Publications by authors named "Giulia Primiceri"

19 Publications

  • Page 1 of 1

Bladder cancer: do we need contrast injection for MRI assessment of muscle invasion? A prospective multi-reader VI-RADS approach.

Eur Radiol 2020 Nov 19. Epub 2020 Nov 19.

Department of Neuroscience, Imaging and Clinical Sciences, "G. d'Annunzio" University, Via Luigi Polacchi 11, 66100, Chieti, Italy.

Objectives: (1) To investigate whether a contrast-free biparametric MRI (bp-MRI) including T2-weighted images (T2W) and diffusion-weighted images (DWI) can be considered an accurate alternative to the standard multiparametric MRI (mp-MRI), consisting of T2, DWI, and dynamic contrast-enhanced (DCE) imaging for the muscle-invasiveness assessment of bladder cancer (BC), and (2) to evaluate how the diagnostic performance of differently experienced readers is affected according to the type of MRI protocol.

Methods: Thirty-eight patients who underwent a clinically indicated bladder mp-MRI on a 3-T scanner were prospectively enrolled. Trans-urethral resection of bladder was the gold standard. Two sets of images, set 1 (bp-MRI) and set 2 (mp-MRI), were independently reviewed by four readers. Descriptive statistics, including sensitivity and specificity, were calculated for each reader. Receiver operating characteristic (ROC) analysis was performed, and the areas under the curve (AUCs) were calculated for the bp-MRI and the standard mp-MRI. Pairwise comparison of the ROC curves was performed.

Results: The AUCs for bp- and mp-MRI were respectively 0.91-0.92 (reader 1), 0.90 (reader 2), 0.95-0.90 (reader 3), and 0.90-0.87 (reader 4). Sensitivity was 100% for both protocols and specificity ranged between 79.31 and 89.66% and between 79.31 and 83.33% for bp-MRI and mp-MRI, respectively. No significant differences were shown between the two MRI protocols (p > 0.05). No significant differences were shown accordingly to the reader's experience (p > 0.05).

Conclusions: A bp-MRI protocol consisting of T2W and DWI has comparable diagnostic accuracy to the standard mp-MRI protocol for the detection of muscle-invasive bladder cancer. The experience of the reader does not significantly affect the diagnostic performance using VI-RADS.

Key Points: • The contrast-free MRI protocol shows a comparable accuracy to the standard multiparametric MRI protocol in the bladder cancer muscle-invasiveness assessment. • VI-RADS classification helps non-expert radiologists to assess the muscle-invasiveness of bladder cancer. • DCE should be carefully interpreted by less experienced readers due to inflammatory changes representing a potential pitfall.
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http://dx.doi.org/10.1007/s00330-020-07473-6DOI Listing
November 2020

Radical penectomy, a compromise for life: results from the PECAD study.

Transl Androl Urol 2020 Jun;9(3):1306-1313

Department of Urology, ASL 2 Abruzzo, Hospital "S. Pio da Pietrelcina", Vasto, Italy.

Background: The use of organ sparing strategies to treat penile cancer (PC) is currently supported by evidence that has indicated the safety, efficacy and benefit of this surgery. However, radical penectomy still represents up to 15-20% of primary tumor treatments in PC patients. The aim of the study was to evaluate efficacy in terms of overall survival (OS) and disease-free survival (DFS) of radical penectomy in PC patients.

Methods: Data from a retrospective multicenter study (PEnile Cancer ADherence study, PECAD Study) on PC patients treated at 13 European and American urological centers (Hospital "Sant'Andrea", Sapienza University, Roma, Italy; "G.D'Annunzio" University, Chieti and ASL 2 Abruzzo, Hospital "S. Pio da Pietrelcina", Vasto, Italy; Department of Genitourinary Oncology, Moffitt Cancer Center, Tampa, FL, USA; Hospital of Budapest, Hungary; Department of Emergency and Organ Transplantation, Urology and Andrology Unit II, University of Bari, Italy; Hospital "Spedali Civili", Brescia, Italy; Istituto Europeo di Oncologia, University of Milan, Milan, Italy; University of Modena & Reggio Emilia, Modena, Italy; Hospital Universitario La Paz, Madrid, Spain; Ceara Cancer Institute, Fortaleza, Brazil; Virginia Commonwealth University, Richmond, VA, USA; Aristotle University of Thessaloniki, Thessaloniki, Greece; Maria Skłodowska-Curie Memorial Cancer Center, Warsaw, Poland) between 2010 and 2016 were used. Medical records of patients who specifically underwent radical penectomy were reviewed to identify main clinical and pathological variables. Kaplan-Meier method was used to estimate 1- and 5-year OS and DFS.

Results: Of the entire cohort of 425 patients, 72 patients (16.9%) treated with radical penectomy were extracted and were considered for the analysis. The median age was 64.5 (IQR, 57.5-73.2) years. Of all, 41 (56.9%) patients had pT3/pT4 and 31 (43.1%) pT1/pT2. Moreover, 36 (50.0%) were classified as pN1-3 and 5 (6.9%) M1. Furthermore, 61 (84.7%) had a high grade (G2-G3) with 6 (8.3%) positive surgical margins. The 1- and 5-year OS rates were respectively 73.3% and 59.9%, while the 1- and 5-year DFS rates were respectively 67.3% and 35.1%.

Conclusions: PC is an aggressive cancer particularly in more advanced stage. Overall, more than a third of patients do not survive at 5 years and more than 60% report a disease recurrence, despite the use of a radical treatment.
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http://dx.doi.org/10.21037/tau.2020.04.04DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7354339PMC
June 2020

Conservative management of urinary incontinence following robot-assisted radical prostatectomy.

Minerva Urol Nefrol 2020 Oct 20;72(5):555-562. Epub 2020 May 20.

European Association of Urology - European Society of Residents in Urology (EAU-ESRU).

Introduction: Robotic assisted radical prostatectomy (RARP) is getting more and more popular becoming the most common radical prostatectomy technique. Unfortunately, a not negligible proportion of patients in whom RARP is performed experience urinary incontinence. We aimed to systematically review the current literature evidence on urinary incontinence conservative treatment after RARP.

Edidence Aquisition: A systematic literature review search using PubMed (Medline), Scopus, and Web of Science databases was performed in December 2019. PRISMA guidelines have been adopted. Population consisted of patients with urinary incontinence after RARP (P), conservative intervention was considered of interest (I). No comparator was considered mandatory (C). Outcomes of interest were the recovery of continence and quality of life (O).

Evidedence Synthesis: Six studies were included. Four of them investigated the use of pelvic floor muscle training (PFMT). PFMT improved pelvic muscle strength. Continence recovery was faster when guided PFMT was adopted. Moreover, two studies tested the effect of solifenacin on urinary incontinence. One of them, a randomized clinical trial, failed to show shorter time to continence in solifenacin group compared to placebo.

Conclusions: The use of pads is associated with a detrimental effect on quality of life thus active treatments for UI post-RARP are warranted. PFMT has the main advantage to shorten the time for recovery. The use of solifenacin seems to not offer striking advantages in UI following RARP. Future studies should focus on testing the efficacy of these treatments when used after robotic vs. open radical prostatectomy.
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http://dx.doi.org/10.23736/S0393-2249.20.03782-0DOI Listing
October 2020

Could Bladder Multiparametric MRI Be Introduced in Routine Clinical Practice? Role of the New VI-RADS Score: Results From a Prospective Study.

Clin Genitourin Cancer 2020 10 13;18(5):409-415.e1. Epub 2020 Mar 13.

Department of Medical, Oral and Biotechnological Sciences, G. d'Annunzio University of Chieti, Urology Unit, SS Annunziata Hospital, Chieti, Italy.

Background: The Vesical Imaging Reporting and Data System (VI-RADS) was recently introduced as a standardized approach to reporting multiparametric magnetic resonance imaging (mpMRI) for bladder cancer. We aimed to prospectively analyze its routine use and its diagnostic performance in discriminating non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC).

Patients And Methods: A total of 38 patients with diagnosis of suspect bladder cancer at cystoscopy underwent bladder mpMRI before transurethral resection of the bladder (TURB). Bladder tumors were categorized according to the VI-RADS. After TURB, the VI-RADS score was compared with histological report for each lesion separately. Receiving operating characteristic and decision curve analyses were used to assess its accuracy and clinical utility.

Results: A total of 68 lesions were included, of which 7 (10.3%) were MIBC. The pooled accuracy was 90.0% (95% confidence interval [CI], 75.4%-98.7%). The best threshold was estimated as VI-RADS 4, showing a sensitivity of 85.7% (95% CI, 57.1%-100%) and a specificity of 86.9% (95% CI, 78.7%-95.1%). Decision curve analyses showed that using VI-RADS ≥4 improved the net benefit compared with any default strategy for threshold probabilities of MIBC up to ∼40%, which is a reasonable clinical threshold for planning further treatments.

Conclusions: Our prospective study shows that the use of VI-RADS as a standardized reporting method is appealing and could be considered in clinical practice owing to its high accuracy.
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http://dx.doi.org/10.1016/j.clgc.2020.03.002DOI Listing
October 2020

New Antiandrogen Compounds Compared to Docetaxel for Metastatic Hormone Sensitive Prostate Cancer: Results from a Network Meta-Analysis.

J Urol 2020 04 5;203(4):751-759. Epub 2019 Nov 5.

Department of Medical, Oral and Biotechnological Sciences, G. d'Annunzio University of Chieti, Chieti, Italy.

Purpose: Docetaxel represent the standard of care in patients with metastatic, hormone sensitive prostate cancer. However, androgen receptor axis targeted therapies have also been shown to be effective. We aimed to analyze findings in randomized controlled trials investigating first-line treatment for hormone sensitive prostate cancer.

Materials And Methods: We systematically reviewed the literature according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) criteria and the PICO (Population, Intervention, Comparator, Outcomes) methodology. Outcomes of interest were overall and progression-free survival, and the rate of high grade adverse events.

Results: No treatment was superior to docetaxel in terms of overall survival. However, abiraterone (HR 0.89, 95% CI 0.76-1.05), enzalutamide (HR 0.90, 95% CI 0.69-1.19) and apalutamide (HR 0.90, 95% CI 0.67-1.22) showed nonstatistically significant lower overall mortality rates than docetaxel. Abiraterone (HR 0.71, 95% CI 0.59-0.86), enzalutamide (HR 0.61, 95% CI 0.49-0.75) and apalutamide (HR 0.74, 95% CI 0.57-0.95) also showed statistically significant lower disease progression rates than docetaxel. Furthermore, abiraterone (OR 0.83, 95% CI 0.56-1.21) showed no statistically significant lower rate of high grade adverse events compared to docetaxel. Finally, enzalutamide (OR 0.56, 95% CI 0.35-0.92) and apalutamide (OR 0.44, 95% CI 0.24-0.79) showed statistically significant lower rates of high grade adverse events compared to docetaxel.

Conclusions: Treatment with androgen receptor axis targeted therapies combined with androgen deprivation therapy in patients with hormone sensitive prostate cancer did not offer a statistically significant advantage in overall survival compared to the standard, docetaxel. However, it was associated with a lower disease progression rate. Moreover, apalutamide and enzalutamide offer a better safety profile.
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http://dx.doi.org/10.1097/JU.0000000000000636DOI Listing
April 2020

A drug safety evaluation of abiraterone acetate in the treatment of prostate cancer.

Expert Opin Drug Saf 2019 Sep;18(9):759-767

a Department of Urology, SS. Annunziata Hospital , Chieti , Italy.

: To evaluate the safety profile characteristics of abiraterone acetate (AA) in the treatment of metastatic prostate cancer (mPCa). : In this literature review the authors evaluate safety data from phase III trials investigating the combination of abiraterone acetate plus prednisone (AAP) in patients with metastatic prostate cancer. In particular, the aim was to clarify its toxicity profile, long-term exposure impact, and the correlation with general health-related quality of life (HRQoL). : Based on the studies reviewed, it appears that abiraterone acetate has favourable outcomes, is effective and well tolerated, mostly in asymptomatic or slightly symptomatic patients, and has recognised toxicity profile characteristics. Incidence of adverse events (AEs), such as mineralocorticoid- and corticosteroid-releated AEs, and hepatotoxicity is well known and widely described. Understanding the toxicity profile of AA could assist decision-making in clinical practice.
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http://dx.doi.org/10.1080/14740338.2019.1648428DOI Listing
September 2019

Safety of on- vs off-clamp robotic partial nephrectomy: per-protocol analysis from the data of the CLOCK randomized trial.

World J Urol 2020 May 24;38(5):1101-1108. Epub 2019 Jul 24.

Urology Unit, Careggi Hospital, University of Florence, Florence, Italy.

Purpose: To compare the safety of on- vs off-clamp robotic partial nephrectomy (RAPN).

Methods: 302 patients with RENAL masses ≤ 10 were randomized to undergo on-clamp (150) vs off-clamp (152) RAPN (CLOCK trial-ClinicalTrials.gov NCT02287987) at seven institutions by one experienced surgeon per institution. Intra-operative data, complications, and positive surgical margins were compared.

Results: Due to a relevant rate of shift from the assigned treatment, the per-protocol analysis only was considered and the data from 129 on-clamp vs 91 off-clamp RAPNs analyzed. Tumor size (off-clamp vs on-clamp, 2.2 vs 3.0 cm, p < 0.001) and RENAL score (5 vs 6, p < 0.001) significantly differed. At univariate analysis, no differences were found regarding intra-operative estimated blood loss (off- vs on-clamp, 100 vs 100 ml, p = 0.7), post-operative complications rate (19% vs 26%, p = 0.2), post-operative anemia (Hb decrease > 2.5 g/dl 26% vs 27%, p = 0.9; transfusion rate 3.4% vs 6.3%, p = 0.5; re-intervention due to bleeding 1.1% vs 4%, p = 0.4), acute kidney injury (4% vs 6%, p = 0.8), and positive surgical margins (3.5% vs 8.2%, p = 0.1). At multivariate analysis accounting for tumor diameter and complexity, considering the on-clamp group as the reference category, a significant difference was noted in the off-clamp group exclusively for blood loss (OR 0.3, 95% CI 0.09-0.52, p = 0.008).

Conclusions: The on-clamp and off-clamp approaches for RAPN showed a comparable safety profile.
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http://dx.doi.org/10.1007/s00345-019-02879-4DOI Listing
May 2020

Predictors of the Transition from Off to On Clamp Approach during Ongoing Robotic Partial Nephrectomy: Data from the CLOCK Randomized Clinical Trial.

J Urol 2019 07 7;202(1):62-68. Epub 2019 Jun 7.

Careggi Hospital, University of Florence , Florence , Italy.

Purpose: We sought to identify predictive factors of the transition from off clamp to on clamp robotic partial nephrectomy following an intraoperative decision.

Materials And Methods: In the multicenter, randomized, prospective CLOCK (CLamp vs Off Clamp the Kidney during robotic partial nephrectomy) trial 152 and 149 of the 301 patients with a localized renal mass were assigned to undergo off clamp and on clamp robotic partial nephrectomy, respectively. Surgery was done at a total of 7 referral institutions by 1 surgeon per institution. A localized renal mass was defined as having a R.E.N.A.L. (radius, exophytic/endophytic, nearness to collecting system or sinus, anterior/posterior, location relative to polar lines, hilar) score less than 10. Surgeons had similar experience with at least 100 previous robotic partial nephrectomies. All patients underwent a preoperative and a 6-month renal scan. The current study deals with one of the secondary end points of the trial, comparing cases finalized as clampless (off robotic partial nephrectomy group) with those which were converted (shift robotic partial nephrectomy group).

Results: Of the 152 patients randomized to off clamp 61 (40%) were shifted to clamp with a median ischemia time of 15 minutes. In the shift robotic partial nephrectomy group the masses were larger (3.5 vs 2.2 cm) and more complex (R.E.N.A.L. score 7 vs 6). A significant association with transition was found for tumor diameter (OR 1.4) and the R.E.N.A.L. score continuously (OR 1.4) and when recoded in groups, including 4-no risk (referent OR 1), 5-6-low risk (OR 1.8), 7-8-intermediate risk (OR 3.6) and 9 or greater-high risk (OR 6.6). The shift robotic partial nephrectomy group had longer operative time, higher blood loss and increased performance of 2-layer renorrhaphy. No significant differences were noted in postoperative complications or renal function after 6 months.

Conclusions: The transition from off to on clamp robotic partial nephrectomy is associated with renal mass diameter and complexity. Under the specific conditions of the current trial no harm was related to this decision.
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http://dx.doi.org/10.1097/JU.0000000000000194DOI Listing
July 2019

The Effect of Institution Teaching Status on Perioperative Outcomes After Robotic Partial or Radical Nephrectomy.

J Endourol 2018 07 19;32(7):621-629. Epub 2018 Jun 19.

1 Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center , Montreal, Canada .

Objectives: To test rates over time of robotic partial and radical nephrectomy (RPN and RRN) at teaching vs nonteaching institutions and to examine associated complication rates and length of stay.

Materials And Methods: Within the National Inpatient Sample (2008-2013), after stratification according to institutional teaching status, we examined the rates of robotic, open, and laparoscopic PN and RN. Subsequently, we tested complication rates and length of stay associated with RPN or RRN according to institutional teaching status. We relied on estimated annual percentage change (EAPC) with the least squares linear regression to test temporal trends and on multivariable logistic regression (MLR) and Poisson regression models to test complication rates and length of stay.

Results: Overall, 4070 and 1683 RPN and RRN were identified. In MLR, RPN rates were lower at teaching vs nonteaching institutions (odds ratio [OR]: 0.79, p < 0.001). RPN increased at similar rates over time at teaching and nonteaching institutions (EAPC: +32.1% and +30.1%, all p < 0.05). In MLR, RRN rates were similar at teaching and nonteaching institutions (p: 0.4). RRN rate increase over time was of similar magnitude at teaching vs nonteaching institutions (EAPC: +35.5% and +43.0%, all p < 0.05). RPN at teaching institutions yielded higher genitourinary complication rates (OR: 1.46, p: 0.01). RRN at teaching institutions resulted in lower respiratory complications (OR: 0.66, p: 0.04) and shorter length of stay (rate ratio [RR]: 0.93, p: 0.01), but higher intraoperative complication rates (OR: 3.39, p: 0.04).

Conclusion: Despite statistically significant differences in rates of RPN use, according to the institutional teaching status and despite statistically significant difference in selected complications, no meaningful differences distinguish teaching vs nonteaching institution when RPN and RRN are considered.
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http://dx.doi.org/10.1089/end.2018.0025DOI Listing
July 2018

Trifecta and Pentafecta Rates After Robotic Assisted Partial Nephrectomy: Comparative Study of Patients with Renal Masses <4 and ≥4 cm.

J Laparoendosc Adv Surg Tech A 2018 Jul 1;28(7):799-803. Epub 2018 Mar 1.

2 Department of Urology, SS. Annunziata Hospital, "G. D'Annunzio" University of Chieti , Chieti, Italy .

Objectives: Robotic-assisted partial nephrectomy (RAPN) is preferred to radical nephrectomy because it guarantees superior functional outcomes in patients with small renal masses (RMs). Only a few studies so far have evaluated the feasibility of RAPN for the treatment of RM ≥4 cm. The aim of this study is to evaluate the safety and feasibility of RAPN based on a comparison of trifecta and pentafecta rates for RMs ≥4 cm.

Material And Methods: We retrospectively analyzed prospectively collected data from an institutional database of patients undergoing RAPN from September 2013 to November 2016. Demographic and perioperative data were collected and statistically analyzed. Pentafecta is defined as achievement of trifecta (negative surgical margins, no postoperative complications, and warm ischemia time ≤25 minutes) with the addition of two other variables, namely, over 90% estimated glomerular filtration rate preservation and no chronic kidney disease stage progression 1 year after surgery.

Results: Overall, 123 patients underwent RAPN. Of those, 38 (30.9%) had RMs ≥4 cm. Trifecta was achieved in 72.9% of patients with RMs <4 cm and in 44.7% of those with ≥4 cm, whereas pentafecta was achieved by 23.5% of patients with RMs <4 cm and by 10.5% of those with RMs ≥4 cm. No significant predictive factors were found in connection with trifecta, whereas only one was found in connection with pentafecta, namely, age (odds ratio: 0.91; 95% confidence interval 0.85-0.98; P = .01).

Conclusions: RAPN may be considered a feasible and safe surgical approach ensuring good functional outcome even for patients with RMs ≥4 cm. Pentafecta rates after RAPN were comparable between RMs <4 and ≥4 cm in diameter.
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http://dx.doi.org/10.1089/lap.2017.0657DOI Listing
July 2018

Survival after Cytoreductive Nephrectomy in Metastatic Non-clear Cell Renal Cell Carcinoma Patients: A Population-based Study.

Eur Urol Focus 2019 May 8;5(3):488-496. Epub 2017 Dec 8.

Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center, Montreal, QC, Canada; Department of Urology, University of Montreal Health Centre, Montreal, QC, Canada.

Background: The benefit of cytoreductive nephrectomy (CNT) for cancer-specific mortality (CSM)-free survival is unclear in contemporary metastatic non-clear cell renal cell carcinoma (non-ccmRCC) patients.

Objective: To assess the role of CNT in non-ccmRCC patients.

Design, Setting, And Participants: Within Surveillance, Epidemiology, and End Results registry (2001-2014), we identified patients with non-ccmRCC.

Intervention: CNT versus no CNT in non-ccmRCC patients.

Outcome Measurements And Statistical Analysis: Multivariable logistic regression, cumulative incidence, competing-risks regression models, incremental survival benefit (ISB), conditional survival, and landmark analyses were performed. Sensitivity analyses focused on histological subtypes and most contemporary patients (2010-2014).

Results And Limitations: Of 851 patients with non-ccmRCC, 67.6% underwent CNT. In multivariable logistic regression, year of diagnosis in contemporary (p<0.001) and intermediate (p=0.008) tertiles, as well as age ≥75 yr (p<0.001) yielded lower CNT rates. Cumulative incidence showed 2-yr CSM of 52.6% versus 77.7%, respectively, after CNT versus no CNT. CSM after CNT versus no CNT was invariably lower in all histologic subtypes and in contemporary patients. Multivariable competing-risks regression models predicting CSM favored CNT (hazard ratio [HR]: 0.38, confidence interval: 0.30-0.47, p<0.001) in all patients and in all subgroups defined by histologic subtypes (HR: 0.14-0.43, all p≤0.02), as well as in contemporary patients (HR: 0.32, p<0.001). The ISB analyses yielded statistically significant and clinically meaningful CSM-free survival benefit of +3 mo after CNT versus no CNT in individuals with observed CSM-free survival ≤24 mo. The 2-yr CSM-free survival increased from baseline of 46.1% versus 19.4% (Δ=26.7%, p<0.001) to 70.3% versus 54.4% (Δ=15.9%, p=0.005) after CNT versus no CNT, in patients that survived 12 mo, respectively. Landmark analyses rejected bias favoring CNT. Data were retrospective.

Conclusions: CSM is lower after CNT for non-ccmRCC in all histologic subtypes and in contemporary patients except for unproven ISB in collecting duct patients. This observation should encourage greater CNT consideration in non-ccmRCC.

Patient Summary: Cytoreductive nephrectomy appears to improve survival in metastatic non-clear cell renal cell carcinoma, but it is used infrequently.
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http://dx.doi.org/10.1016/j.euf.2017.11.012DOI Listing
May 2019

Bladder Neck Contracture After Endoscopic Surgery for Benign Prostatic Obstruction: Incidence, Treatment, and Outcomes.

Curr Urol Rep 2017 Aug 9;18(10):79. Epub 2017 Aug 9.

Department of Urology, ASL02 Abruzzo, Via dei Vestini, 66100, Chieti, Italy.

Purpose Of Review: In recent years, new endoscopic techniques have been developed to reduce the morbidity of transurethral resection of the prostate. Nonetheless, complications are still frequently encountered and bladder neck contracture (BNC) is a well-described complication after endoscopic surgery for benign prostatic obstruction (BPO). Our aim is to review and discuss the contemporary incidence, the relevant treatment strategies, and their outcomes.

Recent Findings: Findings suggest that BNC is a common complication with an acceptably low incidence but can range in complexity. Most contractures were usually managed successfully with conservative measures; nevertheless, in patients with refractory BNC, various valuable management strategies were employed with different kinds of success and re-treatment rates. In consideration of these challenging possibilities, the treatment of BNC requires a tailored approach with patient-specific management that can range from simple procedures to complex surgical reconstruction.
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http://dx.doi.org/10.1007/s11934-017-0723-6DOI Listing
August 2017

Impact of diagnostic ureteroscopy on intravesical recurrence in patients undergoing radical nephroureterectomy for upper tract urothelial cancer: a systematic review and meta-analysis.

BJU Int 2017 09 19;120(3):313-319. Epub 2017 Jul 19.

Division of Urology, Virginia Commonwealth University, Richmond, VA, USA.

Aim of this study was to analyse the association between the use of diagnostic ureteroscopy (URS) and the development of intravesical recurrence (IVR) in patients undergoing radical nephroureterectomy (RNU) for high-risk upper tract urothelial carcinoma. A systematic review of the published data was performed up to December 2016, using multiple search engines to identify eligible studies. A formal meta-analysis was conducted of studies comparing patients who underwent URS before RNU with those who did not. Hazard ratios (HRs), with their 95% confidence intervals (CIs), from each study were used to calculate pooled HRs. Pooled estimates were calculated using a fixed-effects or random-effects model according to heterogeneity. Statistical analyses were performed using RevMan, version 5. Seven studies were included in the systematic review, but only six of these were deemed fully eligible for meta-analysis. Among the 2 382 patients included in the meta-analysis, 765 underwent diagnostic URS prior to RNU. All examined studies were retrospective, and the majority examined Asian populations. The IVR rate ranged from 39.2% to 60.7% and from 16.7% to 46% in patients with and without prior URS, respectively. In the pooled analysis, a statistically significant association was found between performance of URS prior to RNU and IVR (HR 1.56, 95% CI 1.33-1.88; P < 0.001). There was no heterogeneity in the observed outcomes, according to the I statistic of 2% (P = 0.40). Within the intrinsic limitations of this type of analysis, these findings suggest a significant association between the use of diagnostic URS and higher risk of developing IVR after RNU. Further research in this area should be encouraged to further investigate the possible causality behind this association and it potential clinical implications.
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http://dx.doi.org/10.1111/bju.13935DOI Listing
September 2017

Life-threatening complications after ureteroscopy for urinary stones: survey and systematic literature review.

Minerva Urol Nefrol 2017 Oct 1;69(5):421-431. Epub 2017 Feb 1.

Department of Urology, ASL2 Abruzzo, Chieti, Italy.

Introduction: Retrograde ureteroscopy (URS) has become a common procedure for the management of urinary stones. Although its efficacy and safety are well known, the literature about major complications is still poor. This study highlighted some cases of life-threatening complications after semi-rigid ureteroscopy (s-URS) or flexible ureteroscopy (f-URS).

Evidence Acquisition: Experienced endourologists (more than 75 cases/year in the last 3 years) we enrolled, and a survey was performed asking to review their series and report the cases encumbered by major complications (Clavien-Dindo IIIb-IV grade). A literature search was also conducted in the Medline (PubMed) and Cochrane Libraries databases in July, 2016 to identify all studies reporting the presence of major complications in patients underwent URS procedures. A PubMed search was performed using the following key words in combination: "kidney injury," "ureteroscopy," "nephrectomy," "life-threatening," "urinary stones," "complications."

Evidence Synthesis: Eleven urologists reported on 12 major complications (4 after s-URS, 8 after f-URS). Eight patients developed a kidney injury, 1 an arteriovenous fistula, 2 a ureter avulsion and 1 acute sepsis. Six patients underwent open nephrectomy, two surgical repair, one open pyeloplasty, one coil artery embolization and two superselective artery embolization.

Conclusions: Guidelines and clinical practice give useful recommendations about intraoperative safety and prevention of life-threatening events. The careful postoperative observation and the surgical active treatment of this complications play a key role in reducing morbidity, kidney loss and mortality. This study encourages a strict and active care of patients, supports a routine reporting of complications, and highlights the need for systematic use of standardized classification systems.
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http://dx.doi.org/10.23736/S0393-2249.17.02787-4DOI Listing
October 2017

High Neutrophil-to-lymphocyte Ratio as Prognostic Factor in Patients Affected by Upper Tract Urothelial Cancer: A Systematic Review and Meta-analysis.

Clin Genitourin Cancer 2017 06 29;15(3):343-349.e1. Epub 2016 Dec 29.

Department of Urology, ASL Abruzzo 2, Chieti, Italy.

Given the increasing interest in the possible role of the neutrophil-to-lymphocyte ratio (NLR) as an easily available oncologic marker for upper tract urothelial cancer (UTUC), we sought to quantify the prognostic effect of this biomarker and assess its consistency in UTUC. A systematic review of the published data was performed up to May 2016 using multiple search engines (PubMed, Ovid, and Scopus) to identify eligible comparative studies. A formal meta-analysis was performed for studies comparing patients with a high and those with a low NLR before surgical treatment of UTUC to determine whether the NLR is an independent predictor of survival. Pooled estimates were calculated using a fixed-effects model if no significant heterogeneity was identified. Alternatively, a random-effects model was used when significant heterogeneity was detected. For continuous outcomes, the weighted mean difference was used as a summary measure. For binary variables, the odds ratio or risk ratio was calculated with the 95% confidence intervals (CIs). Statistical analyses were performed using RevMan, version 5. Six studies with 1710 patients were included. A high NLR was associated with poorer oncologic outcomes in patients affected by UTUC, in particular in terms of overall survival (hazard ratio [HR], 1.97; 95% CI, 1.27-3.04; P = .002) and recurrence-free survival (HR, 1.53; 95% CI, 1.19-1.96; P = .0009) but not cancer-specific survival (HR, 1.25; 95% CI, 0.29-5.41; P = .77). Current evidence suggests that the NLR might have an independent role as a prognostic factor in patients affected by UTUC undergoing surgical treatment. The NLR potentially represents an easily available measurement of prognosis; however, it requires validation in larger prospective studies.
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http://dx.doi.org/10.1016/j.clgc.2016.12.027DOI Listing
June 2017

Bladder neck contracture after surgery for benign prostatic obstruction.

Minerva Urol Nefrol 2017 Apr 1;69(2):133-143. Epub 2016 Dec 1.

Robotic Unit, Department of Urology, ASL Abruzzo 2, SS. Annunziata Hospital, Chieti, Italy.

Introduction: Over the last few decades, numerous surgical procedures have been proposed to treat lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). However, all are characterized by a certain rate of treatment failure due to bladder neck contracture (BNC). Treatment of secondary BNC appears to be challenging. The main purpose of this review is to evaluate current published knowledge on this topic.

Evidence Acquisition: The MEDLINE/PubMed database was searched for all original articles published between 2000 and 2016 analyzing the incidence, prevalence and management of BNC as a post-operative complication following surgical treatment of LUTS/BPH. Prospectively designed studies, and those with prospectively maintained databases and/or rigorous inclusion and exclusion criteria were included. Given the lack of prospective studies examining treatment options for BNC, retrospective studies were also included in this section.

Evidence Synthesis: Thirty-four studies were included. The huge heterogeneity of patients, gland characteristics, surgical strategies and follow-up procedures limited the overall quality of results. BNC incidence after surgery for LUTS/BPH ranges from 0% to 9.6%. Given the dearth of well-designed studies, it seems rational to leave the choice of treatment procedure to the specialist's own decision.

Conclusions: BNC incidence varies greatly depending on the examined cohorts, with only few precautionary measures available for prevention. Treatment is challenging and it seems reasonable to leave the choice of BNC treatment technique to the surgeon's own judgement.
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http://dx.doi.org/10.23736/S0393-2249.16.02777-6DOI Listing
April 2017

The Clinical Use of the Neutrophil to Lymphocyte Ratio (NLR) in Urothelial Cancer: A Systematic Review.

Clin Genitourin Cancer 2016 12 22;14(6):473-484. Epub 2016 Apr 22.

Department of Urology, Robotic Unit, ASL Abruzzo 2, "SS. Annunziata" Hospital, Chieti, Italy.

The neutrophil to lymphocyte ratio (NLR) is an inflammatory index that has been considered as a potential prognostic factor in human cancer. The aim of this study was to evaluate the available evidence regarding the NLR as a prognostic value in patients affected by urothelial cancer. This literature review, including papers on NLR in urothelial cancers, was done on PubMed/Medline and Cochrane libraries in November 2015. The selection of the articles followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses process. Twenty-three of 99 articles fulfilled all the inclusion criteria, including data on 6240 patients affected by urothelial cancers. Overall, cancer-specific, and recurrence-free survival were evaluated as the main oncological outcomes. There was significant heterogeneity among studies, and the majority of studies were of poor quality. Overall, NLR was considered as a prognostic marker in 87.5%, 80%, and 60% of the studies on upper tract urothelial cancer, urothelial bladder cancer, and metastatic and advanced disease, respectively. The NLR cut-off value ranged between 2 and 5. A high NLR was associated with worse overall, cancer-specific, and recurrence-free survival. NLR is a widely available, easy-to-collect, costless, prognostic marker in urothelial cancers. Its clinical use still remains under investigation, especially for the need for cut-off values, particularly in different subsets of patients.
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http://dx.doi.org/10.1016/j.clgc.2016.04.008DOI Listing
December 2016

The Use of Haemostatic Agents and Sealants for the Prevention of Lymphocele After Urological Surgery: A Review of the Literature.

Surg Technol Int 2015 Nov;27:45-50

Biomedical Science, Università degli Studi "G.D'Annunzio", Chieti-Pescara, Chieti, Italy.

Background: Despite the continuous technological innovation in urological surgery procedures, lymphocele represents one of the major and more frequent complications both in tumour and transplant surgery. Haemostatic agents have been used hypothesizing a beneficial effect on the prevention of lymphoceles. We aimed to review the published literature to establish whether haemostatic agents and sealants are an effective option for lymphocele prevention following urological procedure.

Materials And Methods: An extensive PubMed search was performed including the following keywords: "lymphocele", "lymphocele prevention", "fibrin glue", "collagen patch", "fibrin patch", and "haemostatic material". The search, which collected data until January 2000, was restricted to the full text available articles in the English language and human studies.

Results: Our research identified 64 articles, among these only four fulfilled the inclusion criteria. A total of 133 patients underwent surgery and were treated with haemostatic agents and/or sealants to reduce the lymphoceles formation. The mean age was 56.1 years. A negligible variability in study design and in results and complication reporting is common. The 6.45% of patients treated with haemostatic biomaterials developed lymphocele. The rate difference of lymphoceles formation and recurrence between patient groups treated with sealant than in the controls groups is small (6.45% vs 6.88%).

Conclusions: The evidences presented in the examined studies are only preliminary and insufficient to draw significant conclusions. A major, multicentre, randomized controlled trial is strongly needed.
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November 2015