pathologist, pathology technician,nurse and secretary) of € 180.000

b) Materials (cutting needle, syringe, gloves, prepared slides; and 8 tablets of cotrimoxazole) equal to € 69.000 (additional € 19.000 are added to € if the appeals echogenic needle Chiba is used

c) Maintenance and depreciation of equipment (ultrasound, optical microscope, computer, printer, furnishing of the premises, etc..) equal to € 12.300

d) Energy consumption at a flat rate of € 0,40

e) Overhead costs of the hospital (proportion of use of the ambulance service, anaesthesia and resuscitation service, salaries of health care and administrative leadership, etc..) equal to € 27.500.

In detail, personnel costs are € 118.400 for the results of direct business, which must be added € 34.800 for corrective (average cost of a burden) and more € 26.800 for the indirect business.

For simple transperineal office prostate biopsy the cost was calculated in € 349,00, it is a time consuming procedure so in the same time you performed less procedure but the personnel need more work time to look after patients before to dismiss them.

For diagnostic tests and staging methods, the variations in the resource costs between the United States and other countries were mixed. The pooled baseline resource costs were 2.3 times higher in the United States than in other countries (24).

The item that affects more (64%) between the cost factors is related to personnel; on this item will therefore focus attention on identifying and streamlining procedures to reduce spending, especially with regard to the corrective work is directed (14% of total) and indirect (10%).

Another possible area of spending restraint, certainly more effective, is the rational use for mpMRI: in this sense moves the search for guidelines in the diagnosis of prostate cancer (1).

The inclusion of fusion biopsy mpMRI-guided as a step in a protocol of early diagnosis of prostate cancer is controversial from economic points of view (5-7), because reported resource costs for performing biopsy and clinical staging represented combined resource costs from several procedures, they should be interpreted with caution. Furthermore, reported resource costs for performing mpMRI and / or biopsy did not include the cost of complications resulting from these procedures. It has been reported that complication costs are directly correlated to the biopsy rate.

Resource costs associated with complications arising from biopsy should be reported separately from those for diagnostic procedures because the cost of complications depends on the number of infections, which ranges from 5% to 6%, and their severity (25-26).

The only way to reduce costs is reducing the number of negative (useless biopsy), in this way mpMRI could give some help (8-9).

The actual costs for the average patient seeking a first-line biopsy would actually include:

• The costs for the initial MRI

• The costs for the evaluation of the results of that MRI (as evaluated by an experienced and skilled uroradiologist)

• The costs for the systematic, 12-core, TRUS-guided biopsy

• The costs for the MRI/TRUS fusion-guided biopsy

Despite the rigorous application of all these criteria and the critical evaluation of the general state of the patient, as many as 16% of the male population over 50 years old only with PSA and the rectal findings maintain the indication to the eco-guided transrectal agobiopsy prostate, which has a reasonable economic weight. Recently, the use of mpMRI as a strategy to reduce the use of agobiopsy and increase its diagnostic efficacy would appear to be of clinical utility. We have calculated the costs of this approach. It is more difficult to calculate the effects of this approach at a distance, to check whether reducing the number of samples obtained reduces complications. If you decide not to biopsy negative mpMRI patients (21% or more of the population examined) the savings would be € 250,00 per patient (calculated on all patients who would have been biopsy candidates). Reducing the number of samples obtained at each biopsy would halve the costs of pathological anatomy.

These phases are evaluated and an aggregate risk for a particular lesion being cancerous is given by the radiologist, commonly as a PI-RADs score (6). Using this score, MRI provides an accurate diagnostic tool in prostate cancer with high specificity for high grade disease (6). The negative predictive value of MRI also provides an opportunity to delay or avoid a biopsy in cases where no lesion is detected (8-9). This could reduce both the cost of the biopsy and the potential risk of serious complications, such as sepsis, whose incidence is rising due to increasing rates of quinolone resistance (25-26-). Post-biopsy sepsis, while rare, is serious for those patients affected and costly to the healthcare system (27). Many cost studies assume that MRI negative patients would not undergo biopsy, however omission of systematic ultrasound guided biopsies may miss relevant cancers and may not reflect real-world practice (15).

An earlier Dutch study examined the cost case of using MRI and in bore MRI-guided biopsy as the primary initial diagnostic modality in the management of prostate cancer and found the approach to be nearly cost-equivalent to current management with a significant improvement in QALYs. A number of assumptions in this study may limit its generalizability including the low costs associated with

A. Fandella, S. Guazzieri, G. Loiero

multiparametric MRI (€ 300,00) and MRI-guided prostate biopsy (€ 800,00) (4). Another concern with the current models is that they assume that no biopsy is performed on men with negative imaging.The impact of “missed cancer” will need to be assessed in prospective studies. External to the issue of cost is that of value derived by the patient, especially in the indication of initial biopsy; even if an MRI-based initial evaluation of prostate cancer is non-cost effective it may still be desirable as approximately one third of ultrasound biopsies are upgraded when subsequently evaluated with MRI guidance (7)

Studies of mpMRI guided biopsy in men with prior negative ultrasound biopsy have shown an increased rate of detection of high grade tumors, especially in the anterior prostate, a region often poorly sampled in ultrasound-guided biopsy (28). A study from 2015 showed both cost savings in using MRI to inform repeat biopsy and that a large portion of repeat biopsies could be avoided (16). In patients undergoing mpMRI-guided biopsy after negative prior biopsy the possibility of avoiding systematic (non-targeted) biopsies as a cost saving measure has been raised. This approach should be used with caution as it appears that systematic biopsies still add value and detect some clinically relevant cancers in this setting (15). As MRI techniques continue to refine and MRI use in prostate cancer management grows, MRI before repeat prostate biopsy is likely to become increasingly common. cost of MRI. Three different cost analyses of prostate MRI used different costs for MRI. A study from a Dutch group used a cost of MRI at € 345,00, an American study using medicare reimbursement rates of $ 524,00 and a Canadian study using hospital expense of $ 900,00 (16-17, 28). The determination of baseline costs can result in significantly different conclusions especially if one considers using MRI in every patient with an elevated PSA. Such factors may limit the ultimate conclusion of a cost analysis to its nation of origin. In many healthcare environments, the limiting factor for MRI use may not be cost but availability (29).

The purest form of utilizing MRI information in prostate biopsy is performing multiparametric MRI and subsequent in-bore MRI-guided biopsy of suspicious lesions. While this approach demonstrates high quality performance characteristics (30), resource availability will likely limit its widespread use. An intermediate option is the use of MRI-ultrasound fusion hardware and software packages that allow the MRI data to be superimposed over live ultrasound images, guiding the provider during the biopsy. The utility of MRI-fusion software and hardware is itself a point of controversy. In theory a provider could review relevant MRI images and target a region of interest using ultrasound guidance, a practice used elsewhere in the body for the biopsy of metastases. This practice of viewing the MRI and targeting with ultrasound is generally referred to as “cognitive fusion” (31). The fusion approach involves use of software that overlays an MRI image on a “real-time” ultrasound image allowing assessment of the accuracy of the biopsy in relation to the MRI. A 2015 study in an ex vivo model showed greatly improved detection of relevant lesions using MRI machine-based fusion versus cognitive fusion (22), however a prospective, blinded

in-human study failed to show a difference in cancer detection between the two modalities (21). Similar results were found in another in-human 2013 prospective study which found no difference in cancer detection between machine-based fusion and cognitive fusion (23). A limitation in this study was the impossibility for us to study in our patients the diagnostic accuracy of transperineal versus transrectal biopsies (32) and the incidence of iatrogenic infection and sepsis; consideration should be given to enriching the patient population with men with intermediate-risk disease. These data could be of overwhelming importance to guide the choice to one procedure or the other (33 - 36).

CONCLUSIONS

mpMRI fusion biopsy is becoming the accepted method for diagnosing prostate cancer that allows the most cost / effective beneficial when done with proper instructions. The costs of transrectal € 570,80 and transperineal € 630,80 (+ € 40,00 - 120,00 for fusion platform each patient) are a problem as the availability of mpMRI and of skilled uroradiologists. but the benefit of this approach regarding the percentage of diagnoses of significant prostate cancer is clearly demonstrated. It is up to us urologists to correctly indicate the prostate biopsy by limiting ourselves to investigating patients with unequivocal risk factors, in this way we will have savings in the use of public health resources.

REFERENCES

1. Fandella A, Scattoni V, Galosi A, et al. Italian Prostate Biopsies Group: 2016 Updated Guidelines Insights. Anticancer Res. 2017 Feb;37(2):413-424.

2. Cooner WH, Mosley BR, Rutherford CL Jr, et al. Prostate cancer detection in a clinical urological practice by ultrasonography, digital rectal examination and prostate specific antigen. J Urol 1990:143(6):1146-54.

3. Thompson JE, Moses D, Shnier R,et al. Multiparametric magnetic resonance imaging guided diagnostic biopsy detects significant prostate cancer and could reduce unnecessary biopsies and over detection: a prospective study.J Urol. 2014; 192: 67-74.

4. Fütterer JJ, Briganti A, De Visschere P, et al. Can clinically significant prostate cancer be detected with multiparametric magnetic resonance imaging? A systematic review of the literature.Eur Urol. 2015; 68: 1045-1053.

5. Weinreb JC, Barentsz JO, Choyke PL, et al. PI-RADS Prostate Imaging-Reporting and Data System:2015,Version 2. Eur Urol 2016;69:16-40.

6. De Rooij M, Hamoen EH, Fütterer JJ, et al. Accuracy of multiparametric MRI for prostate cancer detection: a meta-analysis. AJR Am J Roentgenol 2014;202:343-51.

7. Siddiqui MM, Rais-Bahrami S, Truong H, et al. Magnetic resonance imaging/ultrasound-fusion biopsy significantly upgrades prostate cancer versus systematic 12-core transrectal ultrasound biopsy. Eur Urol 2013;64:713-9.

8. Kasivisvanathan V, Rannikko AS, Borghi M, et al. For the PRECISION

Prostate fusion biopsy: cost analysis in 2022 for transrectal and transperineal prostate biopsies under local anesthesia

Study Group Collaborators MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis N Engl J Med 2018; 378:1767-1777.

9. U Ahmed H, El-Shater Bosaily A, Brown L, et al. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study Lancet. 2017 Feb 25;389(10071):815-822.

10. Bissoli E, Fandella A, La Torre E, et al. Cost analysis of ultrasound-guided transrectal needle biopsy in prostatic carcinoma. Radiol Med 1998: 95 (4): 353-6.

11. Fandella A. Analysis of costs of transrectal prostate biopsy. Urologia. 2011 Oct-Dec;78(4):288-92. doi: 10.5301/RU.2011.8875.

12. Gold MR, Siegel JE, Russell LB, et al. Cost-effectiveness in health and medicine. New York (NY): Oxford University Press; 1996.

13. Dalla Palma F, Peterlongo P, Moser E, et al. Il controllo di gestione nelle Unità Operative di Radiologia Diagnostica. Promosan, Trento, 1994.

14. De Rooij M, Crienen S, Witjes JA, et al. Cost-effectiveness of magnetic resonance (MR) imaging and MR-guided targeted biopsy versus systematic transrectal ultrasound-guided biopsy in diagnosing prostate cancer: a modelling study from a health care perspective. Eur Urol 2014;66:430-6.

15. Salami SS, Ben-Levi E, Yaskiv O, et al. In patients with a previous negative prostate biopsy and a suspicious lesion on magnetic resonance imaging, is a 12-core biopsy still necessary in addition to a targeted biopsy? BJU Int 2015;115:562-70.

16. Lotan Y, Haddad AQ, Costa DN, et al. Decision analysis model comparing cost of multiparametric magnetic resonance imaging vs. repeat biopsy for detection of prostate cancer in men with prior negative findings on biopsy. Urol Oncol 2015;33:266.e9-16.

17. Cerantola Y, Dragomir A, Tanguay S, et al. Cost-effectiveness of multiparametric magnetic resonance imaging and targeted biopsy in diagnosing prostate cancer. Urol Oncol 2016;34:119.e1-9.

18. Barnett CL1, Davenport MS2, Montgomery JS3, et al. Costeffectiveness of magnetic resonance imaging and targeted fusion biopsy for early detection of prostate cancer. BJU Int. 2018 Jul;122(1):50-58.

19. Venderink W, Govers TM, de Rooij M, et al. Cost-effectiveness comparison of imaging-guided prostate biopsy techniques: systematic transrectal ultrasound, direct in-bore MRI, and image fusion. AJR Am J Roentgenol. 2017;22:1–6.

20. Hutchinson R, Lotan Y. Cost consideration in utilization of multiparametric magnetic resonance imaging in prostate cancer. Transl Androl Urol 2017;6(3):345-354.

21. Wysock JS, Rosenkrantz AB, Huang WC, et al. A prospective, blinded comparison of magnetic resonance (MR) imaging-ultrasound fusion and visual estimation in the performance of MR-targeted prostate biopsy: the PROFUS trial. Eur Urol 2014;66:343-51.

22. Cool DW, Zhang X, Romagnoli C, et al. Evaluation of MRI-TRUS fusion versus cognitive registration accuracy for MRI-targeted, TRUSguided prostate biopsy. AJR Am J Roentgenol 2015;204:83-91.

23. Puech P, Rouvière O, Renard-Penna R, et al. Prostate cancer diagnosis: multiparametric MR-targeted biopsy with cognitive and transrectal US-MR fusion guidance versus systematic biopsyprospective multicenter study. Radiology 2013;268:461-9.

24. Haffner J, Lemaitre L, Puech P, et al. Role of magnetic resonance imaging before initial biopsy, comparison of magnetic resonance imaging-targeted and systematic biopsy for significant prostate cancer detection BJU int 2011; 108: 1-8.

25. Loeb S, Vellekoop A, Ahmed HU, et al. Systematic review of complications of prostate biopsy. Eur Urol 2013;64:876-92.

26. Roth H, Millar JL, Cheng AC, et al. The state of TRUS biopsy sepsis: readmissions to Victorian hospitals with TRUS biopsy-related infection over 5 years. BJU Int 2015;116 Suppl 3:49-53.

27. Adibi M, Hornberg B, Bhat D et al. Reduction in hospital admissionrates due to post-prostatte biopsy infections after augmenting standard antibiotic prophylaxis. JUrol 2013; 189: 35-40.

28. Radtke JP, Boxler S, Kuru TH, et al. Improved detection of anterior fibromuscular stroma and transition zone prostate cancer using biparametric and multiparametric MRI with MRI-targeted biopsy and MRI-US fusion guidance. Prostate Cancer Prostatic Dis 2015;18:288-96.

29. Emery DJ, Forster AJ, Shojania KG, et al. Management of MRI wait lists in Canada. Healthc Policy 2009;4:76-86.

30. Pokorny MR, de Rooij M, Duncan E, et al. Prospective study of diagnostic accuracy comparing prostate cancer detection by transrectal ultrasound-guided biopsy versus magnetic resonance (MR) imaging with subsequent MR-guided biopsy in men without previous prostate biopsies. Eur Urol 2014;66:22-9.

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CORRESPONDENCE

Andrea Fandella, MD

Urology Department - Casa di Cura Rizzola San Donà di Piave, Via Gorizia, 1 - 30050 San Donà di Piave, Venezia, Italy

E-mail: afandella@libero.it

Instructions to Authors

AIMS AND SCOPE

Advances in Urological Diagnosis and Imaging is a free open access journal. The Journal has the purpose of promote, spread and favorite the scientific knowledge and research in diagnosis and imaging in Urology, Andrology and Nephrology.

Advances in Urological Diagnosis and Imaging publishes every 4 months original articles, reviews, case reports, position papers, guidelines, editorials, abstracts and congress proceedings.

To publish in Advances in Urological Diagnosis and Imaging is free

The official language of the journal is English

For papers with national interest because of local contents, in the “Italian Corner” it’s accepted their publication in Italian. The abstract must be in English. The editing of these papers follows the instructions below described.

All accepted paper will be published after a peer reviewed process.

AUTHORS’ RESPONSIBILITIES

Manuscripts are accepted with the understanding that they have not been published or submitted for publication in any other journal.

Authors must submit the results of clinical and experimental studies conducted according to the Helsinki Declaration on clinical research and to the Ethical Code on animal research set forth by WHO (WHO Chronicle 1985; 39:51).

The Authors must obtain permission to reproduce figures, tables and text from previously published material. Written permission must be obtained from the original copyright holder (generally the Publisher).

Manuscripts must be written in English language in accordance with the “Uniform Requirements for Manuscripts submitted to biomedical journals” defined by The International Committee of Medical Journal Editors (http://www.ICMJE.org).

Manuscripts in Italian language can be published only after translation (expenses will be charged to the Authors). Manuscripts should be typed double spaced with wide margins.

They must be subdivided into the following sections:

Title page

It must contain:

a) title;

b) a short (no more than 40 characters) running head title;

c) first, middle and last name of each Author without abbreviations;

d) University or Hospital, and Department of each Author;

e) last name, address and e-mail of all the Authors;

f) corresponding Author;

g) phone and/or fax number to facilitate communication;

h) acknowledgement of financial support;

i) list of abbreviations.

SUMMARY

The Authors must submit a long English summary (300 words, 2000 characters). Subheadings are needed as follows: Objective(s), Material and method(s), Result(s), Conclusion(s). After the Summary, three to ten key words must appear, taken from the standard Index Medicus terminology.

TEXT

For original articles concerning experimental or clinical studies, the following standard scheme must be followed: Summary - Key Words - Introduction - Material and Methods - Results - Discussion - Conclusions - References

- Tables - Legends - Figures.

Case Report should be divided into: SummaryIntroduction (optional) - Case report(s) - ConclusionsReferences (Discussion and Supplementary Figures, Tables and References can be submitted for publication in Supplementary Materials).

SIZE OF MANUSCRIPTS

Literature reviews, Editorials and Original articles concerning experimental or clinical studies should not exceed 3500 words with 3-5 figures or tables, and no more than 30 references.

Case reports, Notes on surgical technique, and Letters to the Editors should not exceed 1000 words (Summary included) with only one table or figure, and no more than three references. No more than five Authors are permitted.

REFERENCES

References must be sorted in order of quotation and numbered with arabic digits between parentheses. Only the references quoted in the text can be listed. Journal titles must be abbreviated as in the Index Medicus. Only studies published on easily retrieved sources can be quoted. Unpublished studies cannot be quoted, however articles “in press” can be listed with the proper indication of the journal title, year and possibly volume. References must be listed as follows:

• Journal articles

All Authors if there are six or fewer, otherwise the first three, followed by “et al.”. Complete names for Work Groups or Committees. Complete title in the original language. Title of the journal following Index Medicus

rules. Year of publication; Volume number: First page.

Example: Starzl T, Iwatsuki S, Shaw BW, et al. Left hepatic trisegmentectomy. Surg Gynecol Obstet. 1982; 155:21.

• Books

Authors - Complete title in the original language. Edition number (if later than the first). City of publication: Publisher, Year of publication.

Example: Bergel DIA. Cardiovascular dynamics. 2nd ed. London: Academic Press Inc., 1974.

• Book chapters

Authors of the chapters - Complete chapter title. In: Book Editor, complete Book Title, Edition number. City of publication: Publisher, Publication year: first page of chapter in the book.

Example: Sagawa K. The use of central theory and system analysis. In: Bergel DH (Ed), Cardiovascular dynamics. 2nd ed. London: Academic Press Inc., 1964; 115.

TABLES

Tables must be aimed to make comprehension of the written text easier. They must be numbered in Arabic digits and referred to in the text by progressive numbers. Every table must be accompanied by a brief title. The meaning of any abbreviations must be explained at the bottom of the table itself.

FIGURES

Figures are also graphics, algorithms, photographs, drawings.

Figures must be numbered and quoted in the text by number.

The meaning of all symbols, abbreviations or letters must be indicated.

Histology photograph legends must include the enlargement ratio and the staining method. Legends must be collected in one or more separate pages. Please follow these instructions when preparing files:

• Do not include any illustrations as part of your text file.

• Do not prepare any figures in Word as they are not workable.

• Line illustrations must be submitted at 600 DPI.

• Halftones and color photos should be submitted at a minimum of 300 DPI.

MANUSCRIPT REVIEW

Only manuscript written according to the above mentioned rules will be considered.

All submitted manuscripts are evaluated by the Editorial Board and/or by two referees designated by the Editors. The Authors are informed in a time as short as possible on whether the paper has been accepted, rejected or if a revision is deemed necessary.

The Editors reserve the right to make editorial and liter-

ary corrections with the goal of making the article clearer or more concise, without altering its contents.

Submission of a manuscript implies acceptation of all above rules.

MANUSCRIPT PRESENTATION

Authors must submit their manuscripts (MAC and WINDOWS Microsoft Word are accepted) to the Assistant Editor (dellatti@hotmail.com).

PROOFS

Authors are responsible for ensuring that all manuscripts are accurately typed before final submission. Galley proofs will be sent to the Corresponding Author. Proofs should be returned within seven days from receipt.

IMPORTANT TO KNOW

PAPERS ON : MEDICAL AND SURGICAL DEVICES, DIAGNOSTIC INSTRUMENTS, REGISTERED DRUGS , DIET SUPPLEMENTS , NUTRACEUTICALS

S.I.E.U.N. guarantees the Authors the publication of the article for scientific purposes completely free of charge. Each of the Authors is required to declare at the bottom of their article if they have received funding or grants from Sponsors for publication / study.

Papers that contain references to devices (medical and surgical), diagnostic instruments, registered drugs, diet supplements, nutraceuticals must not be used for commercial purposes without the authorization of Edizioni Scripta Manent.

The Authors are required to declare in the Copyright Assignment Form which possible Sponsors could be interested in a commercial use of the reprints.

Sponsor are requested to buy a minimum amount of 100 reprints at a cost of € 1.500 (1 to 4 pages) or € 2.000 (5 to 8 pages).

Prices for the purchase of number of reprints greater than 100 can be negotiated with Edizioni Scripta Manent. Edizioni Scripta Manent retains copyright for republishing and the distribution rights for commercial purpose.

TRANSLATION

Translation of manuscripts in Italian language is offered on payment.

Translation and reprints can be requested to Edizioni Scripta Manent by e-mail to info@edizioniscriptamanent.eu

EDIZIONI SCRIPTA MANENT

È LIETA DI PRESENTARE “BRICIOLE DI VITA DENTRO E FUORI LA CAMERA OPERATORIA” DI PINO FUNDARÒ, CARDIOCHIRURGO DALLE BATTUTE ARGUTE.

GLI SCENARI SONO QUELLI DI UNA QUOTIDIANITÀ STRAORDINARIA, VISSUTA IN PRIMA PERSONA E RIEVOCATA SUL FILO DELLA NOSTALGIA. 7€

E-book disponibile al seguente link: https://amzn.eu/d/2EIgDPt