237 results on '"Claps F"'
Search Results
152. Diagnosis of prostate cancer with magnetic resonance imaging in men treated with 5-alpha-reductase inhibitors.
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Falagario UG, Lantz A, Jambor I, Busetto GM, Bettocchi C, Finati M, Ricapito A, Luzzago S, Ferro M, Musi G, Totaro A, Racioppi M, Carbonara U, Checcucci E, Manfredi M, D'Aietti D, Porcaro AB, Nordström T, Björnebo L, Oderda M, Soria F, Taimen P, Aronen HJ, Perez IM, Ettala O, Marchioni M, Simone G, Ferriero M, Brassetti A, Napolitano L, Carmignani L, Signorini C, Conti A, Ludovico G, Scarcia M, Trombetta C, Claps F, Traunero F, Montanari E, Boeri L, Maggi M, Del Giudice F, Bove P, Forte V, Ficarra V, Rossanese M, Mucciardi G, Pagliarulo V, Tafuri A, Mirone V, Schips L, Antonelli A, Gontero P, Cormio L, Sciarra A, Porpiglia F, Bassi P, Ditonno P, Boström PJ, Messina E, Panebianco V, De Cobelli O, and Carrieri G
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- Male, Humans, Aged, Cohort Studies, 5-alpha Reductase Inhibitors therapeutic use, Magnetic Resonance Imaging methods, Oxidoreductases, Image-Guided Biopsy methods, Prostate-Specific Antigen, Prostatic Neoplasms diagnostic imaging, Prostatic Neoplasms drug therapy
- Abstract
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., (© 2023. The Author(s).)
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- 2023
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153. Personalised indocyanine-guided lymphadenectomy for prostate cancer: a randomised clinical trial.
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de Pablos-Rodríguez P, Claps F, Rebez G, Vidal Crespo N, Gómez-Ferrer Á, Mascarós JM, Collado Serra A, Caltrava Fons A, Rubio-Briones J, Casanova Ramon Borja J, and Ramírez Backhaus M
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- Male, Humans, Prostate-Specific Antigen, Androgen Antagonists, Lymphatic Metastasis, Lymph Node Excision adverse effects, Lymph Node Excision methods, Pelvis surgery, Prostatectomy adverse effects, Prostatectomy methods, Prostatic Neoplasms pathology
- Abstract
Objectives: To study the safety and efficacy of a personalised indocyanine-guided pelvic lymph node dissection (PLND) against extended PLND (ePLND) during radical prostatectomy (RP)., Patients and Methods: Patients who were candidates for RP and lymphadenectomy, with intermediate- or high-risk prostate cancer (PCa) according to the National Comprehensive Cancer Network guidelines, were enrolled in this randomised clinical trial. Randomisation was made 1:1 to indocyanine green (ICG)-PLND (only ICG-stained LNs) or ePLND (obturator fossa, external, internal, and common iliac and presacral LNs). The primary endpoint was the complication rate within 3 months after RP. Secondary endpoints included: rate of major complications (Clavien-Dindo Grade III-IV), time to drainage removal, length of stay, percentage of patients classified as pN1, number of LNs removed, number of metastatic LNs, rate of patients with undetectable prostate-specific antigen (PSA), biochemical recurrence (BCR)-free survival, and rate of patients with androgen-deprivation therapy at 24 months., Results: A total of 108 patients were included with a median follow-up of 16 months. In all, 54 were randomised to ICG-PLND and 54 to ePLND. The postoperative complication rate was higher in the ePLND (70%) vs the ICG-PLND group (32%) (P < 0.001). Differences between major complications in both groups were not statically significant (P = 0.7). The pN1 detection rate was higher in the ICG-PLND group (28%) vs the ePLND group (22%); however, this difference was not statistically significant (P = 0.7). The rate of undetectable PSA at 12 months was 83% in the ICG-PLND vs 76% in the ePLND group, which was not statistically significant. Additionally, there were no statistically significant differences in BCR-free survival between groups at the end of the analysis., Conclusions: Personalised ICG-guided PLND is a promising technique to stage patients with intermediate- and high-risk PCa properly. It has shown a lower complication rate than ePLND with similar oncological outcomes at short-term follow-up., (© 2023 BJU International.)
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- 2023
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154. Analysis of Bacterial Stent Colonization: The Role of Urine and Device Microbiological Cultures.
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Tulone G, Costanzo A, Pavan N, Giaimo R, Claps F, Fasciana TMA, Giammanco A, Bartoletti R, and Simonato A
- Abstract
In this study, we explored the incidence of double J (JJ) contamination of patients who underwent an endourological procedure for urinary stones and ureteral stenosis. We developed a prospective study between January 2019 and December 2021. Ninety-seven patients, 54 male and 43 female, were enrolled. Urine culture was taken during four steps: before stent insertion, a sample from selective renal pelvis catheterization, a sample two days after the JJ insertion and finally, after the stent removal procedure. At the time of the stent removal, 1 cm of proximal and distal ends were cut off and placed in the culture for bacterial evaluation. Cohen's kappa coefficient value (k) and concordance rates of microbiological culture results were evaluated. The study group comprised 56% of male patients. Proximal and distal stent cultures were positive in 81 and 78 patients. The concordance rate of microbiological cultures between proximal and distal double J stent is 88% (k 0.6). The most common pathogens isolated from urine and stent cultures were Enterococcus spp. in 52 cases and Klebsiella spp. in 27 cases.
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- 2023
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155. Arterioureteral fistula: An unusual cause of haematuria 10 years after the implantation of a synthetic iliac-femoral stent.
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Ongaro L, Rizzo M, Claps F, Runti O, Piasentin A, Trombetta C, and Liguori G
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- 2023
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156. BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer: Current Treatment Landscape and Novel Emerging Molecular Targets.
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Claps F, Pavan N, Ongaro L, Tierno D, Grassi G, Trombetta C, Tulone G, Simonato A, Bartoletti R, Mertens LS, van Rhijn BWG, Mir MC, and Scaggiante B
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- Humans, BCG Vaccine therapeutic use, Quality of Life, Urinary Bladder Neoplasms drug therapy, Carcinoma, Transitional Cell, Non-Muscle Invasive Bladder Neoplasms, Mycobacterium bovis
- Abstract
Urothelial carcinoma (UC), the sixth most common cancer in Western countries, includes upper tract urothelial carcinoma (UTUC) and bladder carcinoma (BC) as the most common cancers among UCs (90-95%). BC is the most common cancer and can be a highly heterogeneous disease, including both non-muscle-invasive (NMIBC) and muscle-invasive (MIBC) forms with different oncologic outcomes. Approximately 80% of new BC diagnoses are classified as NMIBC after the initial transurethral resection of the bladder tumor (TURBt). In this setting, intravesical instillation of Bacillus Calmette-Guerin (BCG) is the current standard treatment for intermediate- and high-risk patients. Unfortunately, recurrence occurs in 30% to 40% of patients despite adequate BCG treatment. Radical cystectomy (RC) is currently considered the standard treatment for NMIBC that does not respond to BCG. However, RC is a complex surgical procedure with a recognized high perioperative morbidity that is dependent on the patient, disease behaviors, and surgical factors and is associated with a significant impact on quality of life. Therefore, there is an unmet clinical need for alternative bladder-preserving treatments for patients who desire a bladder-sparing approach or are too frail for major surgery. In this review, we aim to present the strategies in BCG-unresponsive NMIBC, focusing on novel molecular therapeutic targets.
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- 2023
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157. Prognostic impact of variant histologies in urothelial bladder cancer treated with radical cystectomy.
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Claps F, van de Kamp MW, Mayr R, Bostrom PJ, Shariat SF, Hippe K, Bertz S, Neuzillet Y, Sanders J, Otto W, van der Heijden MS, Jewett MAS, Stöhr R, Zlotta AR, Trombetta C, Eckstein M, Mertens LS, Burger M, Soorojebally Y, Wullich B, Bartoletti R, Radvanyi F, Pavan N, Sirab N, Mir MC, Pouessel D, van der Kwast TH, Hartmann A, Lotan Y, Bussani R, Allory Y, and van Rhijn BWG
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- Humans, Prognosis, Cystectomy, Retrospective Studies, Urinary Bladder Neoplasms pathology, Carcinoma, Transitional Cell pathology
- Abstract
Objectives: To evaluate variant histologies (VHs) for disease-specific survival (DSS) in patients with invasive urothelial bladder cancer (BCa) undergoing radical cystectomy (RC)., Materials and Methods: We analysed a multi-institutional cohort of 1082 patients treated with upfront RC for cT1-4aN0M0 urothelial BCa at eight centres. Univariable and multivariable Cox' regression analyses were used to assess the effect of different VHs on DSS in overall cohort and three stage-based analyses. The stages were defined as 'organ-confined' (≤pT2N0), 'locally advanced' (pT3-4N0) and 'node-positive' (pTanyN1-3)., Results: Overall, 784 patients (72.5%) had pure urothelial carcinoma (UC), while the remaining 298 (27.5%) harboured a VH. Squamous differentiation was the most common VH, observed in 166 patients (15.3%), followed by micropapillary (40 patients [3.7%]), sarcomatoid (29 patients [2.7%]), glandular (18 patients [1.7%]), lymphoepithelioma-like (14 patients [1.3%]), small-cell (13 patients [1.2%]), clear-cell (eight patients [0.7%]), nested (seven patients [0.6%]) and plasmacytoid VH (three patients [0.3%]). The median follow-up was 2.3 years. Overall, 534 (49.4%) disease-related deaths occurred. In uni- and multivariable analyses, plasmacytoid and small-cell VHs were associated with worse DSS in the overall cohort (both P = 0.04). In univariable analyses, sarcomatoid VH was significantly associated with worse DSS, while lymphoepithelioma-like VH had favourable DSS compared to pure UC. Clear-cell (P = 0.015) and small-cell (P = 0.011) VH were associated with worse DSS in the organ-confined and node-positive cohorts, respectively., Conclusions: More than 25% of patients harboured a VH at time of RC. Compared to pure UC, clear-cell, plasmacytoid, small-cell and sarcomatoid VHs were associated with worse DSS, while lymphoepithelioma-like VH was characterized by a DSS benefit. Accurate pathological diagnosis of VHs may ensure tailored counselling to identify patients who require more intensive management., (© 2023 BJU International.)
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- 2023
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158. Sentinel Lymph Node Biopsy in Prostate Cancer: An Overview of Diagnostic Performance, Oncological Outcomes, Safety, and Feasibility.
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Rossin G, Zorzi F, De Pablos-Rodríguez P, Biasatti A, Marenco J, Ongaro L, Perotti A, Tulone G, Traunero F, Piasentin A, Gomez-Ferrer A, Zucchi A, Trombetta C, Simonato A, Rubio-Briones J, Bartoletti R, Ramírez-Backhaus M, and Claps F
- Abstract
Sentinel node biopsy (SNB) for prostate cancer (PCa) represents an innovative technique aimed at improving nodal staging accuracy. The routinary adoption of this procedure in patients undergoing radical prostatectomy (RP) might be crucial to identify candidates who could effectively benefit from extensive pelvic lymph nodal dissection (ePLND). Despite some promising results, SNB for PCa is still considered experimental due to the lack of solid evidence and procedural standardization. In this regard, our narrative review aimed to analyze the most recent literature in this field, providing an overview of both the diagnostic accuracy measures and the oncological outcomes of SNB.
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- 2023
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159. The Utility of Inflammatory Serum Markers in the Assessment of Perioperative Morbidity after Radical Cystectomy for Bladder Cancer.
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Claps F, Rossin G, van Rhijn BWG, Mir MC, Mertens LS, Ongaro L, Traunero F, Iachimovsky AI, Piasentin A, Vedovo F, Perotti A, Tulone G, Zucchi A, Liguori G, Simonato A, Bartoletti R, Trombetta C, and Pavan N
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- Humans, Male, Female, Reproducibility of Results, Morbidity, Biomarkers, Inflammation complications, Retrospective Studies, Postoperative Complications epidemiology, Postoperative Complications etiology, Postoperative Complications surgery, Cystectomy adverse effects, Urinary Bladder Neoplasms surgery
- Abstract
Background and Objectives : To date, sparse evidence exists about the impact of inflammatory serum markers in predicting perioperative complications after radical cystectomy (RC) for bladder cancer (BC). Here, we evaluated the role of the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (LMR), systemic immune-inflammation index (SII), C-reactive protein (CRP), and plasma fibrinogen in predicting perioperative morbidity and unplanned 30-days readmission after RC for BC. Materials and methods : We relied on a collaborative database of 271 patients who underwent open RC for cT1-4a N0 M0 BC between January 2012 and December 2022. Univariable and multivariable binomial logistic regression analyses were performed to assess the odds ratio (OR) with 95% confidence intervals (CI) testing the ability of each serum marker to predict postoperative complications (any-grade and major complications), and 30-days unplanned readmission. Results : The median age at RC was 73 yr (IQR 67-79). A total of 182 (67.2%) patients were male and the median BMI was 25.2 (IQR 23.2-28.4). Overall, 172 (63.5%) patients had a Charlson Comorbidity Index (CCI) greater than 2 points and 98 (36.2%) were current smokers at the time of RC. Overall, 233 (86.0%) patients experienced at least one complication after RC. Of these, 171 (63.1%) patients had minor complications (Clavien-Dindo grade 1-2) while 100 (36.9%) experienced major complications (Clavien-Dindo grade ≥ 3). According to multivariable analysis, current smoking status, high plasma fibrinogen, and preoperative anemia were independently associated with major complications (OR 2.10, 95%CI 1.15-4.90, p = 0.02), (OR 1.51, 95%CI 1.26-1.98, p = 0.09), and (OR 1.35, 95%CI 1.17-2.57, p = 0.03), respectively. Overall, 56 (20.7%) patients experienced a 30-days unplanned readmission. According to univariable analysis, high preoperative CRP and hyperfibrinogenemia were significantly associated with an increased risk of unplanned readmission (OR 2.15, 95%CI 1.15-4.16, p = 0.02; OR 2.18, 95%CI 1.13-4.44, p = 0.02, respectively). Conclusions : In our study, the preoperative immune-inflammation signature described by NLR, PLR, LMR, SII, and CRP showed a low reliability in predicting perioperative course after RC. Preoperative anemia and hyperfibrinogenemia were independent predictors of major complications. Further studies are pending in order to draw definitive conclusions.
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- 2023
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160. Right internal jugular vein access for central venous catheterization in a prone COVID-19 patient.
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Strumia A, Longo F, Schiavoni L, Martuscelli M, Claps F, Remore LM, Piliego C, Pascarella G, and Agrò FE
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- Humans, Jugular Veins diagnostic imaging, Brachiocephalic Veins diagnostic imaging, Ultrasonography, Interventional, Catheterization, Central Venous adverse effects, COVID-19
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- 2023
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161. The Search for the Optimal cut-off Value of p53-Immunohistochemistry to Predict Prognosis of Invasive Bladder Cancer: A Multi-Center, Multi-Laboratory Analysis.
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Mertens LS, Claps F, Mayr R, Hodgson A, Shariat SF, Hippe K, Neuzillet Y, Sanders J, Burger M, Pouessel D, Otto W, van der Kwast TH, Lotan Y, Allory Y, Downes MR, and van Rhijn BWG
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- Humans, Genes, p53, Immunohistochemistry, Prognosis, Cystectomy, Retrospective Studies, Tumor Suppressor Protein p53 genetics, Urinary Bladder Neoplasms diagnosis, Urinary Bladder Neoplasms surgery, Urinary Bladder Neoplasms genetics
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Introduction: Mutations in the TP53 gene are indicative of worse outcome in bladder cancer and are usually assessed by immunohistochemistry. To define p53-overexpression, a threshold of >10% is most commonly used (cut-off1). Recently, a novel cut-off (aberrant = 0% or ≥50%) (cut-off2) showed better correlation to clinical outcome. In this study, we evaluate the association between p53-immunohistochemistry cut-offs, clinico-pathological variables and disease-specific survival (DSS). Methods: Seven-hundred-fifty chemotherapy-naïve patients who underwent radical cystectomy were included (92% muscle-invasive bladder cancer. In addition to cut-off1 and cut-off2, a third cut-off (cut-off3) was determined based on the highest Youden-index value. Cut-off values were associated with clinico-pathological variables and FGFR3 mutation status. The Kaplan-Meier method was used to estimate DSS. Results: Aberrant p53-expression was found in 489 (65%) (cut-off1) and 466 (62%) (cut-off2) tumors. Cut-off3 was determined at 25% and aberrant p53-expression in 410 cases (55%) (cutoff3). p53-expression levels were significantly associated with higher pT-stage (cut-off1/2/3: P = 0.047, P = 0.006 and P = 0.0002, respectively), higher grade (all, P < 0.0001), and FGFR3 wild-type (cut-off1: P = 0.02, cut-offs2&3: P = 0.001). Median follow-up was 5.3 years (interquartile range, 4.0-6.0 years). p53-expression was not associated with DSS for any of the three cut-offs (cut-off1/2/3: P-log-rank = 0.566, 0.77 and 0.50, respectively). If we only considered locally advanced bladder cancer, results on DSS remained non-significant. Conclusion: This multi-center, multi-laboratory study showed that, regardless of the cut-off used, p53-immunohistochemistry did not enable selection of patients with worse outcome. Our results suggest that p53-immunohistochemistry alone is not suitable to guide clinical decision making after radical cystectomy.
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- 2023
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162. Prognosis of Primary Papillary Ta Grade 3 Bladder Cancer in the Non-muscle-invasive Spectrum.
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Beijert IJ, Hentschel AE, Bründl J, Compérat EM, Plass K, Rodríguez O, Subiela Henríquez JD, Hernández V, de la Peña E, Alemany I, Turturica D, Pisano F, Soria F, Čapoun O, Bauerová L, Pešl M, Bruins HM, Runneboom W, Herdegen S, Breyer J, Brisuda A, Calatrava A, Rubio-Briones J, Seles M, Mannweiler S, Bosschieter J, Kusuma VRM, Ashabere D, Huebner N, Cotte J, Mertens LS, Claps F, Masson-Lecomte A, Liedberg F, Cohen D, Lunelli L, Cussenot O, El Sheikh S, Volanis D, Côté JF, Rouprêt M, Haitel A, Shariat SF, Mostafid AH, Nieuwenhuijzen JA, Zigeuner R, Dominguez-Escrig JL, Hacek J, Zlotta AR, Burger M, Evert M, Hulsbergen-van de Kaa CA, van der Heijden AG, Kiemeney LALM, Soukup V, Molinaro L, Gontero P, Llorente C, Algaba F, Palou J, N'Dow J, Ribal MJ, van der Kwast TH, Babjuk M, Sylvester RJ, and van Rhijn BWG
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- Humans, Neoplasm Staging, Prognosis, Urinary Bladder pathology, Urinary Bladder Neoplasms diagnosis, Urinary Bladder Neoplasms therapy, Urinary Bladder Neoplasms pathology, Carcinoma diagnosis, Carcinoma pathology
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Background: Ta grade 3 (G3) non-muscle-invasive bladder cancer (NMIBC) is a relatively rare diagnosis with an ambiguous character owing to the presence of an aggressive G3 component together with the lower malignant potential of the Ta component. The European Association of Urology (EAU) NMIBC guidelines recently changed the risk stratification for Ta G3 from high risk to intermediate, high, or very high risk. However, prognostic studies on Ta G3 carcinomas are limited and inconclusive., Objective: To evaluate the prognostic value of categorizing Ta G3 compared to Ta G2 and T1 G3 carcinomas., Design, Setting, and Participants: Individual patient data for 5170 primary Ta-T1 bladder tumors from 17 hospitals were analyzed. Transurethral resection of the tumor was performed between 1990 and 2018., Outcome Measurements and Statistical Analysis: Time to recurrence and time to progression were analyzed using cumulative incidence functions, log-rank tests, and multivariable Cox-regression models with interaction terms stratified by institution., Results and Limitations: Ta G3 represented 7.5% (387/5170) of Ta-T1 carcinomas of which 42% were classified as intermediate risk. Time to recurrence did not differ between Ta G3 and Ta G2 (p = 0.9) or T1 G3 (p = 0.4). Progression at 5 yr occurred for 3.6% (95% confidence interval [CI] 2.7-4.8%) of Ta G2, 13% (95% CI 9.3-17%) of Ta G3, and 20% (95% CI 17-23%) of T1 G3 carcinomas. Time to progression for Ta G3 was shorter than for Ta G2 (p < 0.001) and longer than for T1 G3 (p = 0.002). Patients with Ta G3 NMIBC with concomitant carcinoma in situ (CIS) had worse prognosis and a similar time to progression as for patients with T1 G3 NMIBC with CIS (p = 0.5). Multivariable analyses for recurrence and progression showed similar results., Conclusions: The prognosis of Ta G3 tumors in terms of progression appears to be in between that of Ta G2 and T1 G3. However, patients with Ta G3 NMIBC with concomitant CIS have worse prognosis that is comparable to that of T1 G3 with CIS. Our results support the recent EAU NMIBC guideline changes for more refined risk stratification of Ta G3 tumors because many of these patients have better prognosis than previously thought., Patient Summary: We used data from 17 centers in Europe and Canada to assess the prognosis for patients with stage Ta grade 3 (G3) non-muscle-invasive bladder cancer (NMIBC). Time to cancer progression for Ta G3 cancer differed from both Ta G2 and T1 G3 tumors. Our results support the recent change in the European Association of Urology guidelines for more refined risk stratification of Ta G3 NMIBC because many patients with this tumor have better prognosis than previously thought., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)
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- 2023
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163. Proposal for a Two-Tier Re-classification of Stage IV/M1 domain of Renal Cell Carcinoma into M1 ("Oligometastatic") and M2 ("Polymetastatic") subdomains: Analysis of the Registry for Metastatic Renal Cell Carcinoma (REMARCC).
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Meagher MF, Mir MC, Minervini A, Kriegmair M, Heck M, Porpiglia F, Van Bruwaene S, Linares E, Hevia V, D'Anna M, Veccia A, Roussel E, Claps F, Palumbo C, Marchioni M, Afari J, Saitta C, Liu F, Rubio J, Campi R, Mari A, Amiel T, Checcucci E, Musquera M, Guruli G, Pavan N, Albersen M, Antonelli A, Klatte T, Autorino R, McKay RR, and Derweesh IH
- Abstract
Purpose: We hypothesized that two-tier re-classification of the "M" (metastasis) domain of the Tumor-Node-Metastasis (TNM) staging of Renal Cell Carcinoma (RCC) may improve staging accuracy than the current monolithic classification, as advancements in the understanding of tumor biology have led to increased recognition of the heterogeneous potential of metastatic RCC (mRCC)., Methods: Multicenter retrospective analysis of patients from the REMARCC (REgistry of MetAstatic RCC) database. Patients were stratified by number of metastases into two groups, M1 (≤3, "Oligometastatic") and M2 (>3, "Polymetastatic"). Primary outcome was overall survival (OS). Secondary outcomes were cancer-specific survival (CSS). Cox-regression and Kaplan-Meier (KMA) analysis were utilized for outcomes, and receiver operating characteristic analysis (ROC) was utilized to assess diagnostic accuracy compared to current "M" staging., Results: 429 patients were stratified into proposed M1 and M2 groups (M1 = 286/M2 = 143; median follow-up 19.2 months). Cox-regression revealed M2 classification as an independent risk factor for worsened all-cause mortality (HR=1.67, p=0.001) and cancer-specific mortality (HR=1.74, p<0.001). Comparing M1-oligometastatic vs. M2-polymetastatic groups, KMA revealed significantly higher 5-year OS (36% vs. 21%, p<0.001) and 5-year CSS (39% vs. 17%, p<0.001). ROC analyses comparing OS and CSS, for M1/M2 reclassification versus unitary M designation currently in use demonstrated improved c-index for OS (M1/M2 0.635 vs. unitary M 0.500) and CSS (M1/M2 0.627 vs. unitary M 0.500)., Conclusion: Subclassification of Stage "M" domain of mRCC into two clinical substage categories based on metastatic burden corresponds to distinctive tumor groups whose oncological potential varies significantly and result in improved predictive capability compared to current staging., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Meagher, Mir, Minervini, Kriegmair, Heck, Porpiglia, Van Bruwaene, Linares, Hevia, D’Anna, Veccia, Roussel, Claps, Palumbo, Marchioni, Afari, Saitta, Liu, Rubio, Campi, Mari, Amiel, Checcucci, Musquera, Guruli, Pavan, Albersen, Antonelli, Klatte, Autorino, McKay and Derweesh.)
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- 2023
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164. Peripherally central catheter insertion in a prone COVID-19 patient.
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Longo F, Strumia A, Schiavoni L, Martuscelli M, Claps F, Piliego C, Remore LM, and Agrò FE
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- Humans, COVID-19, Catheterization, Central Venous adverse effects, Central Venous Catheters, Catheterization, Peripheral
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- 2023
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165. External validation of yonsei nomogram predicting chronic kidney disease development after partial nephrectomy: An international, multicenter study.
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Abdel Raheem A, Landi I, Alowidah I, Capitanio U, Montorsi F, Larcher A, Derweesh I, Ghali F, Mottrie A, Mazzone E, De Naeyer G, Campi R, Sessa F, Carini M, Minervini A, Raman JD, Rjepaj CJ, Kriegmair MC, Autorino R, Veccia A, Mir MC, Claps F, Choi YD, Ham WS, Santok GD, Tadifa JP, Syling J, Furlan M, Simeone C, Bada M, Celia A, Carrión DM, Aguilera Bazan A, Ruiz CB, Malki M, Barber N, Hussain M, Micali S, Puliatti S, Ghaith A, Hagras A, Ghoneem AM, Eissa A, Alqahtani A, Rumaih A, Alwahabi A, Alenzi MJ, Pavan N, Traunero F, Antonelli A, Porcaro AB, Illiano E, Costantini E, and Rha KH
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- Humans, Middle Aged, Nomograms, Retrospective Studies, Nephrectomy methods, Glomerular Filtration Rate, Kidney Neoplasms pathology, Renal Insufficiency, Chronic surgery
- Abstract
Objective: To externally validate Yonsei nomogram., Methods: From 2000 through 2018, 3526 consecutive patients underwent on-clamp PN for cT1 renal masses at 23 centers were included. All patients had two kidneys, preoperative eGFR ≥60 ml/min/1.73 m2, and a minimum follow-up of 12 months. New-onset CKD was defined as upgrading from CKD stage I or II into CKD stage ≥III. We obtained the CKD-free progression probabilities at 1, 3, 5, and 10 years for all patients by applying the nomogram found at https://eservices.ksmc.med.sa/ckd/. Thereafter, external validation of Yonsei nomogram for estimating new-onset CKD stage ≥III was assessed by calibration and discrimination analysis., Results and Limitation: Median values of patients' age, tumor size, eGFR and follow-up period were 47 years (IQR: 47-62), 3.3 cm (IQR: 2.5-4.2), 90.5 ml/min/1.73 m2 (IQR: 82.8-98), and 47 months (IQR: 27-65), respectively. A total of 683 patients (19.4%) developed new-onset CKD. The 5-year CKD-free progression rate was 77.9%. Yonsei nomogram demonstrated an AUC of 0.69, 0.72, 0.77, and 0.78 for the prediction of CKD stage ≥III at 1, 3, 5, and 10 years, respectively. The calibration plots at 1, 3, 5, and 10 years showed that the model was well calibrated with calibration slope values of 0.77, 0.83, 0.76, and 0.75, respectively. Retrospective database collection is a limitation of our study., Conclusions: The largest external validation of Yonsei nomogram showed good calibration properties. The nomogram can provide an accurate estimate of the individual risk of CKD-free progression on long-term follow-up., (© 2022 The Japanese Urological Association.)
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- 2023
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166. Focus on the Use of Resveratrol in Bladder Cancer.
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Zucchi A, Claps F, Pastore AL, Perotti A, Biagini A, Sallicandro L, Gentile R, Caglioti C, Palazzetti F, and Fioretti B
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- Humans, Male, Resveratrol therapeutic use, Administration, Intravesical, Combined Modality Therapy, Urinary Bladder Neoplasms pathology
- Abstract
Bladder cancer is the most common tumor of the urinary system, with a high incidence in the male population. Surgery and intravesical instillations can eradicate it, although recurrences are very common, with possible progression. For this reason, adjuvant therapy should be considered in all patients. Resveratrol displays a biphasic dose response both in vitro and in vivo (intravesical application) with an antiproliferative effect at high concentrations and antiangiogenic action in vivo (intraperitoneal application) at a low concentration, suggesting a potential role for it in clinical management as an adjuvant to conventional therapy. In this review, we examine the standard therapeutical approach to bladder cancer and the preclinical studies that have investigated resveratrol in xenotransplantation models of bladder cancer. Molecular signals are also discussed, with a particular focus on the STAT3 pathway and angiogenic growth factor modulation.
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- 2023
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167. Procalcitonin as prognostic factor in patients with Fournier's gangrene.
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Ongaro L, Claps F, Rizzo M, Di Cosmo G, Traunero F, D'Andrea E, Garaffa G, Cai T, Zucchi A, Trombetta C, and Liguori G
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- Humans, Male, Middle Aged, Prognosis, Procalcitonin, Retrospective Studies, Severity of Illness Index, Fournier Gangrene diagnosis
- Abstract
Introduction: Fournier's Gangrene (FG) has still a mortality rate up to 45%. Several studies identified prognostic factors but there is a knowledge gap concerning procalcitonin (PCT) levels and mortality risk in FG. This study is aimed to assess the role of PCT as prognostic factor in FG., Materials and Methods: The medical records of 20 male FG patients admitted at the Department of Urology of "Cattinara" Hospital, University of Trieste between January 2019 and November 2020 were retrospectively reviewed. Clinical, demographic, microbiological data were collected. The Fournier's Gangrene Severity Index (FGSI) was calculated for each patient., Results: Thirteen (65%) of 20 patients survived. Median age was 58 years (IQR 51-88), 15 patients (75%) had a Charlson Comorbidity Index (CCI) score ⩾2, 1 (5%) equal to 0, 4 to 1 (20%). Median FGSI score was 6 (IQR 2-12) and median PCT 0.8 ng/ml (IQR 0.04-2.12). At multivariate analysis PCT levels >0.05 ng/ml were associated with an increased overall mortality risk (OR 2.14, CI 1.25-4.27, p = 0.002). CCI score ⩾2 (OR 1.51, CI 1.01-2.59, p = 0.04), Streptococcical etiology (OR 3.41, CI 2.49-4.61, p = 0.002) and FGSI score >9 (OR 1.41, CI 1.19-2.21, p = 0.004) were associated with unfavorable outcome., Conclusion: PCT might be a prognostic factor in FG. CCI and FGSI are useful tools in mortality risk stratification. Streptococcical etiology is associated with unfavorable outcome. Further larger clinical trials are pending.
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- 2023
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168. Reliability of nephrolithometric nomograms in patients treated with minimally invasive percutaneous nephrolithotomy: A precision study.
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Mazzon G, Claps F, Pavan N, Choong S, Zeng G, Wu W, Zhong J, Bada M, Pirozzi M, Vitale R, and Celia A
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Objectives: The study aimed to evaluate quality of nephrolithometric nomograms to predict stone-free rates (SFRs) and complication rates (CRs) in case of minimally invasive percutaneous nephrolithotomy (PNL). In the last decade, nomograms have been introduced to estimate the SFRs and CRs of PNL. However, no data are available regarding their reliability in case of utilization of miniaturized devices. Herein we present a prospective multicentric study to evaluate reliability of Guy's stone score (GSS), the stone size, tract length, obstruction, number of involved calyces, and essence of stone (S.T.O.N.E.) nephrolithometry score and Clinical Research Office of the Endourological Society (CROES) score in patients treated with minimally invasive PNL., Methods: We evaluated SFRs and CRs of 222 adult patients treated with miniaturized PNL. Patients were considered stone-free if no residual fragments of any size at post-operative unenhanced computed tomography scan. Patients demographics, SFRs, and CRs were reported and analyzed. Performances of nomograms were evaluated with the area under the curve (AUC)., Results: We included 222 patients, the AUCs of GSS, CROES score, and S.T.O.N.E. nephrolithometry score were 0.69 (95% confidence interval [CI] 0.61-0.78), 0.64 (95% CI 0.56-0.73), and 0.62 (95% CI 0.52-0.71), respectively. Regarding SFRs, at multivariate binomial logistic regression, only the GSS had significance with an odds ratio of 0.53 (95% CI 0.31-0.95, p =0.04). We did not find significant correlation with complications, with only a trend for GSS., Conclusion: This is the first study evaluating nomograms in miniaturized PNL. They still show good reliability; however, our data showed lower performances compared to standard PNL. We emphasize the need of further studies to confirm this trend. A dedicated nomogram for minimally invasive PNL may be necessary., Competing Interests: The authors declare no conflict of interest., (© 2022 Editorial Office of Asian Journal of Urology. Production and hosting by Elsevier B.V.)
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- 2023
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169. Double-Layered Hand-Sewn versus Stapled Intestinal Anastomosis in Patients Who Underwent Ileal Urinary Diversion in Radical Cystectomy: A Comparative and Cost Effective Study.
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Tulone G, Pavan N, Giannone S, Abrate A, Mannone P, Baiamonte D, Claps F, Giaimo R, Rossanese M, Ficarra V, and Simonato A
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- Humans, Cystectomy methods, Retrospective Studies, Cost-Benefit Analysis, Polyglactin 910, Anastomosis, Surgical methods, Urinary Bladder Neoplasms surgery, Urinary Diversion methods
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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., (© 2023 S. Karger AG, Basel.)
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- 2023
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170. Impact of the controlling nutritional status (CONUT) score on perioperative morbidity and oncological outcomes in patients with bladder cancer treated with radical cystectomy.
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Claps F, Mir MC, van Rhijn BWG, Mazzon G, Soria F, D'Andrea D, Marra G, Boltri M, Traunero F, Massanova M, Liguori G, Dominguez-Escrig JL, Celia A, Gontero P, Shariat SF, Trombetta C, and Pavan N
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- Humans, Nutritional Status, Retrospective Studies, Prognosis, Morbidity, Cystectomy, Urinary Bladder Neoplasms surgery
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Introduction and Objectives: To evaluate the impact of the Controlling Nutritional Status (CONUT) score on perioperative morbidity and oncological outcomes of bladder cancer (BC) patients treated with radical cystectomy (RC)., Materials and Methods: We retrospectively analyzed a multi-institutional cohort of 347 patients treated with RC for clinical-localized BC between 2005 and 2019. The CONUT-score was defined as an algorithm including serum albumin, total lymphocyte count, and cholesterol. Multivariable logistic regression analyses were performed to evaluate the ability of the CONUT-score to predict any-grade complications, major complications and 30 days readmission. Multivariable Cox' regression models were performed to evaluate the prognostic effect of the CONUT-score on recurrence-free survival (RFS), overall survival (OS), and cancer-specific survival (CSS)., Results: A cut-off value to discriminate between low and high CONUT-score was determined by calculating the receiver operating characteristic (ROC) curve. The area under the curve was 0.72 hence high CONUT-score was defined as ≥3 points. Overall, 112 (32.3%) patients had a high CONUT. At multivariable logistic regression analyses, high CONUT was associated with any-grade complications (OR 3.58, P = 0.001), major complications (OR 2.56, P = 0.003) and 30 days readmission (OR 2.39, P = 0.01). On multivariable Cox' regression analyses, high CONUT remained associated with worse RFS (HR 2.57, P < 0.001), OS (HR 2.37, P < 0.001) and CSS (HR 3.52, P < 0.001)., Conclusions: Poor nutritional status measured by the CONUT-score is independently associated with a poorer postoperative course after RC and is predictive of worse RFS, OS, and CSS. This simple index could serve as a comprehensive personalized risk-stratification tool identifying patients who may benefit from an intensified regimen of supportive cares., (Copyright © 2022 Elsevier Inc. All rights reserved.)
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- 2023
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171. Learning Curve for Endoscopic Combined Intra-Renal Surgery Using Vacuum-Assisted Device.
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Mazzon G, Claps F, Germinale F, Brusa D, Choong S, Caruso A, Pirozzi M, Antonelli A, Cerruto MA, and Celia A
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- Humans, Learning Curve, Prospective Studies, Treatment Outcome, Retrospective Studies, Kidney Calculi surgery, Nephrostomy, Percutaneous methods
- Abstract
Introduction: The aim of the study was to provide data related to endoscopic combined intra-renal surgery learning curve using minimally invasive techniques with vacuum-assisted devices. Minimal data exist on the learning curve for these techniques., Methods: We conducted a prospective study monitoring the training of a mentored surgeon learning ECIRS with vacuum assistance. We use varied parameters for improvements. After collection of peri-operative data, tendency lines and CUSUM analysis were used to investigate the learning curves., Results: 111 patients have been included. Guy's Stone Score 3 and 4 stones 51.3% of all cases. The mostly used percutaneous sheath was 16 Fr (87.3%). SFR was 78.4%. 52.3% patients were tubeless, and 38.7% achieved trifecta. High-degree complication rate was 3.6%. Operative time improved after 72 cases. We observed a decrease of complications throughout the case series, with improvement after 17 cases. In terms of trifecta, proficiency was reached after 53 cases. Proficiency seems achievable in a limited number of procedures, but results did not plateau. Higher number of cases might be necessary for excellence., Discussion: A surgeon learning ECIRS with vacuum assistance can obtain proficiency in 17-50 cases. The number of procedures required for excellence remains unclear. Exclusion of more complex cases might positively affect the training, reducing unnecessary complications., (© 2023 S. Karger AG, Basel.)
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- 2023
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172. Idiopathic Retroperitoneal Fibrosis: What Is the Optimal Clinical Approach for Long-Term Preservation of Renal Function?
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Giannese D, Moriconi D, Cupisti A, Zucchi A, Pastore AL, Simonato A, Mogorovich A, Claps F, and Bartoletti R
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- Humans, Prospective Studies, Quality of Life, Kidney physiology, Ureteral Obstruction surgery, Retroperitoneal Fibrosis drug therapy, Retroperitoneal Fibrosis surgery
- Abstract
Background: The aim of this study was to investigate the long-term effects of ureteral stenting and the exact timing of stent removal in favor of surgery in patients with idiopathic retroperitoneal fibrosis (IRF)., Summary: Medline research terms of "idiopathic retroperitoneal fibrosis" AND " medical therapy" OR "ureteral stenting" OR "surgical treatment" were done. Systematic reviews and observational and clinical studies were analyzed to obtain indication regarding the objective of the study for a narrative review. Ninety-two papers were analyzed. The treatment of IRF includes the monitoring of retroperitoneal fibrotic process spread and the prevention of abdominal organs entrapment. Treatment of ureteral obstruction includes medical therapy and ureteral stenting (US) or percutaneous nephrostomy (PNS) to overcome the worsening of renal function. Up to now, the timing of US or PNS removal is not yet clear, both for the complexity of evaluating the efficacy of the medical therapy and demonstrating the resolution of obstructive nephropathy. Moreover, it is not yet clear if the long-term ureteral stent placement or PNS is able to maintain an efficient renal function. Ureterolysis with a laparoscopic robot-assisted approach is now considered as an ultimate treatment for ureteral obstruction, limiting the progression of kidney impairment and improving the quality of life of patients, although nephrologists are generally abdicant regarding the potential switch toward the surgical approach., Key Messages: Prospective studies regarding the long-term effects of US on the renal function impairment in patients with IRF should be structured to obtain adequate information on the exact timing for the surgical approach., (© 2022 S. Karger AG, Basel.)
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- 2023
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173. Validation of the Italian version of wisconsin stone quality of life (WISQOL): a prospective Italian multicenter study.
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Mazzon G, Serafin E, Ferretti S, Claps F, Zhong W, Fiori C, Celentano G, Guarino GG, Zamengo D, Piasentin A, Creta M, Longo N, Dordoni R, Pavan N, Brancelli C, Cerruto MA, Antonelli A, and Celia A
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- Humans, Quality of Life, Reproducibility of Results, Prospective Studies, Wisconsin, Language, Kidney Calculi surgery
- Abstract
Urolithiasis is a worldwide spread condition that affects patients' Health-Related Quality of Life (HRQOL), which measurement is an important tool for routine clinical and research practice. Disease-specific HRQOL measures demonstrated to perform better in assessing the effects of specific conditions. A disease-specific questionnaire for kidney stones, the WISQOL, has been validated in different languages, but an Italian version is still missing. Our aim is to produce and validate the Italian version of WISQOL (IT-WISQOL). Patients undergoing any elective treatment for upper urinary tract stones were enrolled. A multi-step process with forward- and back-translation was used to translate WISQOL into Italian. Patients were evaluated within 15 days pre-operatively and then at 30-, 90 days post-operatively and administered both IT-WISQOL and SF-36v2. Post-operative data such as 30 days postoperative complications, late stone-related events, successful status, and stone complexity were collected. Cronbach's α was used to evaluate the internal consistency of IT-WISQOL, while Spearman's rho was used for item and inter-domain correlations and IT-WISQOL with SF-36v2 correlation. We found excellent internal consistency across all domains (α ≥ 0.88), particularly when the total score is considered (α = 0.960). Test-retest reliability showed excellent results for the total questionnaire (Pearson correlation value: 0.85). The Inter-domain association ranged from 0.497 to 0.786. Convergent validity was confirmed by a good correlation with subdomains of the SF-36v2 measures. IT-WISQOL is a reliable tool to measure HRQOL in stone patients. It shows analog characteristics if compared to English WISQOL., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
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- 2022
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174. Free-indocyanine green-guided pelvic lymph node dissection during radical prostatectomy.
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Claps F, de Pablos-Rodríguez P, Gómez-Ferrer Á, Mascarós JM, Marenco J, Collado Serra A, Casanova Ramón-Borja J, Calatrava Fons A, Trombetta C, Rubio-Briones J, and Ramírez-Backhaus M
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- Male, Humans, Prospective Studies, Lymph Nodes surgery, Lymph Nodes pathology, Pelvis pathology, Prostatectomy methods, Lymph Node Excision methods, Lymphatic Metastasis pathology, Indocyanine Green, Prostatic Neoplasms surgery, Prostatic Neoplasms pathology
- Abstract
Introduction and Objectives: Extended Pelvic Lymph Node Dissection (ePLND) remains the most accurate technique for the detection of occult lymph node metastases (LNMs) in prostate cancer (CaP) patients. Here we aim to examine whether free-Indocyanine Green (F-ICG) could accurately assess the pathological nodal (pN) status in CaP patients during real-time lymphangiography as a potential replacement for ePLND., Materials and Methods: 219 consecutive patients undergoing F-ICG-guided PLND, ePLND and radical prostatectomy (RP) for clinical-localized CaPwere included in this prospective single-center study. The pathological outcomes of F-ICG-guided PLND were compared to confirmatory ePLND. Parameters of a binary diagnostic test for the proper classification of the pN status of patients ('per-patient' analysis) and for the probability of detecting all the metastatic LNs ('per-node' analysis) were calculated. Outcome measures were prevalence, accuracy (Acc), sensitivity (Se), negative predictive value (NPV), and likelihood ratio of a negative F-ICG-guided PLND test result [LR(-)]., Results: F-ICG-guided PLND successfully visualized LNs in all procedures with no adverse events. The overall per-patient F-ICG staging Acc was 97.7%, Se was 91.4%, with a NPV of 97.0%, and LR(-) of 8.6%. At the overall per-node level, 4,780 LNs were removed and 1,535 (32.1%) were fluorescent in vivo. F-ICG-guided PLND identified LNMs with a Se of 63.4%., Conclusions: This study confirms that F-ICG-guided lymphangiography correctly staged almost 98% of patients. The high per-patient NPV suggested that avoiding ePLND is safe for most patients when F-ICG stained nodes were pN0. Thus, more conservative approaches might minimise perioperative morbidity during LNMs diagnosis in selected patients., Competing Interests: Conflict of interest The authors declare that there are no conflict of interest., (Copyright © 2022 Elsevier Inc. All rights reserved.)
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- 2022
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175. Editorial Comment.
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Claps F and Trombetta C
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- 2022
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176. Developing a Diagnostic Multivariable Prediction Model for Urinary Tract Cancer in Patients Referred with Haematuria: Results from the IDENTIFY Collaborative Study.
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Khadhouri S, Gallagher KM, MacKenzie KR, Shah TT, Gao C, Moore S, Zimmermann EF, Edison E, Jefferies M, Nambiar A, Anbarasan T, Mannas MP, Lee T, Marra G, Gómez Rivas J, Marcq G, Assmus MA, Uçar T, Claps F, Boltri M, La Montagna G, Burnhope T, Nkwam N, Austin T, Boxall NE, Downey AP, Sukhu TA, Antón-Juanilla M, Rai S, Chin YF, Moore M, Drake T, Green JSA, Goulao B, MacLennan G, Nielsen M, McGrath JS, and Kasivisvanathan V
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- Humans, Male, Urologic Neoplasms complications, Urologic Neoplasms diagnosis, Urologic Neoplasms epidemiology, Urinary Bladder Neoplasms complications, Urinary Bladder Neoplasms diagnosis, Urinary Bladder Neoplasms epidemiology, Kidney Neoplasms
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Background: Patient factors associated with urinary tract cancer can be used to risk stratify patients referred with haematuria, prioritising those with a higher risk of cancer for prompt investigation., Objective: To develop a prediction model for urinary tract cancer in patients referred with haematuria., Design, Setting, and Participants: A prospective observational study was conducted in 10 282 patients from 110 hospitals across 26 countries, aged ≥16 yr and referred to secondary care with haematuria. Patients with a known or previous urological malignancy were excluded., Outcome Measurements and Statistical Analysis: The primary outcomes were the presence or absence of urinary tract cancer (bladder cancer, upper tract urothelial cancer [UTUC], and renal cancer). Mixed-effect multivariable logistic regression was performed with site and country as random effects and clinically important patient-level candidate predictors, chosen a priori, as fixed effects. Predictors were selected primarily using clinical reasoning, in addition to backward stepwise selection. Calibration and discrimination were calculated, and bootstrap validation was performed to calculate optimism., Results and Limitations: The unadjusted prevalence was 17.2% (n = 1763) for bladder cancer, 1.20% (n = 123) for UTUC, and 1.00% (n = 103) for renal cancer. The final model included predictors of increased risk (visible haematuria, age, smoking history, male sex, and family history) and reduced risk (previous haematuria investigations, urinary tract infection, dysuria/suprapubic pain, anticoagulation, catheter use, and previous pelvic radiotherapy). The area under the receiver operating characteristic curve of the final model was 0.86 (95% confidence interval 0.85-0.87). The model is limited to patients without previous urological malignancy., Conclusions: This cancer prediction model is the first to consider established and novel urinary tract cancer diagnostic markers. It can be used in secondary care for risk stratifying patients and aid the clinician's decision-making process in prioritising patients for investigation., Patient Summary: We have developed a tool that uses a person's characteristics to determine the risk of cancer if that person develops blood in the urine (haematuria). This can be used to help prioritise patients for further investigation., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)
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- 2022
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177. Assessing Trifecta Achievement after Percutaneous Cryoablation of Small Renal Masses: Results from a Multi-Institutional Collaboration.
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Piasentin A, Claps F, Silvestri T, Rebez G, Traunero F, Mir MC, Rizzo M, Celia A, Cicero C, Urbani M, Balestreri L, Pola L, Laganà F, Cernic S, Cova MA, Bertolotto M, Trombetta C, Liguori G, and Pavan N
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- Aged, Glomerular Filtration Rate, Humans, Nephrectomy methods, Retrospective Studies, Treatment Outcome, Cryosurgery adverse effects, Cryosurgery methods, Kidney Neoplasms surgery
- Abstract
Background and Objectives: To assess efficacy and safety of Percutaneous Cryoablation (PCA) of small renal masses (SRMs) using Trifecta outcomes in a large cohort of patients who were not eligible for surgery. Materials and methods: All PCAs performed in four different centers between September 2009 and September 2019 were retrospectively evaluated. Patients were divided in two different groups depending on masses dimensional criteria: Group-A: diameter ≤ 25 mm and Group-B: diameter > 25 mm. Complications rates were reported and classified according to the Clavien−Dindo system. The estimate glomerular filtration rate (eGFR) was calculated before PCA and during follow-up schedule. Every patient received a Contrast Enhanced Ultrasound (CEUS) evaluation on the first postoperative day. Radiological follow-up was taken at 3, 6, and 12 months for the first year, then yearly. Radiological recurrence was defined as a contrast enhancement persistence and was reported in the study. Finally, Trifecta outcome, which included complications, RFS, and preservation of eGFR class, was calculated for every procedure at a median follow-up of 32 months. Results: The median age of the patients was 74 years. Group-A included 200 procedures while Group-B included 140. Seventy-eight patients were eligible for Trifecta evaluation. Trifecta was achieved in 69.6% of procedures in Group-A, 40.6% in Group-B (p = 0.02). We observed an increased rate of complication in Group-B (13.0% vs. 28.6; p < 0.001). However, 97.5% were
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- 2022
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178. 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.
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Bartoletti R, Claps F, Tulone G, Perotti A, Zucchi A, Riccardi N, Ficarra V, De Nunzio C, Tubaro A, and Simonato A
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- Anti-Bacterial Agents pharmacology, Anti-Bacterial Agents therapeutic use, Antibiotic Prophylaxis methods, Biopsy methods, Fluoroquinolones therapeutic use, Humans, Male, Prostate pathology, Rectum microbiology, Bacterial Infections prevention & control, Diabetes Mellitus epidemiology
- Abstract
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., (© 2022. The Author(s).)
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- 2022
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179. Reliable Prediction of Post-Operative Complications' Rate Using the G8 Screening Tool: A Prospective Study on Elderly Patients Undergoing Surgery for Kidney Cancer.
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Traunero F, Claps F, Silvestri T, Mir MC, Ongaro L, Rizzo M, Piasentin A, Liguori G, Vedovo F, Celia A, Trombetta C, and Pavan N
- Abstract
In the last years the incidence of renal neoplasms has been steadily increasing, along with the average age of patients at the time of diagnosis. Surgical management for localized disease is becoming more challenging because of patients’ frailty. We conducted a multi-center prospective study to evaluate the role of the G8 as a screening tool in the assessment of intra and post-operative complications of elderly patients (≥70 y.o.) undergoing surgery for kidney cancer. A total of 162 patients were prospectively enrolled between January 2015 to January 2019 and divided into two study groups (frail vs. not-frail) according to their geriatric risk profile based on G8 score. Several factors (i.e., age, CCI, ASA score, preoperative anemia, RENAL score, surgical procedures, and techniques) were analyzed to identify whether any of them would configure as a statistically significant predictor of surgical complications. According to the G8 Score, 90 patients were included in the frail group. A total of 52 frail patients vs. 4 non-frail patients developed a postoperative complication of any kind (p < 0.001). Of these, 11 were major complications and all occurred in the frail group. Our results suggest that the G8 screening tool is an effective and useful instrument to predict the risk of overall complications in elderly patients prior to renal surgery.
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- 2022
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180. Warm ischemia time length during on-clamp partial nephrectomy: does it really matter?
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Abdel Raheem A, Alowidah I, Capitanio U, Montorsi F, Larcher A, Derweesh I, Ghali F, Mottrie A, Mazzone E, DE Naeyer G, Campi R, Sessa F, Carini M, Minervini A, Raman JD, Rjepaj CJ, Kriegmair MC, Autorino R, Veccia A, Mir MC, Claps F, Choi YD, Ham WS, Tadifa JP, Santok GD, Furlan M, Simeone C, Bada M, Celia A, Carrión DM, Aguilera Bazan A, Ballesteros Ruiz C, Malki M, Barber N, Hussain M, Micali S, Puliatti S, Alwahabi A, Alqahtani A, Rumaih A, Ghaith A, Ghoneem AM, Hagras A, Eissa A, Alenzi MJ, Pavan N, Traunero F, Antonelli A, Porcaro AB, Illiano E, Costantini E, and Rha KH
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- Cohort Studies, Glomerular Filtration Rate, Humans, Nephrectomy adverse effects, Retrospective Studies, Kidney Neoplasms pathology, Kidney Neoplasms surgery, Warm Ischemia adverse effects
- Abstract
Background: The impact of warm ischemia time (WIT) on renal functional recovery remains controversial. We examined the length of WIT>30 min on the long-term renal function following on-clamp partial nephrectomy (PN)., Methods: Data from 23 centers for patients undergoing on-clamp PN between 2000 and 2018 were analyzed. We included patients with two kidneys, single tumor, cT1, minimum 1-year follow-up, and preoperative eGFR≥60 mL/min/1.73m
2 . Patients were divided into two groups according to WIT length: group I "WIT≤30 min" and group II "WIT>30 min." A propensity-score matched analysis (1:1 match) was performed to eliminate potential confounding factors between groups. We compared eGFR values, eGFR (%) preservation, eGFR decline, events of chronic kidney disease (CKD) upgrading, and CKD-free progression rates between both groups. Cox regression analysis evaluated WIT impact on upgrading of CKD stages., Results: The primary cohort consisted of 3526 patients: group I (N.=2868) and group II (N.=658). After matching the final cohort consisted of 344 patients in each group. At last follow-up, there were no significant differences in median eGFR values at 1, 3, 5, and 10 years (P>0.05) between the matched groups. In addition, the median eGFR (%) preservation and absolute eGFR change were similar (89% in group I vs. 87% in group II, P=0.638) and (-10 in group I vs. -11 in group II, P=0.577), respectively. The 5 years new-onset CKD-free progression rates were comparable in the non-matched groups (79% in group I vs. 81% in group II, log-rank, P=0.763) and the matched groups (78.8% in group I vs. 76.3% in group II, log-rank, P=0.905). Univariable Cox regression analysis showed that WIT>30 min was not a predictor of overall CKD upgrading (HR:0.953, 95%CI 0.829-1.094, P=0.764) nor upgrading into CKD stage ≥III (HR:0.972, 95%CI 0.805-1.173, P=0.764). Retrospective design is a limitation of our study., Conclusions: Our analysis based on a large multicenter international cohort study suggests that WIT length during PN has no effect on the long-term renal function outcomes in patients having two kidneys and preoperative eGFR≥60 mL/min/1.73m2 .- Published
- 2022
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181. Comparison of Fluoroquinolones and Other Antibiotic Prophylaxis Regimens for Preventing Complications in Patients Undergoing Transrectal Prostate Biopsy.
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Tulone G, Giannone S, Mannone P, Tognarelli A, Di Vico T, Giaimo R, Zucchi A, Rossanese M, Abrate A, Pavan N, Claps F, Ficarra V, Bartoletti R, and Simonato A
- Abstract
Our study aimed to compare the incidence of infective complications after transrectal ultrasound-guided prostate biopsy (TRUSBx) when adopting different antimicrobial prophylaxis regimens. A multi-institutional cohort of 1150 patients who underwent TRUSBx was retrospectively analyzed. Procedures were performed between 2017 and 2019 (before and after the EMA warning about the use of fluoroquinolones for the antibiotic prophylaxis of patient candidates to TRUSBx). The primary endpoint was the occurrence of infective complications, including sepsis and/or fever. The population was stratified according to the antibiotic prophylaxis adopted: fluoroquinolones (levofloxacin, ciprofloxacin, prulifloxacin), cephalosporins (cefixime, ceftriaxone) or trimethoprim/sulfamethoxazole. Univariable and multivariable binomial logistic regression models were used to assess the odds ratio (OR) with 95% confidence interval (CI) testing of the risk of infective complication after adjusting for each prebiopsy covariate. In total, 478 (41.6%) patients received fluoroquinolone-based prophylaxis. Among these, 443 (38.5%), 25 (2.2%) and 10 (0.9%) patients received levofloxacin prophylaxis, ciprofloxacin and prulifloxacin, respectively while 14.6% received cefixime, 20.7% received the comedication of ceftriaxone/fosfomycin and 23.1% received trimethoprim/sulfamethoxazole. The trimethoprim/sulfamethoxazole and fluoroquinolone regimens were significantly associated with a lower risk of infective complications (OR 0.15, 95% CI 0.03−0.48, p = 0.003 and OR 0.17, 95% CI 0.06−0.43, p < 0.001, respectively). The ceftriaxone/fosfomycin (OR 0.21, 95% CI 0.04−0.92, p = 0.04) and fluoroquinolone (OR 0.07, 95% CI 0.00−0.70, p = 0.048) prophylaxis were associated with a lower risk of infective sequelae. Fluoroquinolone-based prophylaxis was associated with a lower risk of infective complications after TRUSBx compared to other prophylaxis regimens although its clinical application was recently forbidden by European Medical Agency restrictions.
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- 2022
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182. Echo-guided hydrodissection with local anesthetic to create a TICVAD pocket.
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Longo F, De Caris F, Piliego C, Claps F, Martuscelli M, and Agrò FE
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- Humans, Anesthesia, Local adverse effects, Anesthetics, Local adverse effects
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- 2022
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183. Optimization of the different therapeutic strategies in muscle invasive bladder cancer using biomarkers.
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Claps F, Mir C, and Rubio-Briones J
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- Biomarkers, Humans, Muscles, Neoplasm Invasiveness, Reproducibility of Results, Urinary Bladder Neoplasms surgery, Urinary Bladder Neoplasms therapy
- Abstract
Predicting response to definitive treatmentsis a fascinating challenge which develops throughthe evolution of a panel of convincing molecularbiomarkers capable of adding in clinical decissionsdespite interpatient and intratumoral heterogenicity.Muscle-invasive bladder cancer (MIBC) can be locallytreated either with radical cystectomy (RC) with or withoutneoadyuvant chemotherapy or bladder preservationapproaches such as trimodal therapy (TMT) includingmaximal transurethral resection of bladder tumor(TURBt) followed by external beam radiotherapy withconcurrent systemic radio-sensitizing chemotherapy.Conventional or novel/targeted systemic agents areessential parts of perioperative multidisciplinary managementconsidering both neoadjuvant and adjuvantsetting. Advances in molecular biology such as next generation sequencing and whole genome or transcriptomicanalysis, provided novel insights to achieve a fullunderstanding of the biology behind MIBC helping toidentify emerging predictive signatures. Although severalprogresses have been made, real-world applicationof molecular biomarkers in MIBC scenario is hinderedby lack of standardization, and low reproducibility. Inthis review we aim to present the emerging role of novelmolecular biomarkers in predicting response to localtreatments and systemic agents in MIBC.
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- 2022
184. Prognostic markers in invasive bladder cancer: FGFR3 mutation status versus P53 and KI-67 expression: a multi-center, multi-laboratory analysis in 1058 radical cystectomy patients.
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Mertens LS, Claps F, Mayr R, Bostrom PJ, Shariat SF, Zwarthoff EC, Boormans JL, Abas C, van Leenders GJLH, Götz S, Hippe K, Bertz S, Neuzillet Y, Sanders J, Broeks A, Peters D, van der Heijden MS, Jewett MAS, Stöhr R, Zlotta AR, Eckstein M, Soorojebally Y, van der Schoot DKE, Wullich B, Burger M, Otto W, Radvanyi F, Sirab N, Pouessel D, van der Kwast TH, Hartmann A, Lotan Y, Allory Y, Zuiverloon TCM, and van Rhijn BWG
- Subjects
- Cystectomy methods, Female, Humans, Ki-67 Antigen metabolism, Male, Mutation, Prognosis, Receptor, Fibroblast Growth Factor, Type 3 genetics, Retrospective Studies, Tumor Suppressor Protein p53 genetics, Tumor Suppressor Protein p53 metabolism, Urinary Bladder Neoplasms genetics, Urinary Bladder Neoplasms pathology, Urinary Bladder Neoplasms surgery
- Abstract
Objectives: To determine the association between the FGFR3 mutation status and immuno-histochemistry (IHC) markers (p53 and Ki-67) in invasive bladder cancer (BC), and to analyze their prognostic value in a multicenter, multi-laboratory radical cystectomy (RC) cohort., Patients and Methods: We included 1058 cN0M0, chemotherapy-naive BC patients who underwent RC with pelvic lymph-node dissection at 8 hospitals. The specimens were reviewed by uro-pathologists. Mutations in the FGFR3 gene were examined using PCR-SNaPshot; p53 and Ki-67 expression were determined by standard IHC. FGFR3 mutation status as well as p53 (cut-off>10%) and Ki-67 (cut-off>20%) expression were correlated to clinicopathological parameters and disease specific survival (DSS)., Results: pT-stage was
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- 2022
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185. Risk factors associated with positive surgical margins' location at radical cystectomy and their impact on bladder cancer survival.
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Claps F, van de Kamp MW, Mayr R, Bostrom PJ, Boormans JL, Eckstein M, Mertens LS, Boevé ER, Neuzillet Y, Burger M, Pouessel D, Trombetta C, Wullich B, van der Kwast TH, Hartmann A, Allory Y, Lotan Y, Shariat SF, Zuiverloon TCM, Mir MC, and van Rhijn BWG
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- Aged, Cohort Studies, Female, Humans, Male, Middle Aged, Risk Factors, Survival Rate, Urinary Bladder Neoplasms pathology, Cystectomy methods, Margins of Excision, Urinary Bladder Neoplasms mortality, Urinary Bladder Neoplasms surgery
- Abstract
Purpose: To evaluate the risk factors associated with positive surgical margins' (PSMs) location and their impact on disease-specific survival (DSS) in patients with bladder cancer (BCa) undergoing radical cystectomy (RC)., Methods: We analyzed a large multi-institutional cohort of patients treated with upfront RC for non-metastatic (cT1-4aN0M0) BCa. Multivariable binomial logistic regression analyses were used to assess the risk of PSMs at RC for each location after adjusting for clinicopathological covariates. The Kaplan-Meier method was used to estimate DSS stratified by margins' status and location. Log-rank statistics and Cox' regression models were used to determine significance., Results: A total of 1058 patients were included and 108 (10.2%) patients had PSMs. PSMs were located at soft-tissue, ureter(s), and urethra in 57 (5.4%), 30 (2.8%) and 21 (2.0%) patients, respectively. At multivariable analysis, soft-tissue PSMs were independently associated with pathological stage T4 (pT4) (Odds ratio (OR) 6.20, p < 0.001) and lymph-node metastases (OR 1.86, p = 0.04). Concomitant carcinoma-in-situ (CIS) was an independent risk factor for ureteric PSMs (OR 6.31, p = 0.003). Finally, urethral PSMs were independently correlated with pT4-stage (OR 5.10, p = 0.01). The estimated 3-years DSS rates were 58.2%, 32.4%, 50.1%, and 40.3% for negative SMs, soft-tissue-, ureteric- and urethral PSMs, respectively (log-rank; p < 0.001)., Conclusions: PSMs' location represents distinct risk factors' patterns. Concomitant CIS was associated with ureteric PSMs. Urethral and soft-tissue PSM showed worse DSS rates. Our results suggest that clinical decision-making paradigms on adjuvant treatment and surveillance might be adapted based on PSM and their location., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
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- 2021
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186. Prognostic value of preoperative albumin-to-fibrinogen ratio (AFR) in patients with bladder cancer treated with radical cystectomy.
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Claps F, Rai S, Mir MC, van Rhijn BWG, Mazzon G, Davis LE, Valadon CL, Silvestri T, Rizzo M, Ankem M, Liguori G, Celia A, Trombetta C, and Pavan N
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- Aged, Female, Humans, Male, Prognosis, Retrospective Studies, Albumins metabolism, Cystectomy methods, Fibrinogen metabolism, Urinary Bladder Neoplasms blood, Urinary Bladder Neoplasms surgery
- Abstract
Introduction and Objectives: To evaluate the prognostic role of albumin-to-fibrinogen ratio (AFR) for the prediction of oncological outcomes in a multi-institutional cohort of bladder cancer (BC) patients treated with radical cystectomy (RC)., Materials and Methods: We retrospectively analyzed a multicenter cohort of patients treated with upfront RC for localized (cT1-4aN0M0) BC. Multivariable logistic regression analyses were performed to evaluate the ability of AFR to predict non-organ confined (NOC) disease and lymph-node involvement (LNI) at time of RC. Multivariable Cox' regression models were performed to evaluate the prognostic effect of AFR on Time-to-Progression (TTP), overall survival (OS), and cancer-specific survival (CSS)., Results: A cut-off value to discriminate between low and high AFR was determined by calculating the receiver operating characteristic (ROC) curve. The area under the curve was 0.73 with an optimal cut-off at 9.53. Data were available for 246 patients (91 with low AFR, 155 with high AFR). Low AFR was associated with characteristics of tumor aggressiveness and independently predicted NOC (OR 2.11, P = 0.02) and LNI (OR 1.58, P = 0.04) at final pathological report. On multivariable Cox' regression analyses, preoperative low AFR was independently associated with worse TTP (HR 2.21, P = 0.02), OS (HR 2.24, P = 0.03), and CSS (HR 2.70, P = 0.01)., Conclusion: Preoperative low AFR is a prognostic biomarker for worse TTP, OS, CSS, and is independently associated with adverse tumor pathological features in BC patients undergoing RC. Our results suggest that especially patients with low AFR may be considered for neoadjuvant treatment., (Copyright © 2021 Elsevier Inc. All rights reserved.)
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- 2021
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187. Evaluation of Fluorescent Confocal Microscopy for Intraoperative Analysis of Prostate Biopsy Cores.
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Marenco J, Calatrava A, Casanova J, Claps F, Mascaros J, Wong A, Barrios M, Martin I, and Rubio J
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- Biopsy methods, Humans, Magnetic Resonance Imaging, Male, Microscopy, Confocal methods, Prostate diagnostic imaging, Prostate pathology, Prostate surgery, Prostatic Neoplasms diagnostic imaging, Prostatic Neoplasms surgery
- Abstract
Background: Diagnosis of prostate cancer is based on histopathological evaluation, which is time-consuming. Fluorescent confocal microscopy (FCM) is a novel technique that allows rapid tissue analysis., Objective: To determine if FCM could be used for real-time diagnosis of prostate cancer and evaluate concordance with traditional analysis., Design, Setting, and Participants: From January 2019 to March 2020, 182 magnetic resonance imaging-targeted prostate biopsy cores from 57 consecutive biopsy-naïve men with suspected prostate cancer were taken. These were intraoperatively stained with acridine orange for analysis using FCM (VivaScope; MAVIG, Munich, Germany) and subsequently sent for traditional haematoxylin-eosin histopathological (HEH) examination. Two expert uropathologists analysed the FCM and HEH cores blinded to the counterpart results in a single institution., Outcome Measurements and Statistical Analysis: Agreement between FCM and HEH analysis in terms of the presence of cancer was analysed at biopsy core and region of interest (ROI) levels, considering HEH as the reference test., Results and Limitations: FCM allowed intraoperative assessment of prostate biopsy cores with strong histopathological evaluation agreement: Cohen's κ for agreement was 0.81 at the biopsy core level and 0.69 for the ROI level. Positive predictive values (85% and 83.78%) and negative predictive values (95.1% and 85.71%) were high at the biopsy core and ROI levels. These initial results are encouraging, but given the single-centre and preliminary nature of the study, further confirmation is required., Conclusions: FCM allowed rapid evaluation of prostate biopsy cores. This technique is feasible and achieves rapid closure with a reliable diagnosis, parallel to the gold standard analysis. Initial results are promising but further studies are needed to validate and define the role of this technique., Patient Summary: A novel microscopic technique reduces the time needed to obtain a prostate cancer diagnosis by speeding up biopsy processing. Although the initial results are promising; this development needs to be confirmed in further studies., (Copyright © 2020. Published by Elsevier B.V.)
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- 2021
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188. The IDENTIFY study: the investigation and detection of urological neoplasia in patients referred with suspected urinary tract cancer - a multicentre observational study.
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Khadhouri S, Gallagher KM, MacKenzie KR, Shah TT, Gao C, Moore S, Zimmermann EF, Edison E, Jefferies M, Nambiar A, Mannas MP, Lee T, Marra G, Lillaz B, Gómez Rivas J, Olivier J, Assmus MA, Uçar T, Claps F, Boltri M, Burnhope T, Nkwam N, Tanasescu G, Boxall NE, Downey AP, Lal AA, Antón-Juanilla M, Clarke H, Lau DHW, Gillams K, Crockett M, Nielsen M, Takwoingi Y, Chuchu N, O'Rourke J, MacLennan G, McGrath JS, and Kasivisvanathan V
- Subjects
- Adult, Aged, Female, Hematuria etiology, Humans, Kidney Neoplasms complications, Male, Middle Aged, Prospective Studies, Referral and Consultation, Ureteral Neoplasms complications, Urinary Bladder Neoplasms complications, Kidney Neoplasms diagnosis, Ureteral Neoplasms diagnosis, Urinary Bladder Neoplasms diagnosis
- Abstract
Objective: To evaluate the contemporary prevalence of urinary tract cancer (bladder cancer, upper tract urothelial cancer [UTUC] and renal cancer) in patients referred to secondary care with haematuria, adjusted for established patient risk markers and geographical variation., Patients and Methods: This was an international multicentre prospective observational study. We included patients aged ≥16 years, referred to secondary care with suspected urinary tract cancer. Patients with a known or previous urological malignancy were excluded. We estimated the prevalence of bladder cancer, UTUC, renal cancer and prostate cancer; stratified by age, type of haematuria, sex, and smoking. We used a multivariable mixed-effects logistic regression to adjust cancer prevalence for age, type of haematuria, sex, smoking, hospitals, and countries., Results: Of the 11 059 patients assessed for eligibility, 10 896 were included from 110 hospitals across 26 countries. The overall adjusted cancer prevalence (n = 2257) was 28.2% (95% confidence interval [CI] 22.3-34.1), bladder cancer (n = 1951) 24.7% (95% CI 19.1-30.2), UTUC (n = 128) 1.14% (95% CI 0.77-1.52), renal cancer (n = 107) 1.05% (95% CI 0.80-1.29), and prostate cancer (n = 124) 1.75% (95% CI 1.32-2.18). The odds ratios for patient risk markers in the model for all cancers were: age 1.04 (95% CI 1.03-1.05; P < 0.001), visible haematuria 3.47 (95% CI 2.90-4.15; P < 0.001), male sex 1.30 (95% CI 1.14-1.50; P < 0.001), and smoking 2.70 (95% CI 2.30-3.18; P < 0.001)., Conclusions: A better understanding of cancer prevalence across an international population is required to inform clinical guidelines. We are the first to report urinary tract cancer prevalence across an international population in patients referred to secondary care, adjusted for patient risk markers and geographical variation. Bladder cancer was the most prevalent disease. Visible haematuria was the strongest predictor for urinary tract cancer., (© 2021 The Authors BJU International published by John Wiley & Sons Ltd on behalf of BJU International.)
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- 2021
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189. Molecular markers of systemic therapy response in urothelial carcinoma.
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Claps F, Mir MC, and Zargar H
- Abstract
Identification of reliable molecular biomarkers that can complement clinical practice represents a fascinating challenge in any cancer field. Urothelial carcinoma is a very heterogeneous disease and responses to systemic therapies, and outcomes after radical cystectomy are difficult to predict. Advances in molecular biology such as next generation sequencing and whole genome or transcriptomic analysis provide promising platforms to achieve a full understanding of the biology behind the disease and can identify emerging predictive biomarkers. Moreover, the ability to categorize patients' risk of recurrence after curative treatment, or even predict benefit from a conventional or targeted therapies, represents a compelling challenge that may reshape both selection for tailored treatment and disease monitoring. Progress has been made but currently no molecular biomarkers are used in the clinical setting to predict response to systemic agents in either neoadjuvant or adjuvant settings highlighting a relevant unmet need. Here, we aim to present the emerging role of molecular biomarkers in predicting response to systemic agents in urothelial carcinoma., Competing Interests: The authors declare no conflict of interest., (© 2021 Editorial Office of Asian Journal of Urology. Production and hosting by Elsevier B.V.)
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- 2021
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190. Corrigendum to 'Development of a Novel Risk Score to Select the Optimal Candidate for Cytoreductive Nephrectomy Among Patients with Metastatic Renal Cell Carcinoma. Results from a Multi-institutional Registry (REMARCC)' [European Urology Oncology 3 (2021) 256-263].
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Marchioni M, Kriegmair M, Heck M, Amiel T, Porpiglia F, Checcucci E, Campi R, Minervini A, Mari A, Van Bruwaene S, Linares E, Hevia V, Musquera M, D'Anna M, Derweesh I, Bradshaw A, Autorino R, Guruli G, Veccia A, Roussel E, Albersen M, Pavan N, Claps F, Antonelli A, Palumbo C, Klatte T, Erdem S, and Carmen Mir M
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- 2021
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191. Incidence, predictive factors and survival outcomes of incidental prostate cancer in patients who underwent radical cystectomy for bladder cancer.
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Claps F, Pavan N, Umari P, Rizzo M, Barbone F, Giangreco M, Liguori G, Mir CM, Bussani R, and Trombetta C
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- Adult, Aged, Aged, 80 and over, Follow-Up Studies, Humans, Incidence, Male, Middle Aged, Neoplasms, Multiple Primary epidemiology, Neoplasms, Multiple Primary etiology, Neoplasms, Multiple Primary therapy, Prognosis, Prostatic Neoplasms epidemiology, Prostatic Neoplasms etiology, Prostatic Neoplasms therapy, Retrospective Studies, Risk Factors, Survival Analysis, Urinary Bladder Neoplasms mortality, Cystectomy, Neoplasms, Multiple Primary diagnosis, Prostatic Neoplasms diagnosis, Urinary Bladder Neoplasms surgery
- Abstract
Background: The aim of this study was to analyze the incidence, preoperative findings, pathological features and prognosis in patients with incidental prostate cancer (iPCa) detected at radical cystectomy (RC) for bladder cancer (BCa)., Methods: We retrospectively reviewed data of patients who underwent RC for BCa at our Institution between January 2005 and March 2018. Data regarding patient's history, preoperative digital rectal examination (DRE), total serum PSA level were collected from the chart review. Univariable and multivariable Cox regression models addressed the association of iPCa with recurrence-free survival (RFS) and overall survival (OS)., Results: We obtained a final study cohort of 177 patients. Median age was 69 years (IQR 42-89) and 80(45.2%) patients had iPCa. Patients with iPCa had higher age, preoperative PSA levels and a significant rate of suspicious DRE (all P<0.05). Four patients had BCR during a median follow-up of 28 months (IQR 6-159) and none died for prostate cancer. In multivariable analyses adjusted for age, bladder cancer BCa pT and pN stage and LVI the ten-years RFS and OS rates were not impacted by iPCa regardless of whether it is a clinically significant cancer or not (HR=1.25, 95% CI: 0.65-2.38, P=0.51 vs. HR=1.37, 95% CI: 0.71-2.64, P=0.35) (HR=1.04, 95% CI: 0.53-1.86, P=0.89 vs. HR=1.20, 95% CI: 0.22-6.72, P=0.83)., Conclusions: iPCa is quite common in our study group and most of cases are organ-confined and well differentiated. Regardless of clinical relevance, iPCa does not have an impact on survival outcomes as BCa is driving the prognosis of these patients.
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- 2021
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192. Rebiopsy rate after transperineal or transrectal prostate biopsy.
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Marenco Jimenez JL, Claps F, Ramón-Borja JC, Mascarós Martinez JM, Gutierrez AW, Lozano ÁGF, Ramírez-Backhaus M, Domìnguez Escrig JL, Serra AC, and Rubio-Briones J
- Abstract
Background: In recent years, transperineal biopsies gained popularity for prostate cancer diagnosis; lower infective complications and improved sampling of the prostate are the main advantages of this technique. One question that remains unclear is whether an initial transperineal biopsy confers a lower risk for rebiopsy compared with the transrectal approach., Methods: Six hundred seventy-one men were prospectively followed after an initial negative prostate biopsy for a median period of 49.50 (IQR: 37.62-61.17) months. Rebiopsy rate was analyzed attending to first biopsy approach (transrectal versus transperineal systematic) and clinical variables., Results: Diagnostic rate was similar for transrectal and transperineal systematic biopsies. Targeted biopsies outperformed any systematic approach, and transperineal targeted in particular was superior to transrectal targeted. Rebiopsy rates were 15.4% and 5.26% for the transrectal and transperineal systematic groups, respectively. Prostate-specific antigen density and type of first biopsy were identified as rebiopsy predictors., Conclusion: Men undergoing transperineal systematic biopsies had a three times lower rate of rebiopsy over the study period compared with the traditional transrectal approach. This advantage could be added to the already described potential benefits of transperineal biopsies. Targeted biopsies had lower rebiopsy rate over the study period. Further innovations that decreased the cost of transperineal biopsies could favor this approach in the future., Competing Interests: All authors have no conflict of interest to declare., (© 2020 Asian Pacific Prostate Society. Published by Elsevier B.V.)
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- 2021
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193. Indocyanine green guidance improves the efficiency of extended pelvic lymph node dissection during laparoscopic radical prostatectomy.
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Claps F, Ramírez-Backhaus M, Mir Maresma MC, Gómez-Ferrer Á, Mascarós JM, Marenco J, Collado Serra A, Casanova Ramón-Borja J, Calatrava Fons A, Trombetta C, and Rubio-Briones J
- Subjects
- Humans, Indocyanine Green, Lymph Node Excision, Lymph Nodes surgery, Male, Pelvis surgery, Prostatectomy, Laparoscopy, Prostatic Neoplasms surgery
- Abstract
Objectives: To evaluate whether indocyanine green guidance can improve the quality of extended pelvic lymph node dissection in patients undergoing radical prostatectomy., Methods: A total of 214 patients underwent laparoscopic radical prostatectomy with indocyanine green-guided lymph node dissection plus extended pelvic lymph node dissection. These patients (group A) were matched 1:1 for clinical risk groups according to the National Comprehensive Cancer Network classification with patients who underwent the same procedure without fluorescence guidance (group B). Biochemical recurrence was defined as two consecutive prostate-specific antigen rises of at least 0.2 ng/mL. The Kaplan-Meier method and Cox regression models were used to identify predictors of biochemical recurrence., Results: The median number of retrieved nodes was significantly higher in group A (22 vs 14, P < 0.001). The rate of lymph node metastases was higher in group A (65.9% vs 34.1%, P = 0.01). Increasing the yield of lymph node dissection was independently and negatively correlated with the biochemical recurrence risk in both overall and pN-positive patients (hazard ratio 0.97, P = 0.03; and hazard ratio 0.95, P = 0.02). The 5-year biochemical recurrence-free survival rates were (75.8% vs 65.9, P = 0.09) and (54.1% vs 24.9%, P = 0.023) for group A and group B in the overall cohort and pN-positive cohort, respectively., Conclusion: Indocyanine green-guided lymph node dissection plus extended pelvic lymph node dissection improves identification of lymphatic drainage, resulting in a higher number of lymph nodes and retrieved lymph node metastases, and allowing a more accurate local staging and a prolonged biochemical recurrence-free survival., (© 2021 The Japanese Urological Association.)
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- 2021
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194. Development of a Novel Risk Score to Select the Optimal Candidate for Cytoreductive Nephrectomy Among Patients with Metastatic Renal Cell Carcinoma. Results from a Multi-institutional Registry (REMARCC).
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Marchioni M, Kriegmair M, Heck M, Amiel T, Porpiglia F, Ceccucci E, Campi R, Minervini A, Mari A, Van Bruwaene S, Linares E, Hevia V, Musquera M, D'Anna M, Derweesh I, Bradshaw A, Autorino R, Guruli G, Veccia A, Roussel E, Albersen M, Pavan N, Claps F, Antonelli A, Palumbo C, Klatte T, Erdem S, and Mir MC
- Subjects
- Cytoreduction Surgical Procedures, Humans, Nephrectomy, Registries, Retrospective Studies, Risk Factors, Carcinoma, Renal Cell surgery, Kidney Neoplasms drug therapy, Kidney Neoplasms surgery
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Background: Selection of patients for upfront cytoreductive nephrectomy (CN) in metastatic renal cell carcinoma (mRCC) has to be improved., Objective: To evaluate a new scoring system for the prediction of overall mortality (OM) in mRCC patients undergoing CN., Design, Setting, and Participants: We identified a total of 519 patients with synchronous mRCC undergoing CN between 2005 and 2019 from a multi-institutional registry (Registry for Metastatic RCC [REMARCC])., Outcome Measurements and Statistical Analysis: Cox proportional hazard regression was used to test the main predictors of OM. Restricted mean survival time was estimated as a measure of the average overall survival time up to 36 mo of follow-up. The concordance index (C-index) was used to determine the model's discrimination. Decision curve analyses were used to compare the net benefit from the REMARCC model with International mRCC Database Consortium (IMDC) or Memorial Sloan Kettering Cancer Center (MSKCC) risk scores., Results and Limitations: The median follow-up period was 18 mo (interquartile range: 5.9-39.7). Our models showed lower mortality rates in obese patients (p = 0.007). Higher OM rates were recorded in those with bone (p = 0.010), liver (p = 0.002), and lung metastases (p < 0.001). Those with poor performance status (<80%) and those with more than three metastases had also higher OM rates (p = 0.026 and 0.040, respectively). The C-index of the REMARCC model was higher than that of the MSKCC and IMDC models (66.4% vs 60.4% vs 60.3%). After stratification, 113 (22.0%) patients were classified to have a favorable (no risk factors), 202 (39.5%) an intermediate (one or two risk factors), and 197 (38.5%) a poor (more than two risk factors) prognosis. Moreover, 72 (17.2%) and 51 (13.9%) patients classified as having an intermediate and a poor prognosis according to MSKCC and IMDC categories, respectively, would be reclassified as having a good prognosis according to the REMARCC score., Conclusions: Our findings confirm the relevance of tumor and patient features for the risk stratification of mRCC patients and clinical decision-making regarding CN. Further prospective external validations are required for the scoring system proposed herein., Patient Summary: Current stratification systems for selecting patients for kidney removal when metastatic disease is shown are controversial. We suggest a system that includes tumor and patient features besides the systems already in use, which are based on blood tests., (Copyright © 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved.)
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- 2021
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195. Analysis of clinical utility of abdominopelvic computed tomography in the follow-up of Stage I seminoma: a single center evaluation.
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Rizzo M, Ongaro L, Claps F, Ghassempour D, Verzotti E, Migliozzi F, Boltri M, Pavan N, Garaffa G, Bucci S, Umari P, Trombetta C, and Liguori G
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- Adult, Humans, Male, Middle Aged, Aorta diagnostic imaging, Follow-Up Studies, Neoplasm Recurrence, Local, Orchiectomy, Retrospective Studies, Scrotum diagnostic imaging, Abdomen diagnostic imaging, Pelvis diagnostic imaging, Seminoma diagnostic imaging, Seminoma surgery, Testicular Neoplasms diagnostic imaging, Testicular Neoplasms surgery, Tomography, X-Ray Computed adverse effects, Tomography, X-Ray Computed methods
- Abstract
Background: Abdominopelvic computed tomography (CT) is widely used in the follow-up of seminoma patients after radical orchidectomy. The aim of this study was to evaluate the clinical utility of abdominopelvic computed tomography in the follow-up of patients with Stage I seminoma., Methods: The pathological reports of all patients that have undergone radical orchidectomy in our tertiary referral center between January 2002 and January 2018 have been retrospectively reviewed. All patients with Stage I seminoma and negative serum tumor markers after radical orchidectomy were included. Patients with follow-up shorter than 12 months were excluded. Surveillance records of every patient were reviewed with regard to abdominopelvic imaging., Results: Of the 133 patients who have undergone radical orchidectomy in our center, 55 had Stage I pure seminoma with normal levels of serum tumor markers after surgery. Two patients were excluded as the follow-up was inadequate. Mean follow-up was 63.2 months (IQR: 30-73). The results of 211 abdominopelvic CTs performed as part of the follow-up were reviewed. Two (3,7%) patients developed recurrence; one consisted of a scrotal lump and was diagnosed with ultrasonography (US) while the second appeared as paraaortic nodal metastasis and was diagnosed with abdominopelvic CT. The recurrence was successfully treated in both patients. A single abdominopelvic CT was useful for the detection of recurrent disease in our entire study population. No cancer specific death has been reported in the study population., Conclusions: Follow-up schedules for Stage I seminoma expose patients to potential risks of radiation-induced tumors, emotional distress and represent a significant burden for the healthcare system. The current series suggests that a better risk adapted patient-tailored follow-up program is needed in order to avoid unnecessary investigations.
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- 2021
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196. An Observational Cohort Study Investigating the Incidence Rate of Infectious Complications After Routine Office Nephrostomy Tube Replacement Without Using Antimicrobial Prophylaxis.
- Author
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Rizzo M, Ongaro L, Claps F, Cai T, Umari P, Bucci S, Trombetta C, and Liguori G
- Subjects
- Aged, Aged, 80 and over, Anti-Bacterial Agents pharmacology, Cohort Studies, Female, Fever, Humans, Incidence, Male, Patient Admission, Prospective Studies, Regression Analysis, Risk, Surveys and Questionnaires, Anti-Infective Agents pharmacology, Antibiotic Prophylaxis methods, Nephrostomy, Percutaneous adverse effects, Nephrostomy, Percutaneous instrumentation
- Abstract
Objective: To investigate the incidence of infectious complications after routine office nephrostomy tube replacement (NTR) in patients that did not receive antimicrobial prophylaxis (AMP)., Methods: We prospectively enrolled all patients undergoing routine office NTR between July 2018 and September 2019. Each procedure was considered an independent event. Clinical, microbiological, demographic data were collected. AMP was exclusion criterion. All patients received a questionnaire via phone call within 3 weeks after NTR investigating fever, antibiotics use, hospital admissions. Infectious complications risk was assessed with univariate and multivariate binomial logistic regression analysis., Results: One hundred forty-five routine NTRs were performed. Nineteen patients receiving AMP were excluded. Median age was 78 years (interquartile range 71-81). Charlson Comorbidity Index (CCI) score was ≥5 in 53.2% of patients, 34 had positive urine culture, none received AMP. Seventeen (13.49%) patients reported fever after procedure, 9 received antibiotic therapy while fever resolved spontaneously in 8. Three patients needed hospitalization, 2 for nephrostomy malfunction, 1 for infectious complications. At multivariate analysis only CCI score ≥3 was associated (P < .001) with increased infectious complications risk., Conclusion: In this study fever occurs after the 13.5% of the routine NTRs, in almost half cases resolves spontaneously rather than with oral antimicrobial therapy. Avoiding AMP before routine NTR does not expose patients to life-threatening infections., (Copyright © 2020 Elsevier Inc. All rights reserved.)
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- 2021
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197. Smart learning for urology residents during the COVID-19 pandemic and beyond: insights from a nationwide survey in Italy.
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Claps F, Amparore D, Esperto F, Cacciamani G, Fiori C, Minervini A, Liguori G, Trombetta C, Porpiglia F, Serni S, Checcucci E, and Campi R
- Subjects
- Humans, Internet, Italy, Surveys and Questionnaires, COVID-19, Education, Distance, Internship and Residency organization & administration, Pandemics, Urology education
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- 2020
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198. Impact of the COVID-19 pandemic on urology residency training in Italy.
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Amparore D, Claps F, Cacciamani GE, Esperto F, Fiori C, Liguori G, Serni S, Trombetta C, Carini M, Porpiglia F, Checcucci E, and Campi R
- Subjects
- COVID-19, Education, Distance, General Surgery education, General Surgery statistics & numerical data, Humans, Internship and Residency statistics & numerical data, Italy, Surveys and Questionnaires, Telemedicine, Urologic Surgical Procedures, Coronavirus Infections, Internship and Residency trends, Pandemics, Pneumonia, Viral, Urology education
- Abstract
In the global emergency scenario caused by COVID-19 pandemic, the Urology residents' training might be critically affected. To provide insights on this issue, a 25-item online Survey was sent to all Italian residents one month after the first case of COVID-19 in Italy, to evaluate their routine involvement in "clinical" (on-call duty, outpatient visits, diagnostic procedures) and "surgical" (endoscopic, open and minimally invasive surgery) training activities before and during the COVID-19 period. Overall, 351 of 577 (60.8%) residents completed the Survey. Before the COVID-19 pandemic, the proportion of residents routinely involved in "clinical" and "surgical" activities ranged from 79.8% to 87.2% and from 49.3% to 73.5%, respectively. In the COVID-19 period, the proportion of residents experiencing a severe reduction (>40%) or complete suppression (>80%) of training exposure ranged between 41.1% and 81.2% for "clinical" activities while between 44.2% and 62.1% for "surgical" activities. This reduction was even more pronounced for residents attending the final year of training. Our study is the first to provide real-life data on how Urology residency training can be impaired during an emergency period. To address this challenge, strategies aiming to increase the use of telemedicine, "smart learning" programs and tele-mentoring of surgical procedures, are warranted.
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- 2020
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199. Rates and Predictors of Perioperative Complications in Cytoreductive Nephrectomy: Analysis of the Registry for Metastatic Renal Cell Carcinoma.
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Roussel E, Campi R, Larcher A, Verbiest A, Antonelli A, Palumbo C, Derweesh I, Ghali F, Bradshaw A, Meagher MF, Heck M, Amiel T, Kriegmair MC, Rubio J, Musquera M, D'Anna M, Autorino R, Guruli G, Veccia A, Linares-Espinos E, Van Bruwaene S, Hevia V, Porpiglia F, Checcucci E, Minervini A, Mari A, Pavan N, Claps F, Marchioni M, Capitanio U, Beuselinck B, Mir MC, and Albersen M
- Subjects
- Aged, Carcinoma, Renal Cell secondary, Female, Humans, Kidney Neoplasms pathology, Male, Middle Aged, Prognosis, Registries, Retrospective Studies, Carcinoma, Renal Cell surgery, Cytoreduction Surgical Procedures, Kidney Neoplasms surgery, Nephrectomy methods, Postoperative Complications epidemiology
- Abstract
Background: Cytoreductive nephrectomy (CN) plays an important role in the treatment of a subgroup of metastatic renal cell carcinoma (mRCC) patients., Objective: We aimed to evaluate morbidity associated with this procedure and identify potential predictors thereof to aid patient selection for this procedure and potentially improve patient outcomes., Design, Setting, and Participants: Data from 736 mRCC patients undergoing CN at 14 institutions were retrospectively recorded in the Registry for Metastatic RCC (REMARCC)., Outcome Measurements and Statistical Analysis: Logistic regression analysis was used to identify predictors for intraoperative, any-grade (AGCs), low-grade, and high-grade (HGCs) postoperative complications (according to the Clavien-Dindo classification) as well as 30-d readmission rates., Results and Limitations: Intraoperative complications were observed in 69 patients (10.9%). Thrombectomy (odds ratio [OR] 1.38, 95% confidence interval [CI] 1.08-1.75, p = 0.009) and adjacent organ removal (OR 2.7, 95% CI 1.38-5.30) were significant predictors of intraoperative complications at multivariable analysis. Two hundred seventeen patients (29.5%) encountered AGCs, while 45 (6.1%) encountered an HGC, of whom 10 (1.4%) died. Twenty-four (3.3%) patients had multiple postoperative complications. Estimated blood loss (EBL; OR 1.49, 95% CI 1.08-2.05, p = 0.01) was a significant predictor of AGCs at multivariable analysis. CN case load (OR 0.13, 95% CI 0.03-0.59, p = 0.009) and EBL (OR 2.93, 95% CI 1.20-7.15, p = 0.02) were significant predictors solely for HGCs at multivariable analysis. Forty-one patients (11.5%) were readmitted within 30 d of surgery. No significant predictors were identified. Results were confirmed in a subanalysis focusing solely on patients treated in the contemporary targeted therapy era., Conclusions: Morbidity associated with CN is not negligible. Predictors of high-grade postoperative morbidity are predominantly indicators of complex surgery. EBL is a strong predictor of postoperative complications. CN case load correlates with lower high-grade morbidity and highlights the benefit of centralization of complex surgery. However, risks and benefits should be balanced when considering CN in mRCC patients., Patient Summary: We studied patients with metastatic renal cancer to evaluate the outcomes associated with the surgical removal of the primary kidney tumor. We found that this procedure is often complex and adverse events are not uncommon. High intraoperative blood loss and a small number of cases performed at the treating center are associated with a higher rate of postoperative complications., (Copyright © 2020. Published by Elsevier B.V.)
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- 2020
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200. Slowdown of urology residents' learning curve during the COVID-19 emergency.
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Porpiglia F, Checcucci E, Amparore D, Verri P, Campi R, Claps F, Esperto F, Fiori C, Carrieri G, Ficarra V, Mario Scarpa R, and Dasgupta P
- Subjects
- Betacoronavirus, COVID-19, Humans, SARS-CoV-2, Teaching, Coronavirus Infections epidemiology, Internship and Residency, Learning Curve, Pandemics, Pneumonia, Viral epidemiology, Urologic Surgical Procedures education
- Published
- 2020
- Full Text
- View/download PDF
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