International consensus panel for transurethral resection of bladder tumours metrics: assessment of face and content validity.

OBJECTIVE: To develop performance metrics that objectively define a reference approach to a transurethral resection of bladder tumours (TURBT) procedure, seek consensus on the performance metrics from a group of international experts. METHODS: The characterisation of a reference approach to a TURBT procedure was performed by identifying phases and explicitly defined procedure events (i.e., steps, errors, and critical errors). An international panel of experienced urologists (i.e., Delphi panel) was then assembled to scrutinise the metrics using a modified Delphi process. Based on the panel's feedback, the proposed metrics could be edited, supplemented, or deleted. A voting process was conducted to establish the consensus level on the metrics. Consensus was defined as the panel majority (i.e., >80%) agreeing that the metric definitions were accurate and acceptable. The number of metric units before and after the Delphi meeting were presented. RESULTS: A core metrics group (i.e., characterisation group) deconstructed the TURBT procedure. The reference case was identified as an elective TURBT on a male patient, diagnosed after full diagnostic evaluation with three or fewer bladder tumours of ≤3 cm. The characterisation group identified six procedure phases, 60 procedure steps, 43 errors, and 40 critical errors. The metrics were presented to the Delphi panel which included 15 experts from six countries. After the Delphi, six procedure phases, 63 procedure steps, 47 errors, and 41 critical errors were identified. The Delphi panel achieved a 100% consensus. CONCLUSION: Performance metrics to characterise a reference approach to TURBT were developed and an international panel of experts reached 100% consensus on them. This consensus supports their face and content validity. The metrics can now be used for a proficiency-based progression training curriculum for TURBT.

Open questions on lower urinary tract infections: Results of a Delphi consensus study.

BACKGROUND AND OBJECTIVE: This is a Delphi study that aims to explore expert consensus regarding open questions in current literature evidence on lower urinary tract infections (UTIs). This manuscript deals with adults and analyzed the most recent guidelines and meta-analysis on the topic. METHODS: A panel of leading urologists and urogynaecologists participated in a consensus-forming project using a Delphi method to reach consensus on gray zone issues on recurrent lower UTIns (rUTIs), asymptomatic bacteriuria (AB) in pregnant women, and catheter-associated UTIs (CAUTI) in adults. All the panelists were invited to participate the four phases consensus. Consensus was defined as ≥75% agreement. An ordinal scale (0-10) was used. A systematic literature review was analyzed for diagnostic workup and prevention of rUTIs, AB, and CAUTI. RESULTS: In total, 37 experts participated. All panelists participated in the four phases of the consensus process. Consensus was reached if ≥75% of the experts agreed on the proposed topic. Online meetings and a face-to-face consensus meeting was held in Milan in March 2023. Formal consensus was achieved for 12/13 items. CONCLUSIONS: This manuscript is a Delphi survey of experts that showed interest on some debated points on rUTIs, AB in pregnancy, and prevention of CAUTI. There is still little data on nonantibiotic prevention of UTIs and CAUTI; quite old studies have been reported on AB in pregnancy. The emerging problem of antibiotic resistance is relevant and nonantibiotic prophylaxis may play a role in its prevention.

Impacts on functional and oncological outcomes of Robotic-assisted Radical Prostatectomy 10 years after the US Preventive Service Taskforce recommendations against PSA screening.

OBJECTIVE: In the following years after the United States Preventive Service Task Force (USPSTF) recommendation against prostate cancer screening with PSA in 2012, several authors worldwide described an increase in higher grades and aggressive prostate tumors. In this scenario, we aim to evaluate the potential impacts of USPSTF recommendations on the functional and oncological outcomes in patients undergoing robotic-assisted radical prostatectomy (RARP) in a referral center. MATERIAL AND METHODS: We included 11396 patients who underwent RARP between 2008 and 2021. Each patient had at least a 12-month follow-up. The cohort was divided into two groups based on an inflection point in the outcomes at the end of 2012 and the beginning of 2013. The inflection point period was detected by Bayesian regression with multiple change points and regression with unknown breakpoints. We reported continuous variables as median and interquartile range (IQR) and categorical variables as absolute and relative percent frequencies. RESULTS: Group 1 had 4760 patients, and Group 2 had 6636 patients, with a median follow-up of 109 and 38 months, respectively. In the final pathology, Group 2 had 9.5% increase in tumor volume, 24% increase on Gleason ≥ 4+3 (ISUP 3) , and 18% increase on ≥ pT3. This translated to a 6% increase in positive surgical margins and 24% reduction in full nerve sparing in response to the worsening pathology. There was a significant decline in post-operative outcomes in Group 2, including a 12-month continence reduction of 9%, reduction in potency by 27%, and reduction of trifecta by 22%. CONCLUSIONS: The increasing number of high-risk patients has led to worse functional and oncologic outcomes. The initial rapid rise in PSM was leveled by the move towards more partial nerve sparing. Among some historical changes in prostate cancer diagnosis and management in the period of our study, the USPSTF recommendation coincided with worse outcomes of prostate cancer treatment in a population who could benefit from PSA screening at the appropriate time.

Diagnosis of prostate cancer with magnetic resonance imaging in men treated with 5-alpha-reductase inhibitors.

PURPOSE: The primary aim of this study was to evaluate if exposure to 5-alpha-reductase inhibitors (5-ARIs) modifies the effect of MRI for the diagnosis of clinically significant Prostate Cancer (csPCa) (ISUP Gleason grade ≥ 2). METHODS: This study is a multicenter cohort study including patients undergoing prostate biopsy and MRI at 24 institutions between 2013 and 2022. Multivariable analysis predicting csPCa with an interaction term between 5-ARIs and PIRADS score was performed. Sensitivity, specificity, and negative (NPV) and positive (PPV) predictive values of MRI were compared in treated and untreated patients. RESULTS: 705 patients (9%) were treated with 5-ARIs [median age 69 years, Interquartile range (IQR): 65, 73; median PSA 6.3 ng/ml, IQR 4.0, 9.0; median prostate volume 53 ml, IQR 40, 72] and 6913 were 5-ARIs naïve (age 66 years, IQR 60, 71; PSA 6.5 ng/ml, IQR 4.8, 9.0; prostate volume 50 ml, IQR 37, 65). MRI showed PIRADS 1-2, 3, 4, and 5 lesions in 141 (20%), 158 (22%), 258 (37%), and 148 (21%) patients treated with 5-ARIs, and 878 (13%), 1764 (25%), 2948 (43%), and 1323 (19%) of untreated patients (p < 0.0001). No difference was found in csPCa detection rates, but diagnosis of high-grade PCa (ISUP GG ≥ 3) was higher in treated patients (23% vs 19%, p = 0.013). We did not find any evidence of interaction between PIRADS score and 5-ARIs exposure in predicting csPCa. Sensitivity, specificity, PPV, and NPV of PIRADS ≥ 3 were 94%, 29%, 46%, and 88% in treated patients and 96%, 18%, 43%, and 88% in untreated patients, respectively. CONCLUSIONS: Exposure to 5-ARIs does not affect the association of PIRADS score with csPCa. Higher rates of high-grade PCa were detected in treated patients, but most were clearly visible on MRI as PIRADS 4 and 5 lesions. TRIAL REGISTRATION: The present study was registered at ClinicalTrials.gov number: NCT05078359.

Double-Layered Hand-Sewn versus Stapled Intestinal Anastomosis in Patients Who Underwent Ileal Urinary Diversion in Radical Cystectomy: A Comparative and Cost Effective Study.

INTRODUCTION: Intestinal anastomosis can be performed by hand suturing (single layer or double layer) or by a mechanical suturing machine. The aim of the study was to compare complications, operative time, and costs of the intestinal anastomosis techniques. METHODS: A retrospective comparative study was conducted including patients who underwent radical cystectomy and uretero-ileo-cutaneostomy or vescica ileale Padovana orthotopic neobladder. Double-layered hand-sewn intestinal anastomosis (HS-IA) were performed using Vicryl stitches. Mechanical-stapled intestinal anastomosis (MS-IA) were performed with a mechanical stapler. RESULTS: Data of 195 patients who underwent were collected. 100 (51.3%) patients underwent HS-IA and 95 (48.7%) patients underwent MS-IA. Considering the complications classified according to Clavien-Dindo, a statistical difference with higher incidence for grade one in the HS-IA both in the ileal conduit group and in the neobladder one than the MS-IA (15.8% and 8.7%, respectively, in HS-IA vs. 1.7% and none in MS-IA). There is not a significant difference in time to flatus and time to defecation. Difference is recorded in the ileal conduit groups for the length of stay (10 days, range 9-12 with HS-IA vs. 13 days range 12-16 days with MS-IA (p < 0.001). The cost of the suture thread used for a single operation was 0.40 euros, whereas the overall cost of a disposable mechanical stapler and one refill was 350.00 €. CONCLUSION: Both HS-IA and MS-IA are safe and effective for patients. The cost for the stapling device is 350 €, in contrast, the cost for Vicryl sutures is negligible.

Retrosigmoid ileal conduit without transposition of the left ureter after open radical cystectomy for bladder cancer.

OBJECTIVES: To assess perioperative outcomes, complications, and rate of uretero-ileal anastomotic stricture (UAS) in patients undergoing retrosigmoid ileal conduit after radical cystectomy (RC). PATIENTS AND METHODS: Clinical records of consecutive patients receiving retrosigmoid ileal conduit after open RC for bladder cancer between March 2016 and June 2020 at two academic centres were prospectively collected. Two expert surgeons performed all cases. Operating room (OR) time, estimated blood loss (EBL), transfusion rate, and 90-day postoperative complications classified according to the Clavien-Dindo system, were assessed. In particular, rate of UAS, defined as upper urinary tract dilatation requiring endourological or surgical management, was evaluated. RESULTS: A total of 97 patients were analysed. The median (interquartile range [IQR]) OR time was 245 (215-290) min, median (IQR) EBL was 350 (300-500) mL, and blood transfusions were given to 15 (15.5%) cases. There were no intraoperative complications. There were 90-day postoperative complications in 33 patients (34%), being major (Grade III-V) in 19 (19.6%). Two patients died from early postoperative complications. At a median (IQR) follow-up of 25 (14-40) months, there was only one case (1%) of UAS, involving the right ureter and requiring an open uretero-ileal re-implantation. CONCLUSION: The retrosigmoid ileal conduit is a safe and valid option for non-continent urinary diversion after RC, ensuring a very low risk of UAS at an intermediate-term follow-up.

Antibiotic prophylaxis in patients who had undergone to prostate biopsy in between the EMA warning era: effects of fluoroquinolones in diabetic and non-diabetic patients. Results of an observational cohort study.

PURPOSE: To investigate the effects of different antibiotic prophylaxis regimens in patients with diabetes mellitus (DM) candidates to trans-rectal ultrasound-guided prostate biopsy (TRUSPB). METHODS: 143 outpatients with DM who underwent TRUSPB during the period 2018-2020 were selected from a cohort of 1150 patients in 3 different institutions. Exclusion criteria were allergies, concomitant anti-platelet therapies and uncontrolled DM. Different antibiotic prophylaxis regimens were adopted. Bacterial resistance levels to fluoroquinolones into the different communities were also collected. Univariable and multivariable binomial logistic regression analyses were used to assess the odds ratio (OR) with 95% confidence intervals (CIs) testing the risk of infective complications' occurrence after adjusting for clinical covariates. RESULTS: Overall, DM patients were significantly associated with infective complications' occurrence (p < 0.001). No differences on the event of sepsis were found between diabetic and non-diabetic patients. Clinically relevant infections with fever > 37 °C were found in 9.1% and 1.5% (p < 0.001) in diabetic and non-diabetic patients, respectively. Trimethoprim-sulphametoxazole and fluoroquinolones were six times more efficient than Cefixime in non-diabetic patients. Fluoroquinolones confirmed the same effect in diabetic patients although the level of resistance in the period of study decreased only from 56 to 46%. CONCLUSION: Fluoroquinolones were active in antibiotic prophylaxis of diabetic patients who had undergone to TRUSPB independently from the level of bacterial resistance found in the community. These results conflict with the recent European warning and support the Japanese and American guidelines on the topic.

Prediction of significant renal function decline after open, laparoscopic, and robotic partial nephrectomy: External validation of the Martini's nomogram on the RECORD2 project cohort.

OBJECTIVES: Martini et al. developed a nomogram to predict significant (>25%) renal function loss after robot-assisted partial nephrectomy and identified four risk categories. We aimed to externally validate Martini's nomogram on a large, national, multi-institutional data set including open, laparoscopic, and robot-assisted partial nephrectomy. METHODS: Data of 2584 patients treated with partial nephrectomy for renal masses at 26 urological Italian centers (RECORD2 project) were collected. Renal function was assessed at baseline, on third postoperative day, and then at 6, 12, 24, and 48 months postoperatively. Multivariable models accounting for variables included in the Martini's nomogram were applied to each approach predicting renal function loss at all the specific timeframes. RESULTS: Multivariable models showed high area under the curve for robot-assisted partial nephrectomy at 6- and 12-month (87.3% and 83.6%) and for laparoscopic partial nephrectomy (83.2% and 75.4%), whereas area under the curves were lower in open partial nephrectomy (78.4% and 75.2%). The predictive ability of the model decreased in all the surgical approaches at 48 months from surgery. Each Martini risk group showed an increasing percentage of patients developing a significant renal function reduction in the open, laparoscopic and robot-assisted partial nephrectomy group, as well as an increased probability to develop a significant estimated glomerular filtration rate reduction in the considered time cutoffs, although the predictive ability of the classes was <70% at 48 months of follow-up. CONCLUSIONS: Martini's nomogram is a valid tool for predicting the decline in renal function at 6 and 12 months after robot-assisted partial nephrectomy and laparoscopic partial nephrectomy, whereas it showed a lower performance at longer follow-up and in patients treated with open approach at all these time cutoffs.

Preliminary Results of ERAS Protocol in a Single Surgeon Prospective Case Series.

Background and Objectives: The aim was to compare the intra and postoperative outcomes between the Enhanced Recovery After Surgery (ERAS) protocol versus the standard of care protocol (SCP) in patients who underwent radical cystectomy performed by a single surgeon. Materials and Methods: A retrospective comparative study was conducted including patients who underwent radical cystectomy from 2017 to 2020. Length of stay (LOS), incidence of ileus, early postoperative complications, and number of re-hospitalizations within 30 days were considered as primary comparative outcomes of the study. Results: Data were collected for 91 patients who underwent cystectomy, and 70 and 21 patients followed the SCP and ERAS protocol, respectively. The mean age of the patients was 70.6 (SD 9.5) years. Although there was a statistically significant difference in time to flatus (TTF) [3 (2.7−3) vs. 1 (1−2 IQR) days, p < 0.001, in the SC hospital and in the ERAS center respectively], no difference was reported in time to first defecation (TTD) [5 (4−6) vs. 4 (3−5.8), p = 0.086 respectively]. The median LOS in the SCP group was 12 (IQR 11−13) days vs. 9 (IQR 8−13 p = 0.024). In the postoperative period, patients reported 22 complications (37% in SCP and 42.8% in ERAS group, p = 0.48). Conclusions: The study reveals how even partial adherence to the ERAS protocols leads to similar outcomes when compared to SCP. As a single surgeon series, our study confirmed the role of surgeons in reducing complications and improving surgical outcomes.

Delayed surgery for localised and metastatic renal cell carcinoma: a systematic review and meta-analysis for the COVID-19 pandemic.

PURPOSE: The COVID-19 pandemic has led to the cancellation or deferment of many elective cancer surgeries. We performed a systematic review on the oncological effects of delayed surgery for patients with localised or metastatic renal cell carcinoma (RCC) in the targeted therapy (TT) era. METHOD: The protocol of this review is registered on PROSPERO(CRD42020190882). A comprehensive literature search was performed on Medline, Embase and Cochrane CENTRAL using MeSH terms and keywords for randomised controlled trials and observational studies on the topic. Risks of biases were assessed using the Cochrane RoB tool and the Newcastle-Ottawa Scale. For localised RCC, immediate surgery [including partial nephrectomy (PN) and radical nephrectomy (RN)] and delayed surgery [including active surveillance (AS) and delayed intervention (DI)] were compared. For metastatic RCC, upfront versus deferred cytoreductive nephrectomy (CN) were compared. RESULTS: Eleven studies were included for quantitative analysis. Delayed surgery was significantly associated with worse cancer-specific survival (HR 1.67, 95% CI 1.23-2.27, p < 0.01) in T1a RCC, but no significant difference was noted for overall survival. For localised ≥ T1b RCC, there were insufficient data for meta-analysis and the results from the individual reports were contradictory. For metastatic RCC, upfront TT followed by deferred CN was associated with better overall survival when compared to upfront CN followed by deferred TT (HR 0.61, 95% CI 0.43-0.86, p < 0.001). CONCLUSION: Noting potential selection bias, there is insufficient evidence to support the notion that delayed surgery is safe in localised RCC. For metastatic RCC, upfront TT followed by deferred CN should be considered.

Transperitoneal vs retroperitoneal minimally invasive partial nephrectomy: comparison of perioperative outcomes and functional follow-up in a large multi-institutional cohort (The RECORD 2 Project).

BACKGROUND: Aim of this study was to evaluate and compare perioperative outcomes of transperitoneal (TP) and retroperitoneal (TR) approaches in a multi-institutional cohort of minimally invasive partial nephrectomy (MI-PN). MATERIAL AND METHODS: All consecutive patients undergone MI-PN for clinical T1 renal tumors at 26 Italian centers (RECORd2 project) between 01/2013 and 12/2016 were evaluated, collecting the pre-, intra-, and postoperative data. The patients were then stratified according to the surgical approach, TP or RP. A 1:1 propensity score (PS) matching was performed to obtain homogeneous cohorts, considering the age, gender, baseline eGFR, surgical indication, clinical diameter, and PADUA score. RESULTS: 1669 patients treated with MI-PN were included in the study, 1256 and 413 undergoing TP and RP, respectively. After 1:1 PS matching according to the surgical access, 413 patients were selected from TP group to be compared with the 413 RP patients. Concerning intraoperative variables, no differences were found between the two groups in terms of surgical approach (lap/robot), extirpative technique (enucleation vs standard PN), hilar clamping, and ischemia time. Conversely, the TP group recorded a shorter median operative time in comparison with the RP group (115 vs 150 min), with a higher occurrence of intraoperative overall, 21 (5.0%) vs 9 (2.1%); p = 0.03, and surgical complications, 18 (4.3%) vs 7 (1.7%); p = 0.04. Concerning postoperative variables, the two groups resulted comparable in terms of complications, positive surgical margins and renal function, even if the RP group recorded a shorter median drainage duration and hospital length of stay (3 vs 2 for both variables), p < 0.0001. CONCLUSIONS: The results of this study suggest that both TP and RP are feasible approaches when performing MI-PN, irrespectively from tumor location or surgical complexity. Notwithstanding longer operative times, RP seems to have a slighter intraoperative complication rate with earlier postoperative recovery when compared with TP.

Accuracy of abbreviated multiparametric MRI-derived protocols in predicting local staging of prostate cancer in men undergoing radical prostatectomy.

BACKGROUND: Abbreviated magnetic resonance imaging (aMRI) protocols have emerged as an alternative to multiparametric MRI (mpMRI) to reduce examination time and costs. PURPOSE: To compare multiple aMRI protocols for predicting pathological stage ≥T3 (≥pT3) prostate cancer (PCa). MATERIAL AND METHODS: One hundred and eight men undergoing staging mpMRI before radical prostatectomy (RP) were retrospectively evaluated. 3.0-T imaging was performed with a 32-channel surface coil and a protocol including diffusion-weighted imaging (DWI), transverse T2-weighted (tT2W) imaging, coronal T2W (cT2W) imaging, sagittal T2W (sT2) imaging, and dynamic contrast-enhanced (DCE) imaging. Two readers independently assessed whether any MRI observation showed stage ≥T3 on each sequence (reading order: DWI, cT2W, tT2W, sT2W, DCE). Final stage was assessed by matching readers' assignments to pathology, and combining them into eight protocols: DWI + tT2W, DWI + cT2W + tT2W, DWI + tT2W + sT2W, DWI + cT2W + tT2W + sT2W, DWI + tT2W + DCE, DWI + cT2W + tT2W + DCE, DWI + tT2W + sT2W + DCE, and mpMRI. Diagnostic accuracy and inter-reader agreement for aMRI protocols were calculated. RESULTS: Prevalence of ≥pT3 PCa was 31.5%. Sensitivity, specificity, positive (PPV) and negative predictive value (NPV) of aMRI protocols were comparable to mpMRI for R1. Sensitivity was 74.3% (95% confidence interval [CI] 64.8-72.0) to 77.1% (95% CI 67.9-84.4), and NPV 86.8% (95% CI 78.6-92.3) to 88.1% (95% CI 80.1-93.3). All accuracy measures of the various aMRI protocols were similar to mpMRI also for R2, albeit all slightly lower compared to R1. On a per-protocol basis, there was substantial inter-reader agreement in predicting stage ≥pT3 (k 0.63-0.67). CONCLUSION: When comparing the diagnostic accuracy of multiple aMRI protocols against mpMRI for predicting stage ≥pT3 PCa, the protocol with the fewest sequences (DWI + tT2W) is apparently equivalent to standard mpMRI.

Inflammation is a target of medical treatment for lower urinary tract symptoms associated with benign prostatic hyperplasia.

PURPOSE: To review the role of a persistent prostatic inflammatory status (PIS) in the development and progression of benign prostatic hyperplasia (BPH) associated with lower urinary tract symptoms (LUTS) and which medical therapies approved for LUTS/BPH may reduce persistent PIS. METHODS: Literature search in PubMed up to July 2019. RESULTS: The cause of histologically defined persistent PIS or chronic prostatic inflammation is multifactorial. It is evident in many men with LUTS/BPH, particularly in older men and in men with a large prostate volume or more severe (storage) LUTS. Additionally, persistent PIS is associated with an increased risk of acute urinary retention and symptom worsening. Of medical therapies approved for LUTS/BPH, the current evidence for a reduction of persistent PIS is greatest for the hexanic extract of Serenoa repens (HESr). This treatment relieves LUTS to the same extent as α1-adrenoceptor antagonists and short-term 5α-reductase inhibitors. Limited evidence is available on the effect of other mainstream LUTS/BPH treatments on persistent PIS. CONCLUSIONS: Persistent PIS plays a central role in both the development and progression of LUTS/BPH. In men with LUTS/BPH who have a high chance of harbouring persistent PIS, HESr will not only improve LUTS, but also reduce (underlying) inflammation. Well-designed clinical studies, with a good level of evidence, are required to better evaluate the impact of BPH/LUTS medical therapies on persistent PIS.

Correction to: Inflammation is a target of medical treatment for lower urinary tract symptoms associated with benign prostatic hyperplasia.

The article "Inflammation is a target of medical treatment for lower urinary tract symptoms associated with benign prostatic hyperplasia", written by Cosimo De Nunzio, Andrea Salonia, Mauro Gacci and Vincenzo Ficarra was originally published electronically on the publisher's internet portal on 14 February 2020 without open access.

Head-to-head comparison between multiparametric MRI, the partin tables, memorial sloan kettering cancer center nomogram, and CAPRA score in predicting extraprostatic cancer in patients undergoing radical prostatectomy.

BACKGROUND: It is unclear whether clinical models including the Partin tables (PT), the Memorial Sloan Kettering Cancer Center nomogram (MSKCCn), and the cancer of the prostate risk assessment (CAPRA) can benefit from incorporating multiparametric magnetic resonance imaging (mpMRI) when staging prostate cancer (PCa). PURPOSE: To compare the accuracy of clinical models, mpMRI, and mpMRI plus clinical models in predicting stage ≥pT3 of PCa. STUDY TYPE: Prospective monocentric cohort study. POPULATION: Seventy-three patients who underwent radical prostatectomy between 2016-2018. FIELD STRENGTH/SEQUENCE: 3.0T using turbo spin echo (TSE) imaging, single-shot echoplanar diffusion-weighted imaging, and T1 -weighted high-resolution-isotropic-volume-examination (THRIVE) contrast-enhanced imaging. ASSESSMENT: We calculated the probability of extraprostatic extension (EPE) using the PT and MSKCC, as well as the CAPRA score. Three readers with 2-8 years of experience in mpMRI independently staged PCa on imaging. STATISTICAL TESTS: Receiver operating characteristics analysis and logistic regression analysis to investigate the per-patient accuracy of mpMRI vs. clinical models vs. mpMRI plus clinical models in predicting stage ≥pT3. The alpha level was 0.05. RESULTS: Median probability for EPE and MSKCCn was 27.3% and 47.0%, respectively. Median CAPRA score was 3. Stage ≥pT3 occurred in 32.9% of patients. Areas under the curve (AUCs) were 0.62 for PT, 0.62 for MSKCCn, 0.64 for CAPRA, and 0.73-0.75 for mpMRI (readers 1-3) (P > 0.05 for all comparisons). Compared with mpMRI, the combination of mpMRI with PT or MSKCCn provided lower AUCs (P > 0.05 for all the readers), while the combination with CAPRA provided significantly higher (P < 0.05) AUCs in the case of readers 1 and 3. On multivariable analysis, mpMRI by reader 1 was the only independent predictor of stage ≥pT3 (odds ratio 7.40). DATA CONCLUSION: mpMRI was more accurate than clinical models and mpMRI plus clinical models in predicting stage ≥pT3, except for the combination of mpMRI and CAPRA in two out of three readers. LEVEL OF EVIDENCE: 2 Technical Efficacy: Stage 2 J. Magn. Reson. Imaging 2019;50:1604-1613.

Interreader agreement of PI-RADS v. 2 in assessing prostate cancer with multiparametric MRI: A study using whole-mount histology as the standard of reference.

BACKGROUND: Most studies assessing interreader agreement of Prostate Imaging Reporting and Data System v. 2 (PI-RADS v2) have used biopsy as the standard of reference, thus carrying the risk of not definitively noting all existent cancers. PURPOSE: To evaluate the interreader agreement in assessing prostate cancer (PCa) of PI-RADS v2, using whole-mount histology as the standard of reference. STUDY TYPE: Monocentric prospective cohort study. POPULATION: In all, 48 patients with biopsy-proven PCa referred for radical prostatectomy, undergoing staging multiparametric magnetic resonance imaging (mpMRI) between May 2016 to February 2017. FIELD STRENGTH/SEQUENCE: 3.0T system using high-resolution T2 -weighted imaging, diffusion-weighted imaging (echo-planar imaging with maximum b-value 2000 sec/mm2 ), and dynamic contrast-enhanced imaging (T1 -weighted high resolution isotropic volume examination; THRIVE) ASSESSMENT: Three radiologists blinded to final histology (2-8 years of experience) analyzed mpMRI images independently, scoring imaging findings in accordance with PI-RADS v2. On a per-lesion basis, we calculated overall and pairwise interreader agreement in assigning PI-RADS categories, as well as assessing malignancy with categories ≥3 or ≥4, and stage ≥pT3. STATISTICAL TESTS: Cohen's kappa analysis of agreement. RESULTS: On 71 lesions found on histology, there was moderate agreement in assigning PI-RADS categories to all cancers (k = 0.53) and clinically significant cancers (csPCa) (k = 0.47). Assessing csPCa with PI-RADS ≥4 cutoff provided higher agreement than PI-RADS ≥3 cutoff (k = 0.63 vs. 0.57). Interreader agreement was higher between more experienced readers, with the most experienced one achieving the highest cancer detection rate (0.73 for csPCa using category ≥4). There was substantial agreement in assessing stage ≥pT3 (k = 0.72). DATA CONCLUSION: We found moderate to substantial agreement in assigning the PI-RADS v2 categories and assessing the spectrum of cancers found on whole-mount histology, with category 4 as the most reproducible cutoff for csPCa. Readers' experience influenced interreader agreement and cancer detection rate. LEVEL OF EVIDENCE: 2 Technical Efficacy: Stage 2 J. Magn. Reson. Imaging 2019;49:546-555.

Three-dimensional virtual imaging of renal tumours: a new tool to improve the accuracy of nephrometry scores.

OBJECTIVES: To apply the standard PADUA and RENAL nephrometry score variables to three-dimensional (3D) virtual models (VMs) produced from standard bi-dimensional imaging, thereby creating three-dimensional (3D)-based (PADUA and RENAL) nephrometry scores/categories for the reclassification of the surgical complexity of renal masses, and to compare the new 3D nephrometry score/category with the standard 2D-based nephrometry score/category, in order to evaluate their predictive role for postoperative complications. MATERIALS AND METHODS: All patients with localized renal tumours scheduled for minimally invasive partial nephrectomy (PN) between September 2016 and September 2018 underwent 3D and 2D nephrometry score/category assessments preoperatively. After nephrometry score/category evaluation, all the patients underwent surgery. Chi-squared tests were used to evaluate the individual patients' grouping on the basis of the imaging tool (3D VMs and 2D imaging) used to assess the nephrometry score/category, while Cohen's κ coefficient was used to test the concordance between classifications. Receiver-operating characteristic curves were produced to evaluate the sensitivity and specificity of the 3D nephrometry score/category vs the 2D nephrometry score/category in predicting the occurrence of postoperative complications. A general linear model was used to perform multivariable analyses to identify predictors of overall and major postoperative complications. RESULTS: A total of 101 patients were included in the study. The evaluation of PADUA and RENAL nephrometry scores via 3D VMs showed a downgrading in comparison with the same scores evaluated with 2D imaging in 48.5% and 52.4% of the cases. Similar results were obtained for nephrometry categories (29.7% and 30.7% for PADUA risk and RENAL complexity categories, respectively). The 3D nephrometry score/category demonstrated better accuracy than the 2D nephrometry score/category in predicting overall and major postoperative complications (differences in areas under the curve for each nephrometry score/category were statistically significant comparing the 3D VMs with 2D imaging assessment). Multivariable analyses confirmed 3D PADUA/RENAL nephrometry category as the only independent predictors of overall (P = 0.007; P = 0.003) and major postoperative complications (P = 0.03; P = 0.003). CONCLUSIONS: In the present study, we showed that 3D VMs were more precise than 2D standard imaging in evaluating the surgical complexity of renal masses according to nephrometry score/category. This was attributable to a better perception of tumour depth and its relationships with intrarenal structures using the 3D VM, as confirmed by the higher accuracy of the 3D VM in predicting postoperative complications.

The Simplified PADUA REnal (SPARE) nephrometry system: a novel classification of parenchymal renal tumours suitable for partial nephrectomy.

OBJECTIVE: To simplify the original Preoperative Aspects and Dimensions Used for an Anatomical (PADUA) classification of renal tumours, generating a new system able to predict equally or better the risk of overall complications in patients undergoing partial nephrectomy (PN); and to test if the addition of the contact surface area (CSA) parameter improves the accuracy of the original PADUA and new Simplified PADUA REnal (SPARE) nephrometry classification systems. PATIENTS AND METHODS: We analysed the clinical records of 531 patients who underwent PN (open, laparoscopic and robot-assisted) for renal tumours at five tertiary academic referral centres from January 2014 to December 2016. The ability of each variable included in the PADUA classification to predict overall complications was tested using binary logistic regression analysis. The variables that were not statistically significant were excluded from the SPARE classification. In addition to the original PADUA and SPARE systems, another two models were generated adding tumour CSA. Receiver operating characteristic curve analysis was used to compare the ability of the four different models to predict overall complications. Binary logistic regression was used to perform both univariable and multivariable analyses looking for predictors of postoperative complications. Linear regression analysis was used to identify independent predictors of absolute change in estimated glomerular filtration rate (eGFR; ACE). RESULTS: The SPARE nephrometry score system including: (i) rim location, (ii) renal sinus involvement, (iii) exophytic rate, and (iv) tumour dimension; showed equal performance in comparison with the original PADUA score (area under the curve [AUC] 0.657 vs 0.664). Adding tumour CSA to the original PADUA (AUC 0.661) or to the SPARE (AUC 0.658) scores did not increase the accuracy of either system to predict overall complications. The SPARE system (odds ratio 1.2, 95% confidence interval 1.1-1.3) was an independent predictor of postoperative overall complications. Age (P < 0.001), body mass index (P < 0.001), Charlson Comorbidity Index (P = 0.02), preoperative eGFR (P < 0.001), and tumour CSA (P = 0.005) were independent predictors of ACE. Limitations include the retrospective design and the lack of central imaging review. CONCLUSIONS: The new SPARE score is comprised of only four variables instead of the original six and its accuracy to predict overall complications is similar to that of the original PADUA score. Addition of tumour CSA was not associated with an increase in prognostic accuracy. The SPARE system could replace the original PADUA score to evaluate the complexity of tumours suitable for PN.

Tumour contact surface area as a predictor of postoperative complications and renal function in patients undergoing partial nephrectomy for renal tumours.

OBJECTIVES: To evaluate the ability of original tumour contact surface area (CSA) to predict postoperative complications and renal function impairment in a series of patients who underwent elective partial nephrectomy (PN) for renal masses. MATERIALS AND METHODS: We analysed the clinical records of 531 consecutive patients who underwent elective PN because of a suspicion of kidney cancer at five academic, high-volume centres between January 2014 and December 2016. Each participating centre evaluated prospectively the radiological images to evaluate the CSA and to assign a PADUA score. Several expert surgeons performed the surgical procedures in each participating centre. Binary logistic regression was used to perform both univariable and multivariable analyses to identify predictors of postoperative complications. Linear regression analysis was used to identify independent predictors of absolute change in estimated glomerular filtration rate (eGFR; ACE). RESULTS: The median (interquartile range) CSA value was 14.2 (7.4-25.1) cm2 . A total of 349 tumours (65.7%) had a CSA ≤ 20 cm2 and the remaining 182 (34.3%) had a CSA > 20 cm2 . PNs were performed using an open approach in 237 (44.6%) cases, a pure laparoscopic approach in 152 cases (28.6%), and a robot-assisted approach in the remaining 142 cases (26.7%). Multivariable analyses found that only age (odds ratio [OR] 1.037, 95% confidence interval [CI] 1.018-1.057) and PADUA score (OR 1.289, 95%CI 1.132-1.469) were independent predictors of postoperative complications. Tumour CSA (OR 1.020, 95%CI 1.010-1.030) was found to be an independent predictor of postoperative complications only when PADUA score was removed from the model. Age (from -0.639 to -0.306; P < 0.001); body mass index (from 0.267 to 1.076; P = 0.001), age-adjusted Charlson score (from -3.193 to -0.259; P = 0.02), preoperative eGFR value (from -0.939 to -0.862; P < 0.001) and tumour CSA (from -0.260 to -0.048; P = 0.005) were found to be independent predictors of ACE. CONCLUSIONS: Tumour CSA is an independent predictor of postoperative renal function. Conversely, at multivariable analysis, PADUA score outperformed tumour CSA to predict postoperative complications after PN. The complexity of The Leslie et al. formula for calculating tumour CSA is a potential limitation with regard to its diffusion and application in clinical practice.

Nomogram for predicting the likelihood of postoperative surgical complications in patients treated with partial nephrectomy: a prospective multicentre observational study (the RECORd 2 project).

OBJECTIVE: To identify meaningful predictors and to develop a nomogram of postoperative surgical complications in patients treated with partial nephrectomy (PN). PATIENTS AND METHODS: We prospectively evaluated 4308 consecutive patients who had surgical treatment for renal tumours, between 2013 and 2016, at 26 Italian urological centres (RECORd 2 project). A multivariable logistic regression for surgical complications was performed. A nomogram was created from the multivariable model. Internal validation processes were performed using bootstrapping with 1000 repetitions. RESULTS: Overall, 2584 patients who underwent PN were evaluated for the final analyses. The median (interquartile [IQR]) American Society of Anesthesiologists (ASA) score was 2 (2-3). In all, 72.4% of patients had clinical T1a (cT1a) stage tumours. The median (IQR) Preoperative Aspects and Dimensions Used for an Anatomical (PADUA) score was 7 (6-8). Overall, 34.3%, 27.7%, 38% of patients underwent open PN (OPN), laparoscopic PN (LPN), and robot-assisted PN (RAPN). Overall and major postoperative surgical complications were recorded in 10.2% and 2.5% of patients, respectively. At multivariable analysis, age, ASA score, cT2 vs cT1a stage, PADUA score, preoperative anaemia, OPN and LPN vs RAPN, were significant predictive factors of postoperative surgical complications. We used these variables to construct a nomogram for predicting the risk of postoperative surgical complications. At decision curve analysis, the nomogram led to superior outcomes for any decision associated with a threshold probability of >5%. CONCLUSION: Several clinical predictors have been associated with postoperative surgical complications after PN. We used this information to develop and internally validate a nomogram to predict such risk.