Publications by authors named "Giovanni Lughezzani"

147 Publications

Feasibility, safety, and efficacy of ultrasound-guided transperineal laser ablation for the treatment of benign prostatic hyperplasia: a single institutional experience.

World J Urol 2021 Apr 3. Epub 2021 Apr 3.

Department of Urology, Humanitas Clinical and Research Center-IRCCS, Rozzano, Italy.

Purpose: To evaluate the feasibility, safety, and efficacy of ultrasound-guided transperineal laser ablation (TPLA) as a new minimally invasive surgical therapy (MIST) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).

Materials And Methods: Under local anesthesia and conscious sedation up to two laser fibers for each prostatic lobe were inserted under US-guidance by a percutaneous approach. TPLA was performed using a continuous wave diode laser (SoracteLite-EchoLaserX4) able to generate a light-induced thermal heating and subsequent coagulative necrosis of the prostatic tissue. Patients were evaluated at 3, 6, and 12 months after TPLA.

Results: Twenty-two consecutive patients were prospectively enrolled (median age 61.9 years). All procedures were well tolerated and no procedural complications were recorded. Median catheterization time was 7 days, while the median hospitalization time was 1 day. Three out of twenty-two patients (13.6%) experienced acute urinary retention and two (9.1%) of them urinary tract infection requiring major antibiotic treatment. At 3, 6, and 12 months, median prostate volume significantly decreased by a - 21.3%, - 29%, and - 41%, respectively. At the same time point, median IPSS was 8 (- 63.6%), 5 (- 74%), and 6 (- 75%), while median QoL score was 1 in all the scheduled timepoints of follow-up. The median postoperative Qmax at 3, 6, and 12 months improved by + 57.8%, + 98%, and + 115.8%, respectively. Ejaculatory function was preserved in 21 out of 22 patients (95.5%).

Conclusions: TPLA of the prostate appears to be a promising MIST for BPH. Long-term results and comparative studies against standard treatments are warranted before implementations of this technique in the urologist's armamentarium.
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http://dx.doi.org/10.1007/s00345-021-03685-7DOI Listing
April 2021

Oncology and complications.

Arch Ital Urol Androl 2021 Mar 19;93(1):71-76. Epub 2021 Mar 19.

Urology Department, General Hospital of Athens "G. Gennimatas", Athens.

This collection of cases describes some unusual urological tumors and complications related to urological tumors and their treatment. Case 1: A case of uretero-arterial fistula in a patient with long-term ureteral stenting for ureteral oncological stricture and a second case associated to retroperitoneal fibrosis were described. Abdominal CT, pyelography, cystoscopy were useful to show the origin of the bleeding. Angiography is useful for confirming the diagnosis and for subsequent positioning of an endovascular prosthesis which represents a safe approach with reduced post-procedural complications. Case 2: A case of patient who suffered from interstitial pneumonitis during a cycle of intravesical BCG instillations for urothelial cancer. The patient was hospitalized for more than two weeks in a COVID ward for a suspected of COVID-19 pneumonia, but he did not show any evidence of SARS-CoV-2 infection during his hospital stay. Case 3: A case of a young man with a functional urinary bladder paraganglioma who was successfully managed with complete removal of the tumor, leaving the urinary bladder intact. Case 4: A case of a 61 year old male suffering from muscle invasive bladder cancer who was admitted for a radical cystectomy and on the eighth postoperative day developed microangiopathic hemolytic anemia and thrombocytopenia, which clinically defines thrombotic microangiopathy.
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http://dx.doi.org/10.4081/aiua.2021.1.71DOI Listing
March 2021

Impact of high-intensity local treatment on overall survival in stage IV upper tract urothelial carcinoma.

Urol Oncol 2021 Mar 15. Epub 2021 Mar 15.

Division of Urological Surgery and Center for Surgery and Public Health, Brigham and Women's Hospital, Harvard Medical School, Boston, MA. Electronic address:

Objectives: To investigate the impact of high-intensity local treatment (LT) on overall survival (OS) in patients with stage IV upper tract urothelial carcinoma (UTUC).

Patients And Methods: Within the National Cancer Database, we identified 7,357 patients diagnosed with stage IV UTUC from 2004 to 2015. Patients who underwent high-intensity LT, defined as radical surgery of the primary tumor, were compared with those who did not. Inverse probability of treatment weighting (IPTW) was used to balance baseline characteristics. Weighted survival analyses were used to test the association between high-intensity LT and OS. Multivariable Cox model was used to assess for independent predictors of OS. Sensitivity analysis was used to account for possible biases.

Results: Among stage IV patients, 10.6% (n = 779) had locally advanced disease (T4), 32.6% (n = 2,399) had node-positive disease (N+) and 56.8% (N = 4,179) had distant metastases (M+). Fewer than half of the patients underwent high-intensity LT (n = 2,908, 39.5%) while the remainder did not. On IPTW-adjusted survival analysis, high-intensity LT was associated with a prolonged OS (11.17 months [IQR, 5.19 to 24.28] months vs. 6.18 months [IQR, 2.27 to 14.49], P ≤ 0.001). A similar benefit was seen on adjusted survival analyses for each stage IV subgroup, defined according to TNM characteristics. The survival benefit was confirmed at sensitivity analysis.

Conclusion: High-intensity LT in balanced cohorts of patients with stage IV UTUC is associated with prolonged OS including those with locally advanced (T4), node-positive (N+) or distant metastases (M+).
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http://dx.doi.org/10.1016/j.urolonc.2021.01.031DOI Listing
March 2021

Delayed Diagnosis of a Testicular Mass During COVID-19 Pandemic in Lombardy: A Case Report.

Res Rep Urol 2021 25;13:41-44. Epub 2021 Jan 25.

Department of Pathology, Humanitas Clinical and Research Center - IRCCS, Milan, Italy.

Signs and symptoms associated with testicular and paratesticular structures should not be underestimated because they may hide diseases requiring immediate evaluation and treatment, such as germline tumors or sarcomas, with the latter histotypes being more common among elderly patients. Unfortunately, the COVID-19 pandemic in Italy has led to a diagnostic delay of several malignancies and the impact of this delay has likely been underestimated. Paratesticular leiomyosarcoma represents a very rare subtype of sarcoma. Here we describe a 57-year-old man who presented to the emergency department with dyspnea and a voluminous mass in the right paratesticular region. At the appearance of the scrotal mass 9 months prior, he had refused to undergo a urological evaluation due to fear of contracting COVID-19. We present this case for its histological rarity and to document a case of diagnostic and therapeutic delay during the pandemic in Lombardy.
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http://dx.doi.org/10.2147/RRU.S297880DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7847766PMC
January 2021

Impact of chronic exposure to 5-alpha reductase inhibitors on the risk of hospitalization for COVID-19: a case-control study in male population from two COVID-19 regional centers of Lombardy (Italy).

Minerva Urol Nefrol 2021 Jan 13. Epub 2021 Jan 13.

Humanitas Clinical and Research Center - IRCCS -, Rozzano, Milano, Italy.

Background: There are sex differences in vulnerability to Coronavirus disease 2019 (COVID-19). The coronavirus S protein mediates viral entry into target cells employing the host cellular serine protease TMPRSS2 for S-protein priming. The TMPRSS2 gene expression is responsive to androgen stimulation and it could partially explain sex differences. We hypothesized that men chronically exposed to 5-alpha reductase inhibitors (5ARIs) for benign prostate hyperplasia (BPH) have a lower risk of hospitalization for COVID-19.

Methods: This is a population-based case-control study on consecutive patients positive for SARS-CoV-2 virus who required hospitalization for COVID-19 (cases), age-matched to beneficiaries of the Lombardy Regional Health Service (controls). Data were collected by two high-volume COVID-19 regional centers of Lombardy (Italy). The primary outcome was to compare the prevalence of patients chronically exposed to 5ARIs, who required hospitalization for COVID-19, with the one of controls.

Results: Overall, 943 males were enrolled; 45 (4.77%) were exposed to 5ARI. COVID-19 patients aged >55 years under 5ARI treatment were significantly less than expected on the basis of the prevalence of 5ARI treatment among age-matched controls (5.57 vs. 8.14%; p=0.0083, 95%CI=0.75-3.97%). This disproportion was higher for men aged >65 (7.14 vs. 12.31%; p=0.0001, 95%CI=2.83-6.97%). Eighteen 5ARIs-patients died; the mean age of men who died was higher than those who did not: 75.98±9.29 vs. 64.78±13.57 (p<0.001). Cox-regression and multivariable models did not show correlation between 5ARIs exposure and protection against intensive care unit admission/death.

Conclusions: Men exposed to 5ARIs might be less vulnerable to severe COVID-19, supporting its use in disease prophylaxis.
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http://dx.doi.org/10.23736/S0393-2249.20.04081-3DOI Listing
January 2021

Multiparametric magnetic resonance imaging and clinical variables: Which is the best combination to predict reclassification in active surveillance patients?

Prostate Int 2020 Dec 28;8(4):167-172. Epub 2020 May 28.

Department of Urology, ASST Papa Giovanni XXIII, Bergamo, Italy.

Introduction & Objectives: We tested the role of multiparametric magnetic resonance imaging (mpMRI) in disease reclassification and whether the combination of mpMRI and clinicopathological variables could represent the most accurate approach to predict the risk of reclassification during active surveillance.

Materials & Methods: Three-hundred eighty-nine patients (pts) underwent mpMRI and subsequent confirmatory or follow-up biopsy according to the Prostate Cancer Research International Active Surveillance (PRIAS) protocol. Pts with negative (-) mpMRI underwent systematic random biopsy. Pts with positive (+) mpMRI [Prostate Imaging Reporting and Data System, version 2 (PI-RADS-V2) score ≥3] underwent targeted + systematic random biopsies. Multivariate analyses were used to create three models predicting the probability of reclassification [International Society of Urological Pathology ≥ Grade Group 2 (GG2)]: a basic model including only clinical variables (age, prostate-specific antigen density, and number of positive cores at baseline), an Magnetic resonance imaging (MRI) model including only the PI-RADS score, and a full model including both the previous ones. The predictive accuracy (PA) of each model was quantified using the area under the curve.

Results: mpMRI negative (-) was recorded in 127 (32.6%) pts; mpMRI positive (+) was recorded in 262 pts: 72 (18.5%) had PI-RADS 3, 150 (38.6%) PI-RADS 4, and 40 (10.3%) PI-RADS 5 lesions. At a median follow-up of 12 months, 125 pts (32%) were reclassified to GG2 prostate cancer. The rate of reclassification to GG2 prostate cancer was 17%, 35%, 38%, and 52% for mpMRI (-), PI-RADS 3, 4, and 5, respectively ( < 0.001). The PA was 69% and 64% in the basic and MRI models, respectively. The full model had the best PA of 74%: older age ( = 0.023; Odds ratio (OR) = 1.040), prostate-specific antigen density ( = 0.037; OR = 1.324), number of positive cores at baseline ( = 0.001; OR = 1.441), and PI-RADS 3, 4, and 5 (overall  = 0.001; OR = 2.458, 3.007, and 3.898, respectively) were independent predictors of reclassification.

Conclusions: Disease reclassification increased according to the PI-RADS score increase, at confirmatory or follow-up biopsy. However, a no-negligible rate of reclassification was found also in cases of mpMRI (-). The combination of mpMRI and clinicopathological variables still represents the most accurate approach to pts on active surveillance.
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http://dx.doi.org/10.1016/j.prnil.2020.05.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7767935PMC
December 2020

How Can the COVID-19 Pandemic Lead to Positive Changes in Urology Residency?

Front Surg 2020 24;7:563006. Epub 2020 Nov 24.

Department of Urology, IEO European Institute of Oncology IRCCS, Milan, Italy.

The COVID-19 outbreak, in a few weeks, overloaded Italian hospitals, and the majority of medical procedures were postponed. During the pandemic, with hospital reorganization, clinical and learning activities performed by residents suffered a forced remodulation. The objective of this study is to investigate how urology training in Italy has been affected during the COVID-19 era. In this multi-academic study, we compared residents' training during the highest outbreak level with their previous activity. Overall 387 (67.1%) of the 577 Italian Urology residents participated in a 72-h anonymous online survey with 36 items sent via email. The main outcomes were clinical/surgical activities, social distancing, distance learning, and telemedicine. Clinical and learning activity was significantly reduced for the overall group, and after categorizing residents as those working only in COVID hospitals, both "junior" and "senior" residents, and those working in any of three geographical areas created (Italian regions were clustered in three major zones according to the prevalence of COVID-19). A significant decrease in outpatient activity, invasive diagnostic procedures, and endoscopic and major surgeries was reported. Through multivariate analysis, the specific year of residency has been found to be an independent predictor for all response modification. Being in zone 3 and zone 2 and having "senior" resident status were independent predictors associated with a lower reduction of the clinical and learning activity. Working in a COVID hospital and having "senior" resident status were independent predictors associated with higher reduction of the outpatient activity. Working in zone 3 and having "senior" resident status were independent predictors of lower and higher outpatient surgical activity, respectively. Working in a COVID hospital was an independent predictor associated with robotic surgical activity. The majority of residents reported that distance teaching and multidisciplinary virtual meetings are still not used, and 44.8% reported that their relationships with colleagues decreased. The COVID-19 pandemic presents an unprecedented challenge, including changes in the training and education of urology residents. The COVID era can offer an opportunity to balance and implement innovative solutions that can bridge the educational gap and can be part of future urology training.
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http://dx.doi.org/10.3389/fsurg.2020.563006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7732553PMC
November 2020

Multi-institutional Retrospective Validation and Comparison of the Simplified PADUA REnal Nephrometry System for the Prediction of Surgical Success of Robot-assisted Partial Nephrectomy.

Eur Urol Focus 2020 Nov 30. Epub 2020 Nov 30.

Department of Urology, Humanitas Clinical and Research Institute IRCCS, Rozzano, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy.

Background: The use of a nephron-sparing surgery for the treatment of localized renal masses is being pushed to more challenging cases. However, this procedure is not devoid of risks, and the Radius, Exophytic/Endophytic, Nearness, Anterior/Posterior, Location (RENAL) and Preoperative Aspects and Dimensions Used for an Anatomical (PADUA) classifications are commonly employed in the prediction of complications. Recently, the Simplified PADUA REnal (SPARE) scoring system has been proposed with the aim to provide a more simple system, to improve its reproducibility to predict postoperative risks.

Objective: We aim to retrospectively validate and compare the proposed new SPARE system in a multi-institutional population.

Design, Setting, And Participants: The Transatlantic Robotic Nephron-sparing Surgery (TRoNeS) study group collected data from 737 patients subjected to robot-assisted partial nephrectomy (RAPN) between 2010 and 2016 at three tertiary care referral centers. Of these patients, 536 presented complete demographic and clinical data.

Outcome Measurements And Statistical Analysis: Renal masses were classified according to the SPARE, RENAL, and PADUA nephrometry scores, and surgical success was defined according to the margin, ischemia, and complication scores.

Results And Limitations: Of 536 patients, 340 were male; the median age was 61 (53-69) yr and preoperative tumor size was 30 (22-43) mm. The margin, ischemia, and complication score was achieved in 399 of cases (74.4%). All three nephrometry scores were significant predictors of surgical outcomes both in univariate and in adjusted multivariate logistic regression model analysis. In accuracy analysis, the area under the curve (AUC) of the SPARE scoring system (0.73) was significantly higher than those of the PADUA (0.65) and RENAL (0.68) nephrometry scores in predicting surgical success.

Conclusions: The SPARE score appears to be a promising and reliable score for the prediction of surgical outcomes of RAPN, showing a higher accuracy relative to the traditional PADUA and RENAL nephrometry scores. Further, prospective studies are warranted before its introduction in clinical practice.

Patient Summary: The Simplified PADUA REnal (SPARE) score is a reproducible and simple nephrometry score, offering better predictive capabilities of surgical success and complications.
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http://dx.doi.org/10.1016/j.euf.2020.11.003DOI Listing
November 2020

Midterm follow-up (3 years) confirms and extends short-term results of intravesical gemcitabine as bladder-preserving treatment for non-muscle-invasive bladder cancer after BCG failure.

Urol Oncol 2021 03 23;39(3):195.e7-195.e13. Epub 2020 Oct 23.

Department of Urology, Humanitas Clinical and Research Center - IRCCS, Milan, Italy. Electronic address:

Background: There is a high demand for bladder sparing therapies in patients who do not respond to bacillus Calmette-Guérin (BCG).

Objective: To report the mid-term results of intravesical gemcitabine in non-muscle-invasive bladder cancer (NMIBC) patients, who failed BCG and who were unwilling to undergo radical cystectomy (RC).

Material & Methods: This is an extended confirmatory open-label, single-arm study, which enrolled consecutive patients who failed BCG or were BCG intolerant and unwilling to undergo the RC (histologically confirmed Tis (CIS), T1 high grade or multifocal Ta high grade of the urinary bladder). Intravesical gemcitabine was administered once a week for 6 consecutive weeks and once a month for 12 months. The primary outcome was disease-free survival (DFS) defined as the lack of tumor on cystoscopy and negative urine cytology. The secondary endpoint was safety, defined according a grading of side effects. overall survival, progression-free survival and DFS were described with Kaplan-Meier method at 12, 24, and 36 months.

Results And Limitations: Overall 46 patients were enrolled. The mean follow-up was 40 months. The DFS was 69.05% at the end of induction phase and 32.69% at 36 months. The progression-free survival at 36 months was 65.38%. The overall survival and cancer specific survival were 66.97% (95% confidence interval 47.25%-80.70%) and 78.71% (95% confidence interval 59.16%-89.66%), respectively. There was no life-threatening event or treatment related death (grade 4 or 5). The most common mild and moderate adverse events reported were urinary symptoms (lower urinary tract symptoms) and fatigue (G1-G2).

Conclusion: Intravesical gemcitabine seemed to represent a valid and safe alternative at 3 years follow-up for patients who failed BCG and were unwilling to undergo RC.
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http://dx.doi.org/10.1016/j.urolonc.2020.09.017DOI Listing
March 2021

Editorial Commentary referring to: "Is robot-assisted partial nephrectomy safe for highly complexity tumors?"

Transl Androl Urol 2020 Oct;9(5):2323-2325

Department of Urology, Humanitas Clinical and Research Center, Rozzano, Italy.

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http://dx.doi.org/10.21037/tau-20-936DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7658147PMC
October 2020

Retrotrigonal muscular layer sling associated with total anatomical reconstruction in robot-assisted radical prostatectomy and early continence.

World J Urol 2020 Oct 28. Epub 2020 Oct 28.

Department of Urology, Humanitas Mater Domini, Via Gerenzano 2, 21053, Varese, Castellanza, Italy.

Background And Purpose: Urinary continence (UC) represents the main non-oncological goal in patients undergoing robotic-assisted radical prostatectomy (RARP). To evaluate the efficacy in early UC achievement, we described a new sling technique using the retrotrigonal muscular layer (TZ sling) combined with total anatomical reconstruction (TAR).

Patients And Methods: We prospectively enrolled 407 consecutive prostate cancer (PC) patients undergoing RARP between May 2017 and January 2020. The first 250 patients underwent only TAR, while the following 157 patients TAR + TZ sling, by isolating and anchoring the retrotrigonal muscular layer to the pubic bone with 2 bilateral sutures. We defined UC as ≤ 1 pad/die, which was assessed after catheter removal at 1, 4 and 12wk using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score. Sling-related operative time and post-operative complications were analyzed.

Results: In the TAR group, the UC rates at the 1, 4 and 12wk were 58%, 66% and 86%; in the TAR + TZ sling group 72%, 76% and 88%, respectively. A statistically significant difference was observed in the two groups at 1wk (p = 0.0049) and 4wk (p = 0.035) favoring the TZ sling surgical strategy. This difference in UC rates was lost at 12wk (p ≥ 0.05). No statistically significant differences in operative time, acute urinary retentions and other complication rates were observed between the two groups (p = NS).

Conclusions: We have described a new, safe, feasible modification of RARP using a sling with the retrotrigonal muscular layer associated with TAR. We have demonstrated a statistically significant improvement in early UC rate in patients who are undergoing TAR and TZ sling compared to undergoing only TAR.
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http://dx.doi.org/10.1007/s00345-020-03500-9DOI Listing
October 2020

Diagnostic Accuracy of Microultrasound in Patients with a Suspicion of Prostate Cancer at Magnetic Resonance Imaging: A Single-institutional Prospective Study.

Eur Urol Focus 2020 Oct 14. Epub 2020 Oct 14.

Department of Urology, Humanitas Clinical and Research Center, Rozzano, Italy.

Background: Multiparametric magnetic resonance imaging (MRI) represents the gold standard for the diagnosis of clinically significant prostate cancer (csPCa). The search for alternative diagnostic techniques is still ongoing.

Objective: To determine the accuracy of microultrasound (microUS) for the diagnosis of csPCa within prospectively collected cohort of patients with a suspicion of prostate cancer (PCa) according to MRI.

Design, Setting, And Participants: A total of 320 consecutive patients with at least one Prostate Imaging Reporting and Data System (PIRADS) ≥3 lesion according to MRI were prospectively enrolled.

Intervention: All patients received microUS before prostate biopsy using the ExactVu system; the Prostate Risk Identification using microUS (PRI-MUS) protocol was used to identify targets. The urologists were blinded to MRI results until after the microUS targeting was completed. All patients received both targeted (based on either microUS or MRI findings) and randomized biopsies.

Outcome Measurements And Statistical Analysis: The sensitivity and specificity of microUS to determine the presence of csPCa (defined as at least one core with a Gleason score ≥7 PCa) were determined. Multivariable logistic regression analysis was fitted to determine the predictors of csPCa.

Results And Limitations: Clinically significant PCa was diagnosed in 116 (36.3%) patients. The sensitivity and negative predictive value of microUS for csPCa diagnosis were 89.7% and 81.5%, while specificity and positive predictive value were 26.0% and 40.8%, respectively. A combination of microUS-targeted and randomized biopsies would allow diagnosing the same proportion of csPCa as that diagnosed by an approach combining MRI-targeted and randomized biopsies (n = 113; 97.4%), with only three (2.6%) csPCa cases diagnosed by a microUS-targeted and three (2.6%) by an MRI-targeted approach. In a logistic regression model, an increasing PRI-MUS score was an independent predictor of csPCa (p ≤ 0.005). The main limitation of the current study is represented by the fact that all patients had suspicious MRI.

Conclusions: Microultrasound is a promising imaging modality for targeted prostate biopsies. Our results suggest that a microUS-based biopsy strategy may be capable of diagnosing the great majority of cancers, while missing only few patients with csPCa.

Patient Summary: According to our results, microultrasound (microUS) may represent an effective diagnostic alternative to magnetic resonance imaging for the diagnosis of clinically significant prostate cancer, providing high sensitivity and a high negative predictive value. Further randomized studies are needed to confirm the potential role of microUS in the diagnostic pathway of patients with a suspicion of prostate cancer.
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http://dx.doi.org/10.1016/j.euf.2020.09.013DOI Listing
October 2020

In-vitro and in-vivo new evidence for Flexor® Vue™ deflecting endoscopic system use: optimization of the stone free rate (SFR) after flexible ureteroscopy and Ho:YAG laser lithotripsy.

Urolithiasis 2020 Oct 1. Epub 2020 Oct 1.

Department of Urology, Humanitas Clinical and Research Center - IRCCS, Rozzano, Milan, Italy.

To test in-vitro and in-vivo the Flexor® Vue™ deflecting endoscopic system (FVDES) as a new technology able to improve the removal of residual intrarenal fragments.This is an observational prospective "proof of concept" study performed in patients with renal calculi treated with flexible ureteroscopy and Ho:YAG laser lithotripsy (f-URS) in Humanitas Research Hospital (Rozzano, Italy). We assessed feasibility, efficacy and safety of FVDES as an in-vivo tool for removing residual fragments after f-URS. The stone-free rate (SFR) at 30 days post-operatively was evaluated using CT. An in-vitro model was developed to evaluate the FVDES when used for this purpose.Eleven patients (M/F ratio: 7/4, mean age 63.5 ± 8.3) were treated. The stones were located in the lower calyces and the renal pelvis in 3 and 8 patients, respectively. Mean stone size was 18 ± 3.2 mm. The procedure with FVDES was feasible and effective in all the patients. Mean operative time was 82 ± 13.7 min and median hospitalization was of 1.5 days. The SFR after 90 days was 81% (9/11). We reported no relevant complications (Clavien-Dindo > 2); one patient had fever and was treated with antibiotics. The experimental in-vitro model demonstrated the efficacy of FVDES, allowing the removal of about 90% of fragments.Our study showed that FVDES is effective when used as a tool for retrieval of residual fragments at the end of f-URS. This technology could ensure a complete cleaning of the intrarenal collecting system and represent a safe alternative to basketing.
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http://dx.doi.org/10.1007/s00240-020-01215-5DOI Listing
October 2020

The relationship between hospital volume and outcomes of radical prostatectomy: a new perspective on an old story.

Gland Surg 2020 Aug;9(4):1072-1075

Department of Urology, Humanitas Clinical and Research Center IRCCS, Humanitas University, Rozzano, Italy.

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http://dx.doi.org/10.21037/gs.2020.01.08DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7475357PMC
August 2020

Comparison of micro-ultrasound and multiparametric magnetic resonance imaging for prostate cancer: A multicenter, prospective analysis.

Can Urol Assoc J 2021 Jan;15(1):E11-E16

Glickman Urological Institute, Cleveland Clinic, Cleveland, OH, United States.

Introduction: High-resolution micro-ultrasound has the capability of imaging prostate cancer based on detecting alterations in ductal anatomy, analogous to multiparametric magnetic resonance imaging (mpMRI). This technology has the potential advantages of relatively low cost, simplicity, and accessibility compared to mpMRI. This multicenter, prospective registry aims to compare the sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) of mpMRI with high-resolution micro-ultrasound imaging for the detection of clinically significant prostate cancer.

Methods: We included 1040 subjects at 11 sites in seven countries who had prior mpMRI and underwent ExactVu micro-ultrasound-guided biopsy. Biopsies were taken from both mpMRI targets (Prostate Imaging-Reporting and Data System [PI-RADS] >3 and micro-ultrasound targets (Prostate Risk Identification using Micro-ultrasound [PRIMUS] >3). Systematic biopsies (up to 14 cores) were also performed. Various strategies were used for mpMRI target sampling, including cognitive fusion with micro-ultrasound, separate software-fusion systems, and software-fusion using the micro-ultrasound FusionVu system. Clinically significant cancer was those with Gleason grade group ≥2.

Results: Overall, 39.5% were positive for clinically significant prostate cancer. Micro-ultrasound and mpMRI sensitivity was 94% vs. 90%, respectively (p=0.03), and NPV was 85% vs. 77%, respectively. Specificities of micro-ultrasound and MRI were both 22%, with similar PPV (44% vs. 43%). This represents the initial experience with the technology at most of the participating sites and, therefore, incorporates a learning curve. Number of cores, diagnostic strategy, blinding to MRI results, and experience varied between sites.

Conclusions: In this initial multicenter registry, micro-ultrasound had comparable or higher sensitivity for clinically significant prostate cancer compared to mpMRI, with similar specificity. Micro-ultrasound is a low-cost, single-session option for prostate screening and targeted biopsy. Further larger-scale studies are required for validation of these findings.
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http://dx.doi.org/10.5489/cuaj.6712DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7769516PMC
January 2021

The Role of Intraoperative Indocyanine Green in Robot-assisted Partial Nephrectomy: Results from a Large, Multi-institutional Series.

Eur Urol 2020 11 15;78(5):743-749. Epub 2020 Jun 15.

ORSI, Academy, Melle, Belgium; Department of Urology, Onze Lieve Vrouw Hospital, Aalst, Belgium.

Background: In recent years, novel technologies have been implemented in order to improve the surgical outcomes of robot-assisted partial nephrectomy (RAPN). Intraoperative administration of indocyanine green (ICG) has been proposed to assess kidney perfusion intraoperatively.

Objective: To confirm, on a large scale, the effectiveness of near-infrared fluorescence ICG-guided RAPN in leading the surgeon strategy and to provide hints to the use of this tool.

Design, Setting, And Participants: The Transatlantic Robotic Nephron-sparing Surgery (TRoNeS) study group collected data from 737 patients subjected to RAPN between 2010 and 2016 at three tertiary care referral centers. Of them, 318 had complete demographic and clinical data, and underwent ICG-guided RAPN for clinically localized kidney cancer.

Surgical Procedure: Patients were subjected to RAPN with intraoperative intravenous ICG injection.

Measurements: Optimal surgical outcomes, defined according to both the margin, ischemia, and complication (MIC), and the trifecta score, were assessed.

Results And Limitations: A total of 194 (61%) patients were male and 124 (39%) were female. The median patient age was 61 yr and median preoperative tumor size was 30 mm. Median operative time, estimated blood loss, and warm ischemia time were, respectively, 162 min, 100 ml, and 17 min. In total, 228 (71.7%) and 254 (79.9%) individuals, respectively, were selected as optimal surgical patients defined according to MIC and trifecta. The univariate and multivariable logistic regression models showed that tumor complexity nephrometry scores were independent predictors of both trifecta and MIC. The main limitation of this study is the lack of a control group.

Conclusions: We report the largest population of patients who underwent ICG-guided RAPN. Intraprocedural ICG administration represents a useful tool where the vascular anatomy is challenging, and it could be implemented to maximize the adoption of RAPN.

Patient Summary: We demonstrated that indocyanine green (ICG) is a reliable tool for guiding the surgeon strategy during robot-assisted partial nephrectomy. ICG may help in procedure tailoring, especially in cases with challenging vascularization or impaired renal function.
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http://dx.doi.org/10.1016/j.eururo.2020.05.040DOI Listing
November 2020

The Use of Multiparametric Magnetic Resonance Imaging for Follow-up of Patients Included in Active Surveillance Protocol. Can PSA Density Discriminate Patients at Different Risk of Reclassification?

Clin Genitourin Cancer 2020 Dec 4;18(6):e698-e704. Epub 2020 May 4.

Department of Urology, ASST Papa Giovanni XXIII, Bergamo, Italy; University of Milano-Bicocca, School of Medicine and Surgery, Monza, Italy.

Introduction: The objective of this study was to test Prostate Imaging Reporting and Data System (PI-RADS) classification on multiparametric magnetic resonance imaging (mpMRI) and MRI-derived prostate-specific antigen density (PSAD) in predicting the risk of reclassification in men in active surveillance (AS), who underwent confirmatory or per-protocol follow-up biopsy.

Materials And Methods: Three hundred eighty-nine patients in AS underwent mpMRI before confirmatory or follow-up biopsy. Patients with negative (-) mpMRI underwent systematic random biopsy. Patients with positive (+) mpMRI underwent targeted fusion prostate biopsies + systematic random biopsies. Different PSAD cutoff values were tested (< 0.10, 0.10-0.20, ≥ 0.20). Multivariable analyses assessed the risk of reclassification, defined as clinically significant prostate cancer of grade group 2 or more, during follow-up according to PSAD, after adjusting for covariates.

Results: One hundred twenty-seven (32.6%) patients had mpMRI(-); 72 (18.5%) had PI-RADS 3, 150 (38.6%) PI-RADS 4, and 40 (10.3%) PI-RADS 5 lesions. The rate of reclassification to grade group 2 PCa was 16%, 22%, 31%, and 39% for mpMRI(-) and PI-RADS 3, 4, and 5, respectively, in case of PSAD < 0.10 ng/mL; 16%, 25%, 36%, and 44%, in case of PSAD 0.10 to 0.19 ng/mL; and 25%, 42%, 55%, and 67% in case of PSAD ≥ 0.20 ng/mL. PSAD ≥ 0.20 ng/mL (odds ratio [OR], 2.45; P = .007), PI-RADS 3 (OR, 2.47; P = .013), PI-RADS 4 (OR, 2.94; P < .001), and PI-RADS 5 (OR, 3.41; P = .004) were associated with a higher risk of reclassification.

Conclusion: PSAD ≥ 0.20 ng/mL may improve predictive accuracy of mpMRI results for reclassification of patients in AS, whereas PSAD < 0.10 ng/mL may help selection of patients at lower risk of harboring clinically significant prostate cancer. However, the risk of reclassification is not negligible at any PSAD cutoff value, also in the case of mpMRI(-).
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http://dx.doi.org/10.1016/j.clgc.2020.04.006DOI Listing
December 2020

Prospective Evaluation of Ga-labeled Prostate-specific Membrane Antigen Ligand Positron Emission Tomography/Computed Tomography in Primary Prostate Cancer Diagnosis.

Eur Urol Focus 2020 Apr 17. Epub 2020 Apr 17.

Urology Department, Humanitas Clinical and Research Hospital, Rozzano, Milan, Italy.

Background: Positron emission tomography (PET)/computed tomography (CT) with Ga-labeled prostate-specific membrane antigen ligand (Ga-PSMA) may represent the most promising alternative to multiparametric magnetic resonance imaging (mpMRI) for prostate cancer (PCa) diagnosis.

Objective: To test the diagnostic performance of Ga-PSMA PET/CT in this clinical context.

Design, Setting, And Participants: From January 2017 to December 2018 we prospectively enrolled 97 patients with persistently elevated prostate-specific antigen and/or Prostate Health Index score, negative digital rectal examination, and previous negative biopsy. We also included patients with either negative mpMRI or contraindications to or positive mpMRI but previous negative biopsy.

Intervention: Patients underwent 68Ga-PSMA PET/CT with additional pelvic reconstruction.

Outcome Measurements And Statistical Analysis: The primary endpoint of the study was the diagnostic performance of Ga-PSMA PET/CT in detecting malignant lesions and clinically significant PCa (Gleason score [GS] ≥7).

Results And Limitations: Ga-PSMA PET/transrectal ultrasound fusion biopsy was performed in 64 of 97 patients (66%) for 114 regions of interest (ROIs). Forty patients (41%) had already undergone mpMRI with either a negative result for PCa (n = 15; 22 ROIs) or a positive mpMRI result but a previous negative biopsy. According to pathology, 23 patients (36%) had evidence of PCa: eight (16 ROIs) with GS 6, 13 (21 ROIs) with GS 7 (3 + 4 or 4 + 3), one (2 ROIs) with GS 8, and one (2 ROIs) with GS 10. Clinically significant PCa was identified in four patients with previous negative mpMRI (25%). PET/CT demonstrated PCa in seven patients (14 ROIs) with previous positive mpMRI and negative biopsy. The median maximum standardized uptake value (SUVmax) and median SUV ratio were significantly higher for PCa lesions than for benign lesions (p <  0.001). Optimal cutoff points obtained for SUVmax (>5.4) and SUV ratio (>2.2) could identify clinically significant PCa with accuracy of 81% and 90%, respectively.

Conclusions: In our cohort of patients with high suspicion of cancer,Ga-PSMA PET/CT was capable of detecting malignancy and accurately identifying clinically relevant PCa.

Patient Summary: Positron emission tomography/computed tomography with a Ga-labeled ligand for prostate-specific membrane antigen is capable of detecting prostate cancer in patients with a high suspicion of cancer and a previous negative biopsy.
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http://dx.doi.org/10.1016/j.euf.2020.03.004DOI Listing
April 2020

Renal Function Loss After Cryoablation of Small Renal Masses in Solitary Kidneys: European Registry for Renal Cryoablation Multi-Institutional Study.

J Endourol 2020 02 10;34(2):233-239. Epub 2020 Jan 10.

Bristol Urological Institute, North Bristol NHS Trust, Bristol, United Kingdom.

To estimate and quantify the loss of kidney function in solitary kidneys with small renal masses (SRMs) after laparoscopy-assisted renal cryoablation (LARC), from the European Registry for Renal Cryoablation (EuRECA) database. Of the 808 patients from eight European centers in the database, 102 patients had SRMs in solitary kidneys. Patient demographics, body mass index (BMI), American Society of Anesthesiologists (ASA) grade, Charlson comorbidity index, and tumor characteristics including nephrometry (PADUA) score where available were collected. Renal function data in the form of estimated glomerular filtration rate (eGFR) and chronic kidney disease (CKD) stratification both preoperatively and at 3 months postoperatively were collected. The median (interquartile range [IQR]) age was 67 (59-81) years, the median (IQR) BMI was 26 (23.9-28.9) kg/m, and the median (IQR) ASA score was 2 (2-3). The median Charlson score was 4 (range: 0-10). The median (IQR) tumor size in cross-sectional imaging was 26 (19-38) mm. The follow-up data were available for 72 patients with a median follow-up for this group of 38 (range: 10-132) months. The mean preoperative eGFR was 55.0 mL/minute/1.73 m (standard deviation [SD] = 18.1), and the mean postoperative eGFR was 51.8 mL/minute/1.73 m (SD = 18.8). The change was -3.1 mL/minute/1.73 m (95% confidence interval -5.2 to -1.0) units, which was statistically significant ( = 0.004). The change in the CKD stages comparing before and after LARC was not significant (paired two-tailed -test,  = 0.06). Critically, the decrease in the eGFR did not translate to any significant adverse outcome and zero patients required dialysis. To the best of our knowledge, this is the largest study of renal function after LARC in SRMs in solitary kidneys. Cryotherapy in this imperative situation is safe, carries clinically insignificant reduction in renal function, therefore providing an option to minimize the risk of developing renal failure necessitating dialysis.
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http://dx.doi.org/10.1089/end.2019.0669DOI Listing
February 2020

Clinical performance of Xpert Bladder Cancer (BC) Monitor, a mRNA-based urine test, in active surveillance (AS) patients with recurrent non-muscle-invasive bladder cancer (NMIBC): results from the Bladder Cancer Italian Active Surveillance (BIAS) project.

World J Urol 2020 Sep 5;38(9):2215-2220. Epub 2019 Nov 5.

Department of Urology, Istituto Clinico Humanitas IRCCS-Clinical and Research Hospital, via Manzoni 56, 20089, Milan, Rozzano, Italy.

Purpose: To investigate the clinical performance of a new mRNA-based urine test, aiming to avoid unnecessary follow-up cystoscopy in patients under active surveillance (AS) for recurrent NMIBC.

Methods: This is a prospective cohort study enrolling patients with history of low-grade (LG) NMIBC, who developed a recurrence during the follow-up and underwent AS. Their urinary samples were analyzed by Xpert BC Monitor (Cepheid, Sunnyvale, CA, USA). The primary endpoint was to investigate if Xpert BC Monitor could avoid unnecessary cystoscopy during the follow-up period. Its sensitivity, specificity, PPVs and NPVs were calculated. A cutoff of 0.4 "linear discriminant analysis" (LDA) was optimized for the AS setting.

Results: The cohort consisted of 106 patients with a mean age of 72 ± 9.52 and a median follow-up from AS start of 8.8 (range 0-56.5) months. No statistically significant difference was found for the mean age, smoker status, lesion size, and number of lesions with a cutoff of 0.4. Of 106 patients, 22 (20.8%) were deemed to require treatment because of cystoscopic changes in size and/or number of lesions during the follow-up period. Using a cutoff value of < 0.4, 34 (33.7%) cystoscopies could be avoided due to low LDA value, missing 2/22 (9%) failures, none with high-grade (HG) NMIBC. Further research on larger population remains mandatory before its clinical use.

Conclusion: Xpert BC Monitor seems to be a reliable assay, which might avoid unnecessary cystoscopies without missing HG NMIBC when its cutoff is optimized for the AS setting.
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http://dx.doi.org/10.1007/s00345-019-03002-3DOI Listing
September 2020

Comparison of the Diagnostic Accuracy of Micro-ultrasound and Magnetic Resonance Imaging/Ultrasound Fusion Targeted Biopsies for the Diagnosis of Clinically Significant Prostate Cancer.

Eur Urol Oncol 2019 05 25;2(3):329-332. Epub 2018 Oct 25.

Department of Urology, Humanitas Clinical and Research Center IRCCS, Rozzano, Italy.

Multiparametric magnetic resonance imaging (mpMRI) and MRI/ultrasound (US) fusion targeted biopsies are an increasingly popular alternative to randomized biopsies, but adoption of this technique has been limited owing to its additional costs and complexity. High-resolution micro-ultrasound (micro-US) is a real-time US-based imaging modality that allows real-time targeted prostate biopsies using the Prostate Risk Identification Using Micro-Ultrasound risk identification protocol. We compared the diagnostic accuracy of micro-US targeted biopsies (index test) and MRI/US fusion targeted biopsies (reference standard test) in detecting clinically significant prostate cancer (csPC), defined as Gleason ≥7 disease, in a prospectively collected cohort of 104 patients with suspected PC defined according to prostate-specific antigen, digital rectal examination, and the presence of at least one Prostate Imaging-Reporting and Data System ≥3 lesion at mpMRI. PC was diagnosed in 56 patients (54%) and csPC in 35 (34%). Micro-US sensitivity for csPC detection was 94%, with 33/35 csPC cases correctly identified. The negative predictive value was 90%, while the positive predictive value was 40% and the specificity was 28%. Of the 61 targeted zones concordant between micro-US and mpMRI, 24 were csPC. Discordant targeted lesions led to csPC discovery by micro-US in three cases and mpMRI in four cases. Both techniques missed one case for which csPC was diagnosed by systematic biopsies only. PATIENT SUMMARY: According to the results of our preliminary trial, micro-ultrasound may provide additional information regarding the presence or absence of clinically significant prostate cancer (PC) in patients with suspected PC. Further studies are warranted to investigate how this new imaging modality can best be leveraged within the PC diagnostic pathway.
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http://dx.doi.org/10.1016/j.euo.2018.10.001DOI Listing
May 2019

Pathological Outcomes for Patients Who Failed To Remain Under Active Surveillance for Low-risk Non-muscle-invasive Bladder Cancer: Update and Results from the Bladder Cancer Italian Active Surveillance Project.

Eur Urol Oncol 2018 10 5;1(5):437-442. Epub 2018 Jun 5.

Department of Urology, Istituto Clinico Humanitas IRCCS, Clinical and Research Hospital, Rozzano, Italy.

Background: It has been shown that active surveillance (AS) is feasible and effective in a subset of patients with recurrent low-grade (LG) non-muscle-invasive bladder cancer (NMIBC).

Objective: To update a previous preliminary series and investigate pathological outcomes for patients who failed to remain on AS.

Design, Setting, And Participants: Prospective observational cohort study started in February 2008, and currently still active, at a tertiary university hospital, including patients with pathologically confirmed NMIBC who experienced recurrence during follow-up.

Intervention: AS monitoring consisted of cytology and in-office flexible cystoscopy every 3 mo for the first year, and every 6 mo thereafter.

Outcome Measurements And Statistical Analysis: The primary endpoint was pathological results for patients who failed to remain on AS. The secondary outcome was an update of clinical results from our previous series. Data were complemented by descriptive statistical analysis and univariable and multivariable proportional hazards Cox regression.

Results And Limitations: Overall, 167 patients were included. Of 181 AS events, 61 (33.7%) were deemed to require treatment because of positive cytology (n=10), gross haematuria (n=11), and increases in the tumour number (n=15), or size (n=17), or both (n=8). The median time on AS was 12 mo (interquartile range 4-26). Pathological specimens from AS failures did not show any malignancy in 20 cases. Histopathology identified urothelial hyperplasia and oedema, submucosal vascular ectasia, mucosal erosion, polypoid cystitis, von Brunn nest hyperplasia, and squamous metaplasia. The time from first transurethral resection to AS start was inversely associated with recurrence-free survival (hazard ratio 0.97, 95% confidence interval 0.96-1.00; p=0.024). The study lacks statistical subanalyses focusing on patients with failure and negative neoplastic pathological outcomes.

Conclusions: AS might be a reasonable strategy in patients presenting with small LG pTa/pT1a recurrent bladder tumours. Approximately 30% of patients deemed to have AS failure did not harbour any neoplastic lesion, strengthening the role of AS.

Patient Summary: Patients with small low-grade pTa/pT1a recurrent papillary bladder tumours could benefit from an active surveillance protocol with no significant risk of pathological progression to muscle-invasive cancer.
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http://dx.doi.org/10.1016/j.euo.2018.05.006DOI Listing
October 2018

Predictive factors for progression of patients with carcinoma in situ of the bladder at long-term follow-up: pure versus non-pure CIS.

Minerva Urol Nefrol 2019 Aug 28;71(4):406-412. Epub 2019 May 28.

Department of Urology, Humanitas Clinic IRCCS, Rozzano, Milan, Italy.

Background: The aim of this study was to identify the predictive factors for progression defined as any event that shifted the management of the disease from a bladder sparing approach, by comparing patients with pure versus non-pure carcinoma in situ (CIS) of the bladder.

Methods: A retrospective analysis was carried out in consecutive patients affected by newly-diagnosed pure CIS and non-pure CIS (excluding cases with concomitant muscle invasive cancer). All patients were enrolled a in our institution from 1998 to 2010. Data was prospectively collected. Main end point was progression-free survival.

Results: Overall, 149 patients with CIS were identified for the analysis. A total of 98 patients had pure CIS (66%). Median follow-up was 103 months (range: 40-206 months). Progression occurred in 29 patients (19%). A total of 30 patients died during the follow-up (20%). In 13 cases (9%), the death was cancer specific. Progression-free survival estimate was 181 months (95% CI: 169-193 months) and 154 months (95% CI: 133-176 months) respectively for pure and non-pure CIS population (P=0.03). Among examined variables (age, gender, symptoms, smoking habit, ASA score, number of bacillus Calmette-Guérin [BCG] instillations), multivariate analysis disclosed that only CIS type was an independent predictor of progression (P=0.03) with a relative risk of 0.37 in favor of pure CIS.

Conclusions: Pure and non-pure CIS are efficiently treated by BCG therapy combined with trans-urethral resection and/or radical cystectomy, with relatively low rate of progression. CIS type was the only significant predictor of progression.
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http://dx.doi.org/10.23736/S0393-2249.19.03254-5DOI Listing
August 2019

Assessing the Feasibility and Accuracy of High-resolution Microultrasound Imaging for Bladder Cancer Detection and Staging.

Eur Urol 2020 06 10;77(6):727-732. Epub 2019 Apr 10.

Department of Urology, Humanitas Clinical and Research Center, Rozzano, Milan, Italy.

Background: Magnetic resonance imaging (MRI) has been proposed as a staging tool for bladder cancer (BC), but its use has been limited by its high costs and limited availability. Microultrasound (mUS) is a novel technology capable of providing high-resolution images of the prostate.

Objective: To test the feasibility of high-resolution mUS in patients diagnosed with BC and its ability to differentiate between non-muscle-invasive BC (NMIBC) and muscle-invasive BC (MIBC).

Design, Setting, And Participants: This is an observational prospective study performed in 23 patients with a diagnosis of primary BC scheduled for an endoscopic treatment.

Surgical Procedure: Micro-US was performed before transurethral resection of bladder tumor using the ExactVu system with an EV29L 29-MHz side-fire transducer (Exact Imaging, Markham, Canada).

Measurements: The endpoints were to test the feasibility, describe the normal bladder wall anatomy, identify the lesions, and compare the mUS findings with the histopathological results.

Results And Limitations: Micro-US was accurate in differentiating the three layers of the bladder wall in all cases. Bladder cancers were clearly identified as heterogeneous structures protruding from the normal bladder wall. In 14 cases the lesions appeared confined to the lamina propria, and in all cases NMIBC was confirmed by the final pathological report. In the other patients, the lesions seemed to extend into the muscular layer, but MIBC was confirmed in five out of seven cases (71.4%) from the pathologist. The small sample size was the main limitation of the current study.

Conclusions: Our findings showed that mUS is able to differentiate the bladder wall layers and identify the bladder cancer stage. Further studies with a larger population and imaging correlation with MRI are warranted before its introduction in clinical practice.

Patient Summary: In this report, a new imaging technique was tested for the characterization of bladder cancer. Microultrasound appears to be feasible and capable of discriminating between superficial and invasive tumors.
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http://dx.doi.org/10.1016/j.eururo.2019.03.044DOI Listing
June 2020

Robot-assisted Partial Nephrectomy for Complex (PADUA Score ≥10) Tumors: Techniques and Results from a Multicenter Experience at Four High-volume Centers.

Eur Urol 2020 01 19;77(1):95-100. Epub 2019 Mar 19.

Onze-Lieve-Vrouw Hospital, Aalst, Belgium; OLV Robotic Surgery Institute Academy, Melle, Belgium.

Background: Robot-assisted partial nephrectomy (RAPN) represents a widely accepted minimally invasive alternative to open and laparoscopic surgery for the treatment of clinically localized renal tumors.

Objective: To assess the feasibility of RAPN in a contemporary series of patients with highly complex tumors (PADUA score ≥10) treated at four high-volume robotic surgery institutions.

Design, Setting, And Participants: Data from a prospectively maintained multi-institutional database on patients subjected to RAPN between 2010 and 2017 were reviewed. For the scope of this analysis, only patients with highly complex renal tumors, defined as a PADUA score between 10 and 14, were included.

Surgical Procedure: RAPN was performed with the da Vinci Si or Xi surgical system (Intuitive Surgical, Sunnyvale, CA, USA) using novel technologies such as TilePro and near-infrared fluorescence imaging.

Measurements: Intraoperative, postoperative, surgical, and oncological outcomes were collected. Predictors of optimal surgical outcomes defined according to the Margin Ischemia and Complications binary system (absence of Clavien-Dindo >2 complications, warm ischemia time [WIT] <20min, and absence of positive surgical margins) were determined using logistic regression models (LRMs).

Results And Limitations: Overall, 255 patients with complex renal tumors were included. The mean operative time was 165min and mean WIT was 18.6min. Overall, WIT was longer than 20min in 86 (33.7%) individuals, while a Clavien-Dindo >2 complication and positive surgical margins were observed in 13 (5.1%) and four (out of 211 patients with malignant histotypes; 1.9%) individuals, respectively. Optimal surgical outcomes were achieved in 158 (62.0%) patients. At a median follow-up of 28mo, one (0.4%) local and two (0.8%) distant recurrences of the disease were observed. In multivariable LRMs, extremely complex tumors (PADUA score 12-13) were associated with an increased likelihood of not achieving optimal outcomes (odds ratio: 2.31; p=0.024). Besides tumor complexity, male gender was also associated with a two-fold higher risk of not achieving optimal surgical outcomes (p=0.029).

Conclusions: In experienced hands, RAPN can be considered as an effective treatment option even in cases of complex renal lesions. However, increasing tumor complexity may affect the surgical outcomes in this highly selected patient population.

Patient Summary: We reported our multicentric experience with robot-assisted partial nephrectomy (RAPN) in patients with complex renal tumors. We demonstrated that, in experienced hands, RAPN is a feasible and safe treatment option even in such patients. Novel technologies applied to RAPN may further extend the indications without compromising the outcomes.
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http://dx.doi.org/10.1016/j.eururo.2019.03.006DOI Listing
January 2020

Gender-specific risk factors for renal cell carcinoma: a systematic review.

Curr Opin Urol 2019 05;29(3):272-278

Department of Urology, Humanitas Clinical and Research Center, Rozzano, Milan, Italy.

Purpose Of Review: The relationship between gender and kidney cancer incidence/outcomes has been largely evaluated and may significantly impact the management of patients diagnosed with these tumors. We reviewed and summarized the most relevant recent publications reporting about this clinically meaningful relationship.

Recent Findings: The incidence of kidney cancer is higher in men than in women. Male gender is clearly associated with more aggressive histological characteristics both in terms of tumor stage and grade. Similarly, male gender has been found to be associated with worse perioperative and oncological outcomes. Several genetic and molecular markers that may partly explain these observed differences have been evaluated. However, the impact of these markers on clinical practice has not been clearly demonstrated.

Summary: Gender is significantly associated with kidney cancer incidence, characteristics and outcomes. Future efforts are still needed to explore the biological and molecular basis underlying of this relationship.
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http://dx.doi.org/10.1097/MOU.0000000000000603DOI Listing
May 2019

p2PSA for predicting biochemical recurrence of prostate cancer earlier than total prostate-specific antigen after radical prostatectomy: an observational prospective cohort study.

Minerva Urol Nefrol 2019 Jun 28;71(3):273-279. Epub 2019 Jan 28.

Department of Urology, Humanitas Clinical Institute IRCCS, Clinical and Research Hospital, Rozzano, Milan, Italy.

Background: There is an unmet clinical need for more biochemical specific tests that may detect clinically significant recurrent PCa at an early stage after radical prostatectomy (RP). Our purpose is to test the hypothesis that p2PSA (Index test) detects prostate cancer relapse (BCR) earlier than the current Reference Standard Test (total prostate-specific antigen [tPSA]) in patients who underwent RP for localized PCa.

Methods: This is an observational, prospective, cohort, follow-up study in patients subjected to RALP (robotic assisted laparoscopic radical prostatectomy) for clinically localized PCa from January 2013 to July 2013 at a high-volume Institution (450 average RP/year). A blood sample, for tPSA and p2PSA, was prospectively drawn after 3, 6, and 12 months and then every 6 months during the following two years. The primary outcome is to determine whether or not kinetics in rising of p2PSA significantly anticipates the tPSA kinetics. Exploratory data analysis was used to identify relationship between different variables.

Results: Over 134 patients 20 BCRs were detected according to tPSA cut-off. Five patients showed a contemporary increase of tPSA and p2PSA, 11 presented a p2PSA increase earlier than tPSA increase (13.9 months ±9.7). In four patients, the increase of PSA was not associated with a p2PSA>0.8 pg/mL. The correlation between tPSA and p2PSA according to Sperman's rho coefficient was statistically significant at 3, 6, 18 and 30 months: 0.416 (P<0.01), 0.255 (P<0.01), 0.359 (P<0.01) and 0.413 (P<0.01) respectively. When subjects were stratified according to stage/grade and margins (positive vs. negative), patients with higher stage and positive surgical margins could be considered the target categories. The low rate of observed BCR and high rate of p2PSA false positive are the main limitations.

Conclusions: The current findings showed that p2PSA might be more sensitive than tPSA in detecting earlier BCR within 3-year follow-up. Further studies with a longer follow-up and larger population remain mandatory before considering p2PSA for clinical decision-making.
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http://dx.doi.org/10.23736/S0393-2249.19.03279-XDOI Listing
June 2019

Evolution of Robot-assisted Partial Nephrectomy: Techniques and Outcomes from the Transatlantic Robotic Nephron-sparing Surgery Study Group.

Eur Urol 2019 08 5;76(2):222-227. Epub 2018 Dec 5.

Department of Urology, Onze-Lieve-Vrouw Hospital, Aalst, Belgium; ORSI Academy, Melle, Belgium.

Background: Robot-assisted partial nephrectomy (RAPN) is considered a feasible minimally invasive alternative to open partial nephrectomy (OPN) for the surgical treatment of renal tumors.

Objective: To provide further evidence supporting the effectiveness of RAPN in a contemporary patient population treated at one of three tertiary care centers for robotic surgery and to describe the evolution of RAPN-based technical improvements.

Design, Setting, And Participants: The Transatlantic Robotic Nephron-sparing Surgery (TRoNeS) study group prospectively collected data from 635 patients subjected to RAPN for clinically localized kidney cancer between 2010 and 2016 at three high-volume tertiary care centers.

Surgical Procedure: RAPN was performed using methods outlined in the supplementary video using either the da Vinci Si or Xi surgical system (Intuitive Surgical, Sunnyvale, CA, USA).

Measurements: Clinical data were collected within a prospectively maintained multi-institutional database. Intra- and postoperative data as well as surgical outcomes were assessed. Descriptive statistical analysis was performed and multivariable logistic regression models were fitted to determine the predictors of surgical outcomes.

Results And Limitations: Mean patient age was 60.7yr and mean preoperative tumor size was 33mm. According to the PADUA score, 202 (31.8%) patients had a low-, 235 (37.0%) had an intermediate-, and 198 (31.2%) had a high-complexity tumor. In the majority of patients, a transperitoneal approach was used (n=447; 70.4%). Mean operative time was 156.3min and mean estimated blood loss was 171ml. Overall, 25 (3.9%) patients experienced a significant (Clavien-Dindo >2) complication after surgery. No statistically significant differences between pre- and postoperative creatinine values were observed (p≤0.823). Finally, optimal surgical outcomes defined according to the margin, ischemia, and complication score were achieved in 459 (72.3%) individuals. At a mean follow-up of 26mo, only two local and two distant recurrences of the disease were observed. Finally, in multivariable logistic regression models, tumor complexity was associated with the risk of not achieving optimal surgical outcomes.

Conclusions: RAPN represents an effective minimally invasive alternative to OPN in the treatment of clinically localized renal tumors.

Patient Summary: We reported contemporary experience with RAPN for the treatment of kidney cancer. RAPN appears to be a safe and effective procedure, resulting in optimal outcomes in the majority of individuals despite tumor complexity.
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http://dx.doi.org/10.1016/j.eururo.2018.11.038DOI Listing
August 2019

Early Catheter Removal After Robot-assisted Radical Prostatectomy: Results from a Prospective Single-institutional Randomized Trial (Ripreca Study).

Eur Urol Focus 2020 03 7;6(2):259-266. Epub 2018 Nov 7.

Urology, Humanitas Clinical and Research Hospital, Rozzano, Milan, Italy.

Background: The adoption of robotic technology in the treatment of prostate cancer (PCa) could lead to improvement in outcomes.

Objective: To evaluate feasibility, to compare functional outcomes, and to assess the economic benefits of removing catheter on the postoperative day (POD) 3 versus POD 5 after robot-assisted radical prostatectomy (RARP).

Design, Setting, And Participants: From September 2016 to May 2017, patients selected to undergo RARP for clinically localized PCa at a high-volume center were prospectively randomized into group 1 (POD 3; n=72) versus group 2 (POD 5, n=74).

Intervention: All patients underwent RARP with anatomical posterior and anterior reconstruction.

Outcome Measurements And Statistical Analysis: The primary endpoint was to compare acute urinary retention (AUR) and urinary leakage rate in the two groups. The secondary endpoints were early and mid-term postoperative functional outcomes assessed through questionnaires (ICIQ-MLUTS, IPSS), early continence rate, and postoperative pain/discomfort (visual analog scale score). The economic impact of early catheter removal was also assessed.

Results And Limitations: AUR was reported in two (1.4%) cases, one for each study group (p=0.9). One case of vesicourethral leakage was reported (0.7%) in group 1. Urethral discomfort and pain at discharge was significantly higher in group 2 (p=0.03). In our clinical practice, POD 3 catheter removal approach would determine a saving of approximately €80 000 and 405 d of hospitalization yearly. The main limitation is the small sample size.

Conclusions: Early catheter removal after RARP does not lead to an increase in perioperative complications. No negative effect on early and mid-term functional outcomes was observed. A significant impact on saving economic resources was reported.

Patient Summary: We demonstrated that early catheter removal has no negative effect on spontaneous voiding, complications, or urinary continence recovery after robot-assisted radical prostatectomy.
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http://dx.doi.org/10.1016/j.euf.2018.10.013DOI Listing
March 2020

Long-term outcomes of high-grade T1 bladder cancer treated with intravesical bacillus Calmette-Guérin: experience of a single center.

Minerva Urol Nefrol 2018 Oct 3;70(5):501-508. Epub 2018 Jul 3.

Department of Urology, Humanitas Clinical and Research Center, Rozzano, Milan, Italy -

Background: To assess the outcomes of patients with high-grade (HG) pT1 bladder cancer (BC) treated with intravesical BCG therapy.

Methods: The study population consisted of 185 patients with HG pT1 BC treated between 1998 and 2010. We aimed to determine recurrence-free (RFS) and progression-free survival (PFS), as well as the predictors of RFS and PFS.

Results: Overall, 143 (77.3%) patients were males. Median age was 72 years (IQR: 66-78). Tumor size was ≥3 cm in 100 (54.1%) individuals. Most patients had single tumors (125; 67.6%). Primary, progressive and recurrent patterns of presentation were observed in 146 (78.9%), 21 (11.4%), and 18 (9.7%) cases, respectively. After 2nd-look TURB, 127 (68.6%) patients had no residual disease, 44 (23.8%) had Ta/CIS, and 14 (7.6%) had T1 HG BC. Twenty-two (11.9%) patients experience early recurrence after BCG. Of these, 12 patients (54.5%) were diagnosed with Ta/CIS, while 10 (45.5%) were diagnosed with HG pT1 BC. The median follow-up was 93 months (IQR: 63-147). Ten-year RFS and PFS rates were 69.6 and 79.2%. In multivariable Cox regression models, female gender (HR=2.41; P=0.001), progressive (HR=2.03; P=0.030) and recurrent (HR=3.87; P<0.001) pattern of presentation emerged as independent predictors of RFS, while age ≥70 years (HR=2.13; P=0.027), presence of multiple tumors (HR=2.06; P=0.019), and early recurrence (HR=3.88; P<0.001) emerged as independent predictors of PFS.

Conclusions: Intravesical BCG appears to be an effective treatment for HG pT1 BC. Caution should be used in patients aged ≥70 years, with multiple tumors or experiencing early recurrence.
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http://dx.doi.org/10.23736/S0393-2249.18.03042-4DOI Listing
October 2018