A. Porreca

Analysis of radical cystectomy and urinary diversion complications with the Clavien classification system in an Italian real life cohort

INTRODUCTION Standardized methods of reporting complications after radical cystectomy (RC) and urinary diversions (UD) are necessary to evaluate the morbidity associated with this operation to evaluate the modified Clavien classification system (CCS) in grading perioperative complications of RC and UD in a real life cohort of patients with bladder cancer. MATERIALS AND METHODS A consecutive series of patients treated with RC and UD from April 2011 to March 2012 at 19 centers in Italy was evaluated. Complications were recorded according to the modified CCS. Results were presented as complication rates per grade. Univariate and binary logistic regression analysis were used for statistical analysis. RESULTS RESULTS AND LIMITATIONS 467 patients were enrolled. Median age was 70 years (range 35-89). UD consisted in orthotopic neobladder in 112 patients, ileal conduit in 217 patients and cutaneous ureterostomy in 138 patients. 415 complications were observed in 302 patients and were classified as Clavien type I (109 patients) or II (220 patients); Clavien type IIIa (45 patients), IIIb (22 patients); IV (11 patients) and V (8 patients). Patients with cutaneous ureterostomy presented a lower rate (8%) of CCS type ≥IIIa (p = 0.03). A longer operative time was an independent risk factor of CCS ≥III (OR: 1.005; CI: 1.002-1.007 per minute; p = 0.0001). CONCLUSIONS In our study, RC is associated with a significant morbidity (65%) and a reduced mortality (1.7%) when compared to previous experiences. The modified CCS represents an easily applicable tool to classify the complications of RC and UD in a more objective and detailed way.

Active surveillance for clinically localized renal tumors: An updated review of current indications and clinical outcomes

The widespread use of abdominal imaging has led to an increasing detection of small renal masses, and approximately 20–30% of those tumors will prove to be benign, with low metastatic potential if not immediately treated. In elderly or comorbid patients diagnosed with small renal masses, competing cause mortality seems to exceed cancer‐specific mortality at short‐ and intermediate‐term follow up. In these cases, surgery might represent an overtreatment, and an expectant management, such as active surveillance, might be proposed. According to the current available evidence, active surveillance is a safe and reasonable option for patients with renal tumors ≤4 cm (cT1a) and short life expectancy. A few studies with short‐term follow up reported the preliminary results of active surveillance even in cT1b–cT2 tumors, with acceptable risk of disease progression and mortality, even if this approach should be considered in this setting only for highly‐selected and well‐informed patients. Furthermore, surveillance protocols can be proposed in selected patients with uncomplicated benign tumors, such as angiomyolipomas, in which active surveillance should be considered the initial standard management. At present, reliable clinical predictors of a tumors growth rate and aggressiveness are not available. Renal tumor biopsy is useful in the clinical work‐up of patients who are candidates for active surveillance, in order to improve patient selection based on tumor histological characterization. Despite the proof of safety offered by expectant management for small renal masses in selected patients, further prospective studies with longer follow up are required in order to confirm the indications and long‐term oncological outcomes of active surveillance protocols for renal tumors.

The R.E.N.A.L. Nephrometric Nomogram Cannot Accurately Predict Malignancy or Aggressiveness of Small Renal Masses Amenable to Partial Nephrectomy

INTRODUCTION/BACKGROUND The prediction of histology of SRM could be essential for their management. The RNN is a statistical tool designed to predict malignancy or high grading of enhancing renal masses. In this study we aimed to perform an external validation of the RNN in a cohort of patients who received a PN for SRM. MATERIALS AND METHODS This was a multicentric study in which the data of 506 consecutive patients who received a PN for cT1a SRM between January 2010 and January 2013 were analyzed. For each patient, the probabilities of malignancy and aggressiveness were estimated preoperatively using the RNN. The performance of the RNN was evaluated according to receiver operating characteristic (ROC) curve, calibration plot, and decision curve analyses. RESULTS The area under the ROC curve for malignancy was 0.57 (95% confidence interval [CI], 0.51-0.63; P = .031). The calibration plot showed that the predicted probability of malignancy had a bad concordance with observed frequency (Brier score = 0.17; 95% CI, 0.15-0.19). Decision curve analysis confirmed a poor clinical benefit from use of the system. The estimated area under the ROC curve for high-grade prediction was 0.57 (95% CI, 0.49-0.66; P = .064). The calibration plot evidenced a bad concordance (Brier score = 0.15; 95% CI, 0.13-0.17). Decision curve analysis showed the lack of a remarkable clinical usefulness of the RNN when predicting aggressiveness. CONCLUSIONS The RNN cannot accurately predict histology in the setting of cT1a SRM amenable to PN.

The biopsy Gleason score 3+4 in a single core does not necessarily reflect an unfavourable pathological disease after radical prostatectomy in comparison with biopsy Gleason score 3+3: looking for larger selection criteria for active surveillance candidates

Background:To assess whether the addition of clinical Gleason score (Gs) 3+4 to the Prostate Cancer Research International: Active Surveillance (PRIAS) criteria affects pathologic results in patients who are potentially suitable for active surveillance (AS) and to identify possible clinical predictors of unfavourable outcome.Methods:Three hundred and twenty-nine men who underwent radical prostatectomy with complete clinical and follow-up data and who would have fulfilled the inclusion criteria of the PRIAS protocol at the time of biopsy except for the addition of biopsy Gs=3+4 and with at least 10 cores taken have been evaluated. One experienced genitourinary pathologist selected those with real Gs=3+3 and 3+4 in only one core according to the 2005 International Society of Urological Pathology criteria. The primary end point was the proportion of unfavourable outcome (nonorgan confined disease or Gs⩾4+3). Logistic regressions explored the association between preoperative characteristics and the primary end point.Results:Two hundred and four patients were evaluated and 46 (22.5%) patients harboured unfavourable disease at final pathology. After a median follow-up of 73.5 months, there was no cancer-specific death, and 4 (2.0%) patients had biochemical relapse. There were no significant differences in terms of high Gs, locally advanced disease, unfavourable disease and biochemical relapse-free survival among patients with clinical Gs=3+3 vs Gs=3+4. At multivariable analysis, the presence of atypical small acinar proliferation (ASAP) and lower number of core taken were independently associated with a higher risk of unfavourable disease.Conclusion:The inclusion of Gs=3+4 in patients suitable to AS does not enhance the risk of unfavourable disease after radical prostatectomy. Additional factors such as number of cores taken and the presence of ASAP should be considered in patients suitable for AS.

In-bore MRI-guided Prostate Biopsy Using an Endorectal Nonmagnetic Device: A Prospective Study of 70 Consecutive Patients

Micro‐Abstract In a cohort of 70 consecutive patients with suspected prostate cancer and ≥ 1 suspicious area at the preliminary multiparametric magnetic resonance imaging study, in‐bore endorectal magnetic resonance imaging‐guided biopsy demonstrated a high detection rate, especially for clinical significant tumors and lesions located in the central and anterior regions of the gland, with a very low number of cores needed and a negligible incidence of complications. Introduction: We investigated the diagnostic performance of in‐bore endorectal magnetic resonance imaging‐guided biopsy (MRI‐GB) with a 1.5‐T MRI scanner using a 32‐channel coil in patients with suspected prostate cancer (PCa). Patients and Methods: Seventy patients with ≥ 1 suspicious area found on the preliminary multiparametric MRI scan were enrolled. The index lesion was defined as the lesion with the greatest Prostate Imaging Reporting and Data System, version 2 (PIRADS‐v2), score. MRI‐GBs were performed with a nonmagnetic biopsy device, needle guide, and titanium double‐shoot biopsy gun with dedicated software for needle tracking. Clinically significant PCa was defined as the presence of Gleason score ≥ 7 in the biopsy specimen. Results: Seventy index lesions were scheduled for MRI‐GB. The median PIRADS‐v2 score and the median number of cores per patient was 4 of 5 (interquartile range, 3‐5) and 2 (interquartile range, 1‐3), respectively. The PCa detection rate was 45.7%. Of the 70 patients, 24 (75%) had clinically significant PCa, with a significant correlation between the PIRADS‐v2 score and the Gleason score in the MRI‐GB cores (r = 0.839; 95% confidence interval, 0.535‐0.951; P = .003). According to the PIRADs‐v2 scheme, the proportion of PCa in the central and anterior regions of the gland was greater in the entire population and in the subgroup of patients with a history of negative transrectal ultrasound‐guided biopsy findings (P ≤ .01 for all). On multivariate analysis, a PIRADS‐v2 score of 5 of 5 correlated significantly with the likelihood of PCa at biopsy (hazard ratio, 4.69; 95% confidence interval, 0.92‐23.74; P = .04). No major complications were recorded. Conclusion: MRI‐GB has a high detection rate for PCa, especially for lesions located in the central and anterior regions of the prostate.

Evaluating the predictive accuracy and the clinical benefit of a nomogram aimed to predict survival in node‐positive prostate cancer patients: External validation on a multi‐institutional database

To assess the predictive accuracy and the clinical value of a recent nomogram predicting cancer‐specific mortality‐free survival after surgery in pN1 prostate cancer patients through an external validation.

MP49-02 PERIOPERATIVE MORBIDITY OF CLAMP VS OFF-CLAMP ROBOTIC PARTIAL NEPHRECTOMY: PRELIMINARY RESULTS FROM A MULTICENTRE RANDOMIZED CLINICAL TRIAL (THE CLOCK STUDY)

INTRODUCTION AND OBJECTIVES: To assess the significance of mannitol used as renal protective agent during nephronsparing surgery (NSS) on renal functional outcomes after NSS. METHODS: A prospective, randomized, placebo-controlled, double-blind, phase 3 trial (ClinicalTrials.gov identifier NCT01606787) designed to detect a 5% difference between treatment arms with a power of 90%. Patients were randomized 1:1 to receive mannitol (12.5 g) or normal saline solution placebo intravenously within 30 min prior to renal vascular clamping. Eligibility criteria included age >18 yr, renal artery clamping during NSS, and preoperative estimated glomerular filtration rate (eGFR) >45 mL/min/1.73m. Intraoperatively, a standardized fluid management algorithm was used to maintain hemodynamic stability and urine output 0.5 mL/kg/h. Postoperatively, eGFR was obtained at 6 wk and 6 mo. A renal scan was obtained pre operatively and at the 6-mo endpoint. An ANCOVA model was used to assess the differences in eGFR at 6 wk and 6 mo, and in renal scan at 6 mo after NSS. Differences in grade 3-5 complications were assessed using Fisher0s exact test. At the interim analysis on the first 88 patients, the O0Brien-Fleming stopping boundaries requiring a significance level of 0.0031 were not met (p 1⁄4 0.6). RESULTS: A total of 105 patients per treatment arm were enrolled. After excluding 11 patients (7 in the placebo and 4 in the mannitol arm) who did not undergo NSS; 2 patients (1 in each arm) converted to radical nephrectomy, and 1 patient from the mannitol arm who never received the study drug, 98 and 101 patients in the placebo and mannitol arms, respectively, were evaluated. Median age was 56 yr (interquartile range [IQR] 48, 63) and 60 yr (IQR 50, 66) in the placebo and mannitol arm, respectively. Comparing placebo to the mannitol arm, the adjusted difference of 0.2 eGFR units at 6 mo after NSS was not significant (95% confidence interval [CI] -3.1, 3.5; p1⁄4 0.9). The adjusted difference of -2.6 eGFR units at 6 wk after NSS was not significant (95% CI -5.8, 0.7; p 1⁄4 0.12). No significant differences were detected between treatment arms in median split function on 6-mo renal scan (difference -1.7; 95% CI -3.8, 0.4; p 1⁄4 0.11), or in grade 3-5 complication rates within 90 days of NSS (difference 3.2%; 95% CI -4.1%, 11%; p 1⁄4 0.4). CONCLUSIONS: This randomized prospective trial provides evidence against the use of mannitol as renal protective agent during NSS since no clinical or statistically significant advantage to the use of intravenous mannitol in patients undergoing NSS was found.

MRI Displays the Prostatic Cancer Anatomy and Improves the Bundles Management Before Robot-Assisted Radical Prostatectomy

OBJECTIVES To evaluate the impact of multiparametric magnetic0 resonance imaging (mpMRI) to guide the nerve-sparing (NS) surgical plan in prostate cancer (PCa) patients referred to robot-assisted radical prostatectomy (RARP). METHODS One hundred thirty-seven consecutive PCa patients were submitted to RARP between September 2016 and February 2017 at two high-volume European centers. Before RARP, each patient was referred to 1.5T or 3T mpMRI. NS was recorded as Grade 1, Grade 2, Grade 3, and Grade 4 according to Tewari and colleagues classification. A preliminary surgical plan to determinate the extent of NS approach was recorded based on clinical data. The final surgical plan was reassessed after mpMRI revision. The appropriateness of surgical plan change was considered based on the presence of extracapsular extension or positive surgical margins (PSMs) at level of neurovascular bundles area at final pathology. Furthermore, we analyzed a control group during the same period of 166 PCa patients referred to RARP in both institutions without preoperative mpMRI to assess the impact of the use of mpMRI on the surgical margins. RESULTS Considering 137 patients with preoperative mpMRI, the mpMRI revision induced the main surgeon to change the NS surgical plan in 46.7% of cases on patient-based and 56.2% on side-based analysis. The surgical plan change results equally assigned between the direction of more radical and less radical approach both on patient-based (54.7% vs 54.3%) and on side-based levels (50% vs 50%), resulting an overall appropriateness of 75%. Moreover, patients staged with mpMRI revealed significant lower overall PSMs compared with control group with no mpMRI (12.4% vs 24.1%; p ≤ 0.01). CONCLUSIONS mpMRI induces robotic surgeons to change the surgical plan in almost half of individuals, thus tailoring the NS approach, without compromising the oncologic outcomes. Compared to patients treated without mpMRI, the use of preoperative mpMRI can significantly reduce the overall PSMs.

Predicting survival in node-positive prostate cancer after open, laparoscopic or robotic radical prostatectomy: A competing risk analysis of a multi-institutional database.

To investigate cancer‐specific mortality and other‐cause mortality in prostate cancer patients with nodal metastases.

State‐of‐the‐art imaging techniques in the management of preoperative staging and re‐staging of prostate cancer

We aimed to review the current state‐of‐the‐art imaging methods used for primary and secondary staging of prostate cancer, mainly focusing on multiparametric magnetic resonance imaging and positron‐emission tomography/computed tomography with new radiotracers. An expert panel of urologists, radiologists and nuclear medicine physicians with wide experience in prostate cancer led a PubMed/MEDLINE search for prospective, retrospective original research, systematic review, meta‐analyses and clinical guidelines for local and systemic staging of the primary tumor and recurrence disease after treatment. Despite magnetic resonance imaging having low sensitivity for microscopic extracapsular extension, it is now a mainstay of prostate cancer diagnosis and local staging, and is becoming a crucial tool in treatment planning. Cross‐sectional imaging for nodal staging, such as computed tomography and magnetic resonance imaging, is clinically useless even in high‐risk patients, but is still suggested by current clinical guidelines. Positron‐emission tomography/computed tomography with newer tracers has some advantage over conventional images, but is not cost‐effective. Bone scan and computed tomography are often useless in early biochemical relapse, when salvage treatments are potentially curative. New imaging modalities, such as prostate‐specific membrane antigen positron‐emission tomography/computed tomography and whole‐body magnetic resonance imaging, are showing promising results for early local and systemic detection. Newer imaging techniques, such as multiparametric magnetic resonance imaging, whole‐body magnetic resonance imaging and positron‐emission tomography/computed tomography with prostate‐specific membrane antigen, have the potential to fill the historical limitations of conventional imaging methods in some clinical situations of primary and secondary staging of prostate cancer.