The challenging management of malignant ureteral obstruction: Analysis of a series of 188 cases.

Background: Malignant ureteral obstruction (MUO) is a common condition that complicates the course of advanced malignancies. The aims of this study are to analyze the causes, management, and survival of patients with obstructive nephropathy due to malignant ureteric obstruction and to determine prognostic factors. Furthermore, we studied the complications and outcomes in patients who underwent urinary diversion. Materials and methods: A retrospective study was conducted on patients with computed tomography-confirmed MUO between January 2016 and November 2020. Demographic, clinical, radiological, laboratory, and management data were collected. Survival curves were estimated using the Kaplan-Meier method, and univariate and multivariate Cox proportional hazards models were used to test the association between parameters and survival. Results: A total of 188 patients were included. The mean age was 69.01 years (SD, 14.95 years), and the majority (54.8%) were male. The most common mechanism leading to MUO was compression by a pelvic mass (36.9%), and the 3 most frequent tumors causing MUO were prostate (17.6%), bladder (16.5%), and rectal cancer (11.7%).Forty-seven patients (25%) underwent urinary diversion: 23 (48.9%) underwent double-J stenting and 21 (44.7%) underwent percutaneous nephrostomy. The most common reason for urinary diversion was acute kidney injury (53.3%). Recovery of renal function was observed in 55.8% of the patients after urinary diversion. The most frequently identified complications after urinary diversion were urinary tract infection (24.4%), hematuria (17.0%), and urinary sepsis (14.9%). The median survival after hydronephrosis diagnosis was 6.43 months (interquartile range, 1.91-14.81 months). In patients who underwent urinary decompression, the median survival after urinary diversion was 8.67 months (interquartile range, 2.99-17.28 months). In the multivariate analysis, a lower grade of hydronephrosis and cancer cachexia negatively impacted survival. Conclusions: Cancer patients with MUO have a poor prognosis; therefore, the risk-benefit ratio of urinary diversion should be carefully considered. Cachexia and hydronephrosis grade can be useful in selecting suitable candidates for urinary diversion.

Surgery for adrenal metastasis: Surgical outcomes and prognostic factors for long-term survival.

PURPOSE: To analyze surgical outcomes and predictive factors for long-term overall and disease-specific survival in patients undergoing surgical resection of adrenal metastasis. METHODS: A multicenter retrospective study included patients who underwent adrenalectomy for adrenal metastasis in two Spanish hospitals between 2005 and 2021. Clinical variables associated with surgical complications and survival during follow-up were analyzed. RESULTS: Thirty-three patients were included. Adrenalectomy was performed laparoscopically in 27 patients and by an open approach in 6. The most common primary tumor site was the lung (n=15), followed by the kidney (n=7). Most patients had metachronous lesions (n=28). Six patients (18.2%) had intra- and/or postoperative complications; synchronous metastasis was a risk factor (odds ratio 12.5 [1.45-107.6]) for their development. Progression-free survival and disease-specific survival were 7.5months (range 1-64) and 22.5months (6-120), respectively. Survival rates at 1, 2, 3 and 5years were 94%, 65%, 48% and 29%, respectively. Survival was significantly lower in patients with lung cancer than with other cancers (hazard ratio 4.23 [1.42-12.59]). CONCLUSIONS: Adrenalectomy for solitary adrenal metastases was associated with intra- or postoperative complications in 18% of cases. Synchronous metastasis was a risk factor for complications.

Unlocking the Potential of Adequate Bacillus Calmette-Guérin Immunotherapy in Very-high-risk Non-muscle-invasive Bladder Carcinoma: A Multicenter Analysis of Oncological Outcomes and Risk Dynamics.

BACKGROUND: The European Association of Urology (EAU) recommends discussing upfront radical cystectomy for all patients with very high risk (VHR) non-muscle-invasive bladder carcinoma (NMIBC), but the role of bacillus Calmette-Guérin (BCG) treatment remains controversial. OBJECTIVE: To analyze oncological outcomes in VHR NMIBC patients (EAU risk groups) treated with adequate BCG. DESIGN, SETTING, AND PARTICIPANTS: A multi-institutional retrospective study involving patients with VHR NMIBC who received adequate BCG therapy from 2007 to 2020 was conducted. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: A survival analysis estimated recurrence-free survival (RFS), progression-free survival (PFS), and the cumulative incidence of cancer-specific mortality (CSM) after accounting for other causes of mortality as competing risk events and of the overall mortality (OM). Conditional survival probabilities for 0-4 yr without events were computed. Cox regression assessed the predictors of oncological outcomes. RESULTS AND LIMITATION: A total of 640 patients, with a median 47 (32-67) mo follow-up for event-free individuals, were analyzed. High-grade RFS and PFS at 5 yr were 53% (49-57%) and 78% (74-82%), respectively. The cumulative incidence of CSM and OM at 5 yr was 13% (10-16%) and 16% (13-19%), respectively. Conditional RFS, PFS, overall survival, and cancer-specific survival at 4 yr were 91%, 96%, 87%, and 94%, respectively. Cox regression identified tumor grade (hazard ratio [HR]: 1.54; 1.1-2) and size (HR: 1.3; 1.1-1.7) as RFS predictors. Tumor multiplicity predicted RFS (HR: 1.6; 1.3-2), PFS (HR: 2; 1.2-3.3), and CSM (HR: 2; 1.2-3.2), while age predicted OM (HR: 1.48; 1.1-2). CONCLUSIONS: Patients with VHR NMIBC who receive adequate BCG therapy have a more favorable prognosis than predicted by EAU risk groups, especially among those with a sustained response, in whom continuing maintenance therapy emerges as a viable alternative to radical cystectomy. PATIENT SUMMARY: Our research shows that a sustained response to bacillus Calmette-Guérin in patients can lead to favorable outcomes, serving as a viable alternative to cystectomy for select cases.

Influence of obesity and overweight in surgical outcomes of adrenalectomy for primary adrenal disease: A cohort study of 146 cases.

OBJECTIVE: To evaluate the impact of obesity and overweight on surgical outcomes in a large cohort of patients who underwent adrenalectomy due to benign or malignant primary adrenal disease. METHODS: A retrospective single-center study of patients without history of active extraadrenal malignancy, with adrenal tumors operated on consecutively in our center between January 2010 and December 2022. Obesity was defined as a body mass index (BMI)≥30kg/m2 and overweight as BMI between 25.0 and 30.0kg/m2. RESULTS: Of 146 patients with adrenal tumors who underwent adrenalectomy, 9.6% (n=14) were obese, 54.8% (n=80) overweight and 35.6% (n=52) normal weight. Obese patients had higher diastolic blood pressure (87.6±12.22 vs. 79.3±10.23mmHg, P=0.010) and a higher prevalence of dyslipidemia (57.1% vs. 25.8%, P=0.014) and bilateral tumors (14.3% vs. 3.1%, P=0.044) than non-obese patients. The rates of intraoperative and of postsurgical complications were similar between obese/overweight patients and patients with normal weight. However, a significantly higher rate of postsurgical complications (27.3% vs. 5.7%, P=0.009) and a longer hospital stay (5.4±1.39 vs. 3.5±1.78 days, P=0.007) were observed in patients with obesity than in non-obese patients. In the multivariant analysis, obesity, age, ASA>2 and tumor size were independent risk factors for postoperative complications, with obesity being the most important factor (OR 23.34 [2.23-244.24]). CONCLUSION: Obesity and overweight are common conditions in patients who undergo adrenalectomy. Adrenalectomy is considered a safe procedure in patients with overweight, but it is associated with a higher risk of postsurgical complications and longer hospital stay in obese patients.

Primary testicular lymphoma: Clinical characteristics and oncological outcomes.

Background: Primary testicular lymphoma (PTL) is a rare testicular malignancy, despite being considered the most common testicular tumor in patients older than 60 years. Primary testicular lymphoma represents only 1%-9% of testicular neoplasms. Few studies have been published regarding its clinical features and management. This study aimed to analyze the clinical characteristics and outcomes of PTL. Materials and methods: Orchiectomy specimens of 15 patients with PTL diagnosed during 2000-2020 at our institution were retrospectively studied. We collected information on demographic data, clinical features, management aspects, and outcomes of PTL treatment. Kaplan-Meier survival curves and Cox regression analyses were used to study survival. Results: The median patient age was 69 years (interquartile range, 61-72 years). The most prevalent clinical presentation was testicular swelling (80%), and only 13.33% of the patients presented with systemic symptoms. Central nervous system involvement was detected in 6 patients (40%). Of the 15 patients, 5 (33.33%) had stage IE and 10 (66.67%) had stage IVE lymphoma. Diffuse large B-cell lymphoma was the most common histological subtype. Twelve patients (80%) received chemotherapy. During follow-up, 4 patients (26.67%) relapsed. The recurrence rate in the contralateral testicle was 13.33%. The median cancer-specific survival was 21.58 months (95% confidence interval, 0-43.95 months). Univariate Cox regression analysis showed that central nervous system involvement and International Prognostic Index score were significantly associated with shorter cancer-specific survival. Conclusions: Primary testicular lymphoma has a high relapse rate and poor prognosis. Management strategies typically include radical orchiectomy and systemic chemotherapy. Central nervous system involvement and International Prognostic Index scores were associated with lymphoma-specific survival.

Prevention of incisional hernia after kidney transplantation: study protocol for a randomized controlled trial.

BACKGROUND: Incisional hernia is a common complication after kidney transplantation with an incidence of 1.6-18%. Concerning non-transplant patients, a recently published meta-analysis describes a reduction of the incidence of incisional hernia of up to 85% due to prophylactic mesh replacement in elective, midline laparotomy. The aim of our study is to show a reduction of the incidence of incisional hernia after kidney transplantation with minimal risk for complication. METHODS/DESIGN: This is a blinded, randomized controlled trial comparing time to incisional hernia over a period of 24 months between patients undergoing kidney transplantation and standardized abdominal closure with or without prophylactic placement of ProGrip™ (Medtronic, Fridley, MN, USA) mesh in an onlay position. As we believe that the mesh intervention is superior to the standard procedure in reducing the incidence of hernia, this is a superiority trial. DISCUSSION: The high risk for developing incisional hernia following kidney transplantation might be reduced by prophylactic mesh placement. ProGrip™ mesh features polylactic acid (PLA) microgrips that provide immediate, strong and uniform fixation. The use of this mesh combines the effectiveness demonstrated by the macropore propylene meshes in the treatment of incisional hernias, a high simplicity of use provided by its capacity for self-fixation that does not increase significantly surgery time, and safety. TRIAL REGISTRATION: ClinicalTrials.gov NCT04794582. Registered on 08 March 2021. Protocol version 2.0. (02-18-2021).

Schwannoma of the seminal vesicle: Case report and review of the literature.

Seminal vesicles can be affected by tumours originating in other locations. However, primary tumours of the seminal vesicle are extremely rare, with less than 100 cases reported in literature. Seminal vesicle adenocarcinoma is the most common type, but there are also other malign lesions. Diagnosis is challenging due to the lack of early symptoms and well-defined criteria. These tumours are usually asymptomatic and discovered incidentally during imaging tests or pelvic surgery. Definitive diagnosis requires anatomopathological analysis. Case report of 58-years-old man with schwannoma of the seminal vesicle. We describe the main characteristics of these tumours as well as their therapeutic approach.

Vascular closure devices in living-donor nephrectomy: a much-needed systematic review and meta-analysis focusing on safety.

OBJECTIVE: To assess the safety of vascular closure devices in living-donor nephrectomy (LDN), as staplers and non-transfixion techniques (polymer locking and metal clips) are the methods employed to secure the renal vessels during laparoscopic and robotic LDN, but the use of clips has come into question since the United States Food and Drug Administration and manufacturers issued a contraindication. METHODS: A systematic review and meta-analysis were conducted to assess the safety of vascular closure devices (International Prospective Register of Systematic Reviews [PROSPERO] registration: CRD42022364349). The PubMed, Scopus, the Excerpta Medica dataBASE (EMBASE), and the Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS) databases were searched in September 2022. For comparative and non-comparative studies, incidence estimates and odds ratios (ORs), respectively, for the main variables regarding safety of vascular closure devices were pooled by using random effects meta-analyses. Quality assessment of the included comparative studies was conducted using the Risk Of Bias In Non-randomised Studies of Interventions (ROBINS-I) tool. RESULTS: Of the 863 articles obtained, data were retrieved from 44 studies, which included 42 902 patients. In non-comparative studies, the pooled estimate rates for device failure, severe haemorrhage rate, conversion to open surgery, and mortality were similar for both clips and staplers. Regarding the meta-analyses for comparative studies (three studies), there were no significant differences between the two groups for the severe haemorrhage rate (OR 0.57, 95% confidence interval [CI] 0.18-1.75; P = 0.33), conversion to open surgery (OR 0.35, 95% CI 0.08-1.54; P = 0.16), or death rate (OR 3.64, 95% CI 0.47-28.45; P = 0.22). Based on weak evidence, device failure was lower in the polymer clip group (OR 0.41, 95% CI 0.23-0.75; P = 0.00). CONCLUSIONS: This study has confirmed that there is no evidence for the superiority of any vascular closure device in terms of safety in LDN. Standardised recommendations for vascular control in this context should be carefully designed and prospectively evaluated.

Long-term Recurrence and Progression Patterns in a Contemporary Series of Patients with Carcinoma In Situ of the Bladder With or Without Associated Ta/T1 Disease Treated with Bacillus Calmette-Guérin: Implications for Risk-adapted Follow-up.

BACKGROUND: Limited data are available on patients with carcinoma in situ (CIS) of the bladder managed according to current clinical practice guidelines. OBJECTIVE: To assess the patterns of recurrence, progression to muscle-invasive bladder cancer (MIBC), and upper tract urothelial carcinoma (UTUC) in patients with CIS, and to compare the effectiveness of adequate versus inadequate bacillus Calmette-Guérin (BCG) immunotherapy. DESIGN, SETTING, AND PARTICIPANTS: A retrospective analysis of 386 patients with CIS of the bladder with or without associated pTa/pT1 disease treated with BCG between 2008 and 2015. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Kaplan-Meier estimations and an inverse probability of treatment weighting (IPTW)-Cox regression were performed to compare recurrence-free survival (RFS) and progression-free survival (PFS) and UTUC incidence over time for patients who received adequate versus inadequate BCG treatment. RESULTS AND LIMITATIONS: The median follow-up was 70.5 mo. At 5 and 10 yr, RFS was 82% and 52%, PFS was 93.6% and 75.8%, and UTUC incidence was 1.7% and 2.9%, respectively. Most recurrence (73.6%) and progression (69.1%) events occurred in the first 3 yr of follow-up, while 38.7% of UTUC incident events were recorded after 5 yr of follow-up. IPTW-Cox regression revealed that patients who received BCG treatment had a lower risk of recurrence (hazard ratio [HR] 0.21, 95% confidence interval [CI] 0.13-0.34), progression (HR 0.46, 95% CI 0.25-0.87), and UTUC incidence (HR 0.24, 95% CI 0.09-0.64). Limitations include the retrospective design and potential selection bias. CONCLUSIONS: Patients with CIS of the bladder show a high risk of recurrence, progression, and UTUC incidence. Most of these outcomes occur during the first 3 yr of follow-up, but a significant proportion of the events occur at long-term follow-up. Although receipt of adequate BCG treatment improves outcomes, intensive and long-term surveillance may be warranted. PATIENT SUMMARY: We investigated the long-term cancer control outcomes for patients with carcinoma in situ (CIS; cancerous cells that have not spread from where they first formed) of the bladder. Patients with CIS have a high risk of cancer recurrence and progression. Treatment with bacillus Calmette-Guérin (BCG) improves outcomes.

Prospective long-term experience in the treatment of renal tumors with cryotherapy: follow-up with computed tomography scan and contrast-enhanced ultrasound.

Introduction: The aim of this article was to evaluate the oncological results and safety of cryotherapy for the treatment of renal tumors. Material and methods: This study was a prospective review and follow-up of patients who underwent cryotherapy from January 2008 to May 2021. Cryotherapy was offered to patients with bilateral tumors, tumors in solitary kidneys, or comorbid patients. Follow-up consisted of a computed tomography (CT) scan and contrast-enhanced ultrasound (CEUS), with analysis of concordance (kappa index). Overall survival and kidney survival were analyzed (Kaplan-Meier). Results: Cryotherapy was performed 71 times in 67 patients. A total of 74.6% of patients were men. The mean age of patients was 69.7 years (standard deviation (SD) 11.3]. Mean follow-up was 52.7 months (SD 36.2). Mean tumor size was 26.2 mm (SD 7.6). 90% were cT1a, 10% cT1b stage. Type of access was open in 1 patient, laparoscopic in 8, percutaneous US-guided in 8 and percutaneous CT-guided in 54 patients. Biopsy was taken in 60 patients (84.5%) and consisted of renal cell carcinoma (22), oncocytoma (9), papillary carcinoma (4), angiomyolipoma (1), sarcoma (1), and non-conclusive (23).There were 22 complications such as pain in 2 patients, hematoma in 8 and 2 cases of bleeding, all resolved conservatively except for one case of bleeding which required embolization.Recurrences occurred in 16 cases (22.5%). Management was cryotherapy in 25%, radical nephrectomy in 31.3% and surveillance in 43.8%. Concordance between contrast-enhanced ultrasound and CT was 0.8 (excellent).Mean glomerular filtration did not change. One patient developed metastasis.No cancer-specific mortality was found. Overall survival at 12, 24 and 48 months was 98.5%, 96.8% and 76.9% respectively. Kidney survival at 12, 24 and 48 months was 97%, 93.5% and 93.5% respectively. Conclusions: Cryotherapy for renal tumors is a safe treatment for comorbid or solitary kidney patients, with rare major complications and good oncological outcome.

Medicines in exceptional circumstances for solid tumours: focusing on evidence, effectiveness, and toxicity profiles.

OBJECTIVE: To analyse the applications for drugs in special situations (compassionate use, off-label use and foreign drugs) for solid  tumours, and to assess the level of evidence supporting these applications, as  well as the effectiveness and safety of most frequent drugs. METHOD: We performed a cross-sectional study of all applications for drugs in  special situations during 2018 and 2019 in a representative third-level centre.  We collected data about generic names of drugs, clinical indications, and level  of evidence provided on the application form. Furthermore, tumour response  was assessed according to the Response Evaluation Criteria in Solid Tumours  version 1.1., Progression Free Survival and Overall Survival. Safety was  evaluated with the National Cancer Institute Common Terminology Criteria for  Adverse Events, version 5.0. RESULTS: 2,273 drugs in special situations were approved between January  2018 and December 2019. In 431 cases (19%), they were used to treat solid  tumours. Out of 431, 291 (67.5%) applications were offlabel drugs, 76 (18%)  foreign drugs, and 64 (15%) were compassionate use of drugs. Most of them  were supported by phase 3 (47%) or phase 2 (33%)  clinical trials. The  majority of adverse effects were grade 1 and only in 6/67 cases the treatment  was discontinued due to toxicity. CONCLUSIONS: A significant number of drugs in special situations are prescribed  to Oncology patients. The majority of applications of these drugs was supported by clinical trials. The real-life experience showed an effectiveness and tolerance profile similar to those described in randomised  clinical trials.

OBJETIVO: Analizar las solicitudes de medicamentos en situaciones especiales (uso compasivo, uso fuera de indicación y medicamentos  extranjeros) para tumores sólidos, y evaluar el nivel de evidencia que avala  dichas solicitudes, así como la efectividad y seguridad de los medicamentos  más frecuentes.Método: Estudio transversal que incluyó las solicitudes de medicamentos en  situaciones especiales durante el período 2018-2019 en un centro representativo español de tercer nivel. Se recogieron datos sobre  principios activos, indicaciones clínicas y nivel de evidencia aportado en la  solicitud. Asimismo, la respuesta tumoral fue evaluada mediante criterios  Response Evaluation Criteria in Solid Tumours versión 1.1, supervivencia libre  de progresión y supervivencia global. La seguridad fue evaluada con la versión 5.0 de los criterios de toxicidad Common Terminology Criteria for  Adverse Events del National Cancer Institute de Estados Unidos. RESULTADOS: Un total de 2.273 medicamentos en situaciones especiales fueron aprobados entre enero de 2018 y diciembre de 2019. El 19% (431) se  aprobaron para el tratamiento de tumores sólidos. De estos 431, 291 (67,5%)  solicitudes fueron de medicamentos fuera de indicación, 76 (18%) extranjeros  y 64 (15%) en uso compasivo. La mayoría son avaladas por estudios clínicos  aleatorizados en fase III (47%) o fase II (33%). La mayor parte de los efectos  adversos fueron de grado 1 y solo en 6/67 casos el tratamiento fue  interrumpido por toxicidad. CONCLUSIONES: Un porcentaje importante de medicamentos en usos especiales se prescriben a pacientes oncológicos. La mayoría de las solicitudes fueron  avaladas por algún estudio clínico aleatorizado. La experiencia en vida real  mostró un perfil de efectividad y tolerancia similar al descrito en los estudios  clínicos aleatorizados.

Kidney Autotransplantation and Orthotopic Kidney Transplantation: Two Different Approaches for Complex Cases.

Introduction: Transplantation surgery teams often have to face complex cases. In certain circumstances, such as occlusion of the iliac vessels or prior pelvic surgery, heterotopic kidney transplantation may not be feasible and orthotopic kidney transplantation (OKT) could be a good alternative. Kidney autotransplantation (KAT) has been described as a potential treatment for complex renovascular, ureteral, or neoplastic conditions. There are scarce data regarding the complications and outcomes of these procedures; therefore, we present our experience. Materials and Methods: We retrospectively analysed the medical records of both 21 patients who had received OKT and 19 patients who underwent KAT between 1993 and 2020. We collected demographic features and data regarding surgical technique, complications, and graft outcomes. Kidney graft survival was calculated using Kaplan-Meier survival analysis. Results: Regarding OKT, in 15 (71.43%) cases, it was the first kidney transplantation. The most common indication was the unsuitable iliac region due to vascular abnormalities (57.14%). The early postoperative complication rate was high (66.67%), with 23.81% of Clavien grade 3b complications. During the follow-up period (mean 5.76 -SD 6.15- years), we detected 9 (42.85%) graft losses. At 1 year, the survival rate was 84.9%. Concerning KAT, the most frequent indication was ureteral pathology (52.63%), followed by vascular lesions (42.11%). The overall early complication rate was 42.11%. During the follow-up period (mean of 4.47 years), 4 (15.79%) graft losses were reported. Conclusions: Although OKT and KAT have high complication rates, these techniques can be considered as two valuable approaches for complex cases, in the absence of other therapeutic options.

Kidney Autotransplantation in the Management of Residual Retroperitoneal Mass in a Germ Cell Tumor.

The main indication for kidney autotransplantation is ureteric disease, although it is also performed to treat renovascular diseases or neoplasms, such as complex intrasinusal kidney tumors or in patients with a solitary kidney. Only a few cases of kidney autotransplantation in the context of resection of complex retroperitoneal masses have been reported in the literature. CASE PRESENTATION: We report the case of a 26-year-old man with history of nonseminomatous germ cell tumor who had undergone a left radical orchiectomy 3 months earlier. Follow-up computed tomography revealed a residual retroperitoneal postchemotherapy mass involving the renal hilum. It was surgically removed via en bloc resection and bench ex vivo nephron-sparing surgery, and subsequently autotransplantation, thereby avoiding the necessity of nephrectomy and the resulting risk of chronic kidney disease. The pathology of the excised specimen demonstrated mixed germ cell tumor, composed of immature teratoma and yolk sac tumor, and confirmed tumor-free margins. CONCLUSIONS: This technique should be taken into account in selected patients as an alternative to radical nephrectomy when a retroperitoneal tumor is unresectable using standard surgical techniques or when a radical nephrectomy is considered, especially in patients with chronic kidney disease or solitary kidney, or in young patients who will potentially need nephrotoxic chemotherapy.

Medicamentos en situaciones especiales paratumores sólidos: profundizando en la evidencia y los perfiles de efectividad y toxicidad / Medicines in exceptional circumstances for solid tumours: focusing on evidence, effectiveness, and toxicity profiles

Objetivo: Analizar las solicitudes de medicamentos en situaciones especiales(uso compasivo, uso fuera de indicación y medicamentos extranjeros) paratumores sólidos, y evaluar el nivel de evidencia que avala dichas solicitudes,así como la efectividad y seguridad de los medicamentos más frecuentes.Método: Estudio transversal que incluyó las solicitudes de medicamentosen situaciones especiales durante el período 2018-2019 en un centrorepresentativo español de tercer nivel. Se recogieron datos sobre principiosactivos, indicaciones clínicas y nivel de evidencia aportado en la solicitud.Asimismo, la respuesta tumoral fue evaluada mediante criterios ResponseEvaluation Criteria in Solid Tumours versión 1.1, supervivencia libre de progresióny supervivencia global. La seguridad fue evaluada con la versión5.0 de los criterios de toxicidad Common Terminology Criteria for AdverseEvents del National Cancer Institute de Estados Unidos.Resultados: Un total de 2.273 medicamentos en situaciones especialesfueron aprobados entre enero de 2018 y diciembre de 2019. El19% (431) se aprobaron para el tratamiento de tumores sólidos. De estos431, 291 (67,5%) solicitudes fueron de medicamentos fuera de indicación,76 (18%) extranjeros y 64 (15%) en uso compasivo. La mayoría son avaladas por estudios clínicos aleatorizados en fase III (47%) o fase II(33%). La mayor parte de los efectos adversos fueron de grado 1 y soloen 6/67 casos el tratamiento fue interrumpido por toxicidad.Conclusiones: Un porcentaje importante de medicamentos en usosespeciales se prescriben a pacientes oncológicos. La mayoría de lassolicitudes fueron avaladas por algún estudio clínico aleatorizado. Laexperiencia en vida real mostró un perfil de efectividad y tolerancia similaral descrito en los estudios clínicos aleatorizados.

Objective: To analyse the applications for drugs in special situations(compassionate use, off-label use and foreign drugs) for solid tumours, andto assess the level of evidence supporting these applications, as well asthe effectiveness and safety of most frequent drugs.Method: We performed a cross-sectional study of all applications fordrugs in special situations during 2018 and 2019 in a representativethird-level centre. We collected data about generic names of drugs,clinical indications, and level of evidence provided on the applicationform. Furthermore, tumour response was assessed according to the ResponseEvaluation Criteria in Solid Tumours version 1.1., Progression FreeSurvival and Overall Survival. Safety was evaluated with the NationalCancer Institute Common Terminology Criteria for Adverse Events, version5.0.Results: 2,273 drugs in special situations were approved betweenJanuary 2018 and December 2019. In 431 cases (19%), they were usedto treat solid tumours. Out of 431, 291 (67.5%) applications were offlabeldrugs, 76 (18%) foreign drugs, and 64 (15%) were compassionate use ofdrugs. Most of them were supported by phase 3 (47%) or phase 2 (33%) clinical trials. The majority of adverse effects were grade 1 and only in6/67 cases the treatment was discontinued due to toxicity.Conclusions: A significant number of drugs in special situations areprescribed to Oncology patients. The majority of applications of thesedrugs was supported by clinical trials. The real-life experience showed aneffectiveness and tolerance profile similar to those described in randomisedclinical trials.

[Renal allograft transplant vascular complications. Diagnostic and treatment.] / Complicaciones vasculares del trasplante renal. Diagnóstico y tratamiento.

Vascular complications remain common after renal transplantation, occurring in 3% to 15% of patients. These complications can compromise graft function,with graft loss rates ranging from 12.6 to 66.7%.Vascular abnormalities of the graft, specifically the presence of multiple vessels, represent the most frequently studied risk factor for the development of vascular complications. Other risk factors identified for the development of vascular complications are linked to the characteristics of the recipient, or thromboembolic diseasesharing atherosclerosis and/or hypercoagulant state aspathogenic features.Although the most frequent vascular complication is renal artery stenosis, we will also address the complications according to their early or late on set in order to highlightthe potentially more severe complications that may affectgraft survival during the follow-up period.Early vascular complications include mainly arterial and venous thrombosis and lacerations or disruptions of artery and/or vein, as well as arterio-venous fistulas or intrarenal pseudoaneurysms. In contrast, late-onset complications include stenosis or kinking of the renal artery-and less commonly of the renal vein-, as well as extrinsic compression as a consequence of the presence of perigraft fluid collections. Finally, extrarenal pseudoaneurysm is a potentially severe complication in the late post-transplant period.Finally, this article explores special transplant situations such as complications derived from the paediatric donor in adult recipients, transplantation in the paediatric recipient and emerging techniques like robotic renal transplantation.

Las complicaciones vasculares siguen siendo frecuentes después del trasplante renal, ocurriendo entre el 3% y el 15% de los pacientes. Estas complicaciones pueden comprometer la función del injerto,con unas tasas de pérdida del injerto que varían entreel 12,6 ­ 66,7%.Las anomalías vasculares del injerto, y concretamente la presencia de múltiples vasos, representan el factor de riesgo más frecuente y estudiado para el desarrollo de complicaciones vasculares. Otros factores de riesgo de complicaciones vasculares se han relacionado con las características del receptor, o la enfermedad tromboembólica, compartiendo como características patogénicas la aterosclerosis y/o el estado hipercoagulante. Aunque la complicación vascular más frecuente está constituida por la estenosis de la arteria renal, expondremos las complicaciones en función de su presentación clínica temprana o tardía en un intento de destacar para el lector las complicaciones potencialmente más severas y que en cada momento del tiempo pueden condicionar la supervivencia del injerto.Las complicaciones de presentación preferentemente perioperatoria incluyen fundamentalmente la trombosis arterial y venosa y las laceraciones o disrupciones de arteria y/o vena, así como las fístulas arterio-venosas opseudoaneurismas intrarrenales. Por el contrario, otras complicaciones tienen comúnmente una presentación clínica más tardía. En este grupo incluimos la estenosiso acodamiento de la arteria renal y excepcionalmente de la vena renal, así como la compresión extrínseca de los vasos del injerto como consecuencia de la presencia de colecciones peri-injerto. Finalmente, una complicación severa que puede manifestarse de forma tardía enla evolución del receptor, es el pseudoaneurisma extrarrenal. Finalmente, haremos brevemente referencia a situaciones especiales del trasplante como las complicaciones derivadas del donante pediátrico en receptores adultos,del trasplante en el receptor pediátrico y de técnicas emergentes como el trasplante renal robótico.

Primary epithelioid hemangioendothelioma of the penis: a case report and literature review.

Epithelioid hemangioendothelioma (EHE) is a rare vascular tumour with an intermediate behaviour between benign hemangioma and malignant angiosarcoma. There is scarce data on the penile EHE's management and its natural history, as our knowledge is based on few reported cases with a short follow-up period. We present a case report and conducted a literature review, including 17 cases. The relevance of this case report derives from the need for better clinical characterization of patients with penile EHE and the importance of defining the outcomes. We report the case of a 53-year-old male with a 1-year history of sleep-related painful erections. Imaging techniques showed a well-defined hypoechoic and hypervascular solid nodule on the dorsal aspect of the penis. It was surgically removed, and the histopathological study revealed a low-risk EHE of the penis. Follow-up magnetic resonance imaging (MRI) and computed tomography did not demonstrate local recurrence nor metastases. According to the literature review, most of the patients were in their fifth and sixth decades of life at the time of diagnosis and lesions were usually located in the glans. The most common clinical presentation was as a painful mass. Follow-up period ranged from 2 months to 5 years. Three patients showed systemic metastases, two of which died due to cancer. The conclusions from the literature review are limited by the reduced number of cases and the short follow-up. This case report highlights the importance of understanding the diagnosis and treatment of this type of rare non-squamous malignant tumours of the penis. Penile EHE is a malignant vascular tumour that is very rare in this location. The best treatment is local excision, with re-excision or intraoperative margins assessment. Occasionally, systemic chemotherapy and radiation therapy can be useful. There is consensus on the importance of very strict follow-up of these patients.

Identifying Risk Factors for MRI-Invisible Prostate Cancer in Patients Undergoing Transperineal Saturation Biopsy.

PURPOSE: Prostatic multi-parametric magnetic resonance imaging (mpMRI) has markedly improved the assessment of men with suspected prostate cancer (PCa). Nevertheless, as mpMRI exhibits a high negative predictive value, a negative MRI may represent a diagnostic dilemma. The aim of this study was to evaluate the incidence of positive transperineal saturation biopsy in men who have negative mpMRI and to analyse the factors associated with positive biopsy in this scenario. PATIENTS AND METHODS: A retrospective study of men with normal mpMRI and suspicion of PCa who underwent saturation biopsy (≥20 cores) was carried out. A total of 580 patients underwent transperineal MRI/transrectal ultrasound fusion targeted biopsies or saturation prostate biopsies from January 2017 to September 2020. Of them, 73 had a pre-biopsy negative mpMRI (with Prostate Imaging - Reporting and Data System, PI-RADS, ≤2) and were included in this study. Demographics, clinical characteristics, data regarding biopsy results and potential predictive factors of positive saturation biopsy were collected. Univariate and multivariate logistic regression analyses were used to identify independent risk factors for MRI-invisible PCa. RESULTS: The detection rate of PCa with saturation biopsy in patients with negative MRI was 34/73 (46.58%). Out of 34 MRI-invisible prostate cancers detected, 12 (35.29%) were clinically significant PCa (csPCa) forms. Regarding factors of positive biopsy, in univariate analysis, the use of 5-alpha reductase inhibitors and free:total prostate-specific antigen (PSA) ratio were associated with the result of the saturation biopsy. In multivariate analysis, only an unfavourable free:total PSA ratio remained a risk factor (OR 11.03, CI95% 1.93-63.15, p=0.01). Furthermore, multivariate logistic analysis demonstrated that prostate volume >50mL significantly predicts the absence of csPCa on saturation biopsy (OR 0.11, 95% CI 0.01-0.94, p=0.04). CONCLUSION: A free:total PSA ratio <20% is a risk factor for MRI-invisible PCa. Saturation biopsy could be considered in patients with suspected PCa, despite having a negative MRI.

Comparison of in situ preservation techniques for kidneys from donors after circulatory death: a systematic review and meta-analysis.

BACKGROUND: Several techniques have been developed to reduce the warm ischaemic injury of donation after circulatory death (DCD) organs before procurement. There are scarce data about the in situ preservation techniques for kidney graft outcomes. The aim of this systematic review was to evaluate the best in situ preservation method for kidney graft outcomes from organs obtained from controlled and uncontrolled DCD. METHODS: A systematic review of the PubMed (MEDLINE), Embase, LILACS and Cochrane databases was conducted. Studies that compare two or more in situ preservation techniques were identified and included. Only studies which provided enough data to calculate odds ratio were eligible for meta-analysis. PROSPERO registration: CRD42020179598. RESULTS: The search strategy yielded 7,121 studies. Ultimately, 14 retrospective studies were included. Because of heterogeneity, the included studies provided weak evidence that normothermic regional perfusion (NRP) is the best in situ preservation technique in terms of delayed graft function (DGF) rates. Regarding primary nonfunction (PNF), we carried out a meta-analysis of 10 studies with a pooled OR of 0.83 (95% CI: 0.40-1.71), for the NRP. In regard to DGF, pooled OR for NRP was 0.36 (95% CI: 0.25-0.54). CONCLUSIONS: NRP in the DCD donor could improve kidney graft function and be considered the in situ preservation technique of choice for abdominal organs.

Spontaneous urinoma debuting as retroperitoneal abscess: report of 2 cases and literature review.

Spontaneous urinoma is a urological entity that can be complicated by a retroperitoneal abscess. Urinoma can be iatrogenic, traumatic, or can be caused by obstructive uropathy. We report two cases of spontaneous urinomas, describing a not previously published cause of urinoma: pyeloureteritis. (I) A 55-year-old Caucasian female started with intense left-sided flank pain for 3 days. CT scan revealed a voluminous retroperitoneal abscess, which extended through the posterior pararenal space and the left lumbar paravertebral musculature. (II) A 48-year-old Caucasian male presented with constitutional symptoms over the previous 2 months and investigations showed a voluminous urinoma and marked pyeloureteritis findings on CT scan. Both patients were managed by endoscopic placement of a double-J stent and drainage of the collection (open and percutaneous approach, respectively). Urinoma was confirmed by fluid biochemical analysis, which demonstrated that fluid creatinine was markedly raised as compared to the serum creatinine. Urinoma in the absence of obstruction or trauma is rare. These two case reports highlight one of the conditions leading to urinoma and the management of retroperitoneal abscess. Pyeloureteritis is a cause of spontaneous urinoma and it should be considered in the lack of another obstructive cause.

Well-Leg Compartment Syndrome After Percutaneous Nephrolithotomy in the Galdakao-Modified Supine Valdivia Position.

PURPOSE: The objective is to present a case of well-leg compartment syndrome in the Galdakao-modified supine Valdivia position. RESULTS: The case of a 32-year-old male, obese (105 Kg) and a former smoker is presented. The patient was positioned in the Galdakao-modified supine Valdivia position, with lower limbs bandaged, to perform a right percutaneous nephrolithotomy. In the immediate postoperative period, significant pain was reported in the left lower limb. The limb appeared oedematous and cyanotic, although pedis pulses were preserved. Doppler ultrasound ruled out venous thrombosis. Suspecting compartment syndrome, the patient underwent a complete decompression fasciotomy of the four left leg compartments. After the surgery, values of creatine phosphokinase reached 80.000 UI/L and serum creatinine levels were 1.53 mg/dL. The patient was taken to the intensive care unit. Six months after the episode, the patient still needs rehabilitation care. The compartment syndrome is a rare complication in lithotomy position, but never described in the Galdakao-modified supine Valdivia position before, with the lower limbs in moderate flexion, and with the ipsilateral lower limb in a slightly inferior position with respect to the other. It may lead to skin necrosis, permanent neuromuscular dysfunction, myoglobinuric renal failure, amputation and even death. Therefore, this complication must be suspected and early decompression of the compartment must be performed. Risk factors include obesity, peripheral vascular disease (advanced age, hypertension, hyperlipidemia and diabetes mellitus), height, hypothermia, acidemia, BMI, male sex, combined general-spinal anesthesia, prolonged surgery time, systemic hypotension, ASA (American Society of Anesthesiologists) class, lack of operative experience, vasoconstricting drugs, important bleeding during the surgery and increased muscle bulk. CONCLUSION: Compartment syndrome is a potentially life-threatening complication that may occur in the Galdakao-modified supine Valdivia position. It should be suspected in cases with risk factors and compatible clinical symptoms and signs, and treated rapidly to avoid further complications.