Desarrollo y validación de un nuevo simulador para endourología / The development and validation of a new simulator for endourology

Introducción La simulación en medicina ha evolucionado sustancialmente en las últimas décadas. Actualmente hay una gran variedad de simuladores disponibles, especialmente diseñados para la práctica de procedimientos quirúrgicos. Debido a las largas curvas de aprendizaje de las técnicas endourológicas mínimamente invasivas, la rama de la endourología se puede ver muy beneficiada por el uso de estos simuladores. Material y métodos Se diseñó un simulador de baja fidelidad para la práctica de técnicas endourológicas que utilizan cistoscopia. En el proceso de validación participaron 5 expertos y 19 no expertos. Los expertos eran profesionales médicos de un Departamento de Urología con experiencia de al menos 100 procedimientos de cistoscopia flexible. Los no expertos eran residentes en medicina interna sin experiencia en ningún tipo de técnica endoscópica. Se recogió información sobre la validez aparente y de contenido mediante escalas de Likert con puntuación de 1 a 5. Para evaluar la validez de constructo, se midió el tiempo para completar dos tareas, para lo cual se evaluó el procedimiento mediante la escala de evaluación global OSATS. Resultados El nuevo simulador se fabricó satisfactoriamente de acuerdo con su diseño. En todos los aspectos evaluados de la validez de constructo hubo una diferencia significativa (p<0,05) entre el grupo de expertos y el de no expertos. La validez de contenido fue puntuada con 4,66 (desviación estándar [DE] ±0,56) por los expertos y con 4,41 (DE±0,71) por los no expertos. En el cuestionario de validez aparente, la puntuación media fue de 4,14 (DE±0,94), y la pregunta que recibió la puntuación más alta (4,6 [DE±0,84]) evaluaba la inmersión en el procedimiento. Conclusión El simulador presentado es válido tanto para el entrenamiento de nuevos endourólogos como para el perfeccionamiento de las técnicas de los médicos expertos (AU)

Introduction Simulation in medicine has developed a lot in the last few decades. There is a broad range of simulators available, above all for training in surgical procedures. Endourology can benefit much from simulation because the minimally-invasive procedures of endourology frequently have long learning curves, which can be reduced by training with simulators. Material and methods A low-fidelity simulator was designed for practicing endourology techniques that use cystoscopy. The process of validation involved 5 experts and 19 non-experts. Experts comprised medical professionals working in a department of urology who had performed at least 100 flexible cystoscopy procedures. Non-experts were residents in internal medicine without experience in any type of endoscopy. Information about face and content validity was collected by means of Likert scales from 1 to 5. To evaluate construct validity, we measured the time to complete two tasks, for which the procedure was evaluated by means of the OSATS global evaluation scale. Results New simulator was successfully built according to its design. For all evaluated aspects of construct validity, there was a significant difference (P<.05) between the group of experts and the group of non-experts. Content validity was scored 4.66 (standard deviation±0.56) by the experts and 4.41 (±0.71) by the non-experts. In the face validity questionnaire, the average score was 4.14 (±0.94), the question receiving the highest score: 4.6 (±0.84) concerned immersion in the procedure. Conclusion The simulator presented is valid both for training up new urologists in endourology technique and for experts seeking to perfect their skills (AU)

The development and validation of a new simulator for endourology.

INTRODUCTION: Simulation in medicine has developed a lot in the last few decades. There is a broad range of simulators available, above all for training in surgical procedures. Endourology can benefit much from simulation because the minimally-invasive procedures of endourology frequently have long learning curves, which can be reduced by training with simulators. MATERIALS AND METHODS: A low-fidelity simulator was designed for practicing endourology techniques that use cystoscopy. The process of validation involved 5 experts and 19 non-experts. Experts comprised medical professionals working in a department of urology who had performed at least 100 flexible cystoscopy procedures. Non-experts were residents in internal medicine without experience in any type of endoscopy. Information about face and content validity was collected by means of Likert scales from 1 to 5. To evaluate construct validity, we measured the time to complete two tasks, for which the procedure was evaluated by means of the OSATS global evaluation scale. RESULTS: New simulator was successfully built according to its design. For all evaluated aspects of construct validity, there was a significant difference (p<0.05) between the group of experts and the group of non-experts. Content validity was scored 4.66 (standard deviation ±0.56) by the experts and 4.41 (±0.71) by the non-experts. In the face validity questionnaire, the average score was 4.14 (±0.94), the question receiving the highest score: 4.6 (±0.84) concerned immersion in the procedure. CONCLUSION: The simulator presented is valid both for training up new urologists in endourology technique and for experts seeking to perfect their skills.

Análisis de cuestionario de salud y desarrollo de cuestionario de satisfacción en pacientes tratados con litotricia extracorpórea por ondas de choque (SATISLIT) / Health questionnaire analysis and development of satisfaction questionnaire for patients treated with extracorporeal shock wave lithotripsy (SATISLIT)

INTRODUCCIÓN: Debido a la ausencia de instrumentos específicos para estudiar la esfera psicosocial de los pacientes que reciben litotricia extracorpórea por ondas de choque (LEOC), el objetivo es desarrollar un cuestionario de satisfacción respecto al tratamiento recibido con LEOC a partir de un cuestionario de salud ya diseñado y validado previamente. MATERIAL Y MÉTODOS: El diseño del cuestionario de satisfacción se realizó en 5 fases a partir de una escala de salud en pacientes tratados con LEOC (ESPTL) ya validada previamente, utilizando una muestra total de 135 pacientes tratados en nuestro centro a los que se entrevistó por vía telefónica. En la fase 1 se realizó análisis descriptivo de la serie y de las puntuaciones de los 8 ítems de ESPTL. En la fase 2 se compararon las puntuaciones de ESPTL según sexo con U-Mann Whitney, estudiando la correlación con la edad mediante Rho de Spearman en la fase 3. En la fase 3 se compararon las puntuaciones de los factores de ESPTL según el sexo y se analizó la correlación con la edad al igual que en las fases 2 y 3 con la puntuación global. En la fase 5 se obtuvo la subescala de satisfacción-SATISLIT- y se realizó análisis descriptivo, comparación según sexo, correlación con la edad y modelo de regresión lineal con respecto a ESPTL. RESULTADOS: Ciento treinta y cinco pacientes, 85 (63%) hombres, 50 (37%) mujeres. Mediana (mínimo-máximo) de edad 56 (27-79) y puntuación ESPTL 31 (8-39). Diferencias en puntuación global ESPTL entre hombres y mujeres (p < 0,001), así como en los ítems 1 (p = 0,029), 3 (p = 0,002), 6 (p = 0,006), 7 (p = 0,005) y 8 (p = 0,025). Correlación no significativa de ESPTL con la edad. Significativa en ítems 2, 4, 5 y 8 pero correlación muy débil (< 0,2). Cuatrofactores con 2 ítems cada uno, con diferencias estadísticamente significativas según sexo en F2 (p = 0,001), F3 (p = 0,007) y F4 (p = 0,001). Correlación significativa con la edad únicamente en F1 y F3 pero muy débil (< 0,2). Mediana (mínimo-máximo) SATISLIT 18 (4-20). Diferencias estadísticamente significativas según sexo (p = 0,001). Correlación no significativa con la edad (p = 0,836). Regresión lineal de SATISLIT con respecto a ESPTL significativa (p < 0,001). CONCLUSIONES: El trabajo realizado a partir de un cuestionario validado de salud ha proporcionado un nuevo instrumento de evaluación de la satisfacción tras tratamiento con LEOC llamado SATISLIT. Serán necesarios futuros estudios de validación externa y validación temporal para contrastar su verdadera utilidad clínica

INTRODUCTION: Due to the absence of specific instruments to study the psychosocial sphere of patients undergoing extracorporeal shock wave lithotripsy (SWL), the objective of this study is to develop a satisfaction questionnaire regarding the SWL treatment from a health questionnaire which was already designed and had been previously validated. MATERIAL AND METHODS: The design of the satisfaction questionnaire was carried out in 5 phases, based on a previously validated health scale in patients treated with SWL (ESPTL), including a total cohort of 135 patients treated at our center who received a phone interview. Phase 1: descriptive analysis of the series and scores of the 8 items of ESPTL. Phase 2: U-Mann Whitney comparison of ESPTL based on the patients' sex. Phase 3: study of ESPTL correlation with age using Spearman's Rho. Phase 4: grouping by factors of ESPTL, comparison by sex and correlation with age, as performed in phases 2 and 3 with the global score. Phase 5: obtaining the satisfaction subscale -SATISLIT-, descriptive analysis, comparison according to sex, correlation with age and linear regression model of SATISLIT with respect to ESPTL. RESULTS: 135 patients, 85(63%) men, 50(37%) women. Median (minimum-maximum) age 56 (27-79) and ESPTL score 31 (8-39). Differences in global ESPTL score between men and women (p < .001), as well as in items 1 (p =.029), 3 (p = .002), 6 (p = .006), 7 (p = .005) and 8 (p = .025). Non-significant correlation of ESPTL regarding age. Significant correlation in items 2, 4, 5 and 8 but, very weak (< 0.2).4 factors, each one with 2 items, with statistically significant differences regarding sex in F2 (p = .001), F3 (p =.007) and F4 (p = .001). Significant correlation with age only in F1 and F3, but very weak (< 0.2). Median (minimum-maximum) SATISLIT 18 (4-20). Statistically significant differences regarding patients' sex (p =.001). Non- significant correlation with age (p =.836). Significant linear regression of SATISLIT with respect to ESPTL (p < .001). CONCLUSIONS: Based on validated health questionnaire, the present work has provided a new instrument called SATISLIT for assessing patients' satisfaction after treatment with SWL. Future studies with external and temporal validation will be necessary to contrast its real clinical usefulness

Health questionnaire analysis and development of satisfaction questionnaire for patients treated with extracorporeal shock wave lithotripsy (SATISLIT). / Análisis de cuestionario de salud y desarrollo de cuestionario de satisfacción en pacientes tratados con litotricia extracorpórea por ondas de choque (SATISLIT).

INTRODUCTION: Due to the absence of specific instruments to study the psychosocial sphere of patients undergoing extracorporeal shock wave lithotripsy (SWL), the objective of this study is to develop a satisfaction questionnaire regarding the SWL treatment from a health questionnaire which was already designed and had been previously validated. MATERIAL AND METHODS: The design of the satisfaction questionnaire was carried out in 5 phases, based on a previously validated health scale in patients treated with SWL (ESPTL), including a total cohort of 135 patients treated at our center who received a phone interview. Phase 1: descriptive analysis of the series and scores of the 8 items of ESPTL. Phase 2: U-Mann Whitney comparison of ESPTL based on the patients' sex. Phase 3: study of ESPTL correlation with age using Spearman's Rho. Phase 4: grouping by factors of ESPTL, comparison by sex and correlation with age, as performed in phases 2 and 3 with the global score. Phase 5: obtaining the satisfaction subscale -SATISLIT-, descriptive analysis, comparison according to sex, correlation with age and linear regression model of SATISLIT with respect to ESPTL. RESULTS: 135 patients, 85(63%) men, 50(37%) women. Median (minimum-maximum) age 56 (27-79) and ESPTL score 31 (8-39). Differences in global ESPTL score between men and women (p <.001), as well as in items 1 (p =.029), 3 (p =.002), 6 (p =.006), 7 (p =.005) and 8 (p =.025). Non-significant correlation of ESPTL regarding age. Significant correlation in items 2, 4, 5 and 8 but, very weak (<0.2). 4 factors, each one with 2 items, with statistically significant differences regarding sex in F2 (p =.001), F3 (p =.007) and F4 (p =.001). Significant correlation with age only in F1 and F3, but very weak (<0.2). Median (minimum-maximum) SATISLIT 18 (4-20). Statistically significant differences regarding patients' sex (p =.001). Non- significant correlation with age (p =.836). Significant linear regression of SATISLIT with respect to ESPTL (p <.001). CONCLUSIONS: Based on validated health questionnaire, the present work has provided a new instrument called SATISLIT for assessing patients' satisfaction after treatment with SWL. Future studies with external and temporal validation will be necessary to contrast its real clinical usefulness.

Predicción de efectividad de litotricia extracorpórea por ondas de choque en cálculos del tracto urinario. Grupos de riesgo para precisar retratamiento / Predicting the effectiveness of extracorporeal shock wave lithotripsy on urinary tract stones. Risk groups for accurate retreatment

Introducción: La litotricia extracorpórea por ondas de choque (LEOC) es un tratamiento no invasivo, seguro y efectivo para las litiasis del tracto urinario cuya efectividad varía según la localización y el tamaño del cálculo, entre otros factores; en ocasiones es necesario realizar varias sesiones. El objetivo es tratar de predecir el éxito o fracaso conociendo previamente las variables influyentes. Material y métodos: Analizamos a 211 pacientes con TAC previa entre aquellos tratados mediante LEOC entre los años 2010 y 2014. Se estudian las variables influyentes en la necesidad de retratamiento utilizando modelos de regresión logística binaria (estudio uni- y multivariado): densidad máxima, diámetro máximo, área, localización, desintegración y distancia del panículo adiposo. Con las variables influyentes se ha diseñado un modelo de riesgo valorando con regresión logística todas las posibles combinaciones (IBM SPSS versión 20.0). Resultados: Las variables de influencia independiente en la necesidad de retratamiento son: densidad máxima >864UH, diámetro máximo >7,5mm y localización pielocalicial. Utilizando estas variables, el mejor modelo incluye 3grupos de riesgo con probabilidades de necesitar retratamiento significativamente diferentes: grupo 1-bajo riesgo (0 variables) con 20,2%, grupo 2-riesgo intermedio (1-2 variables) con 49,2% y grupo 3-alto riesgo (3 variables) con 62,5%. Conclusiones: La densidad, el diámetro máximo y la localización pielocalicial del cálculo son factores determinantes en la efectividad del tratamiento con LEOC. Con estas variables, que se pueden obtener antes de la decisión terapéutica, el modelo de riesgo diseñado permite una aproximación precisa de cara a elegir el tratamiento más adecuado para cada caso en particular

Introduction: Extracorporeal shock wave lithotripsy (ESWL) is a non-invasive, safe and effective treatment for urinary tract lithiasis. Its effectiveness varies depending on the location and size of the stones as well as other factors; several sessions are occasionally required. The objective is to attempt to predict its success or failure, when the influential variables are known beforehand. Material and methods: We analysed 211 patients who had had previous CT scans and were treated with ESWL between 2010 and 2014. The influential variables in requiring retreatment were studied using binary logistic regression models (univariate and multivariate analysis): maximum density, maximum diameter, area, location, disintegration and distance from the adipose panniculus. With the influential variables, a risk model was designed by assessing all possible combinations with logistic regression (version 20.0 IBM SPSS). Results: The independent influential variables on the need for retreatment are: maximum density > 864 HU, maximum diameter > 7.5 mm and pyelocaliceal location. Using these variables, the best model includes 3risk groups with a probability of requiring significantly different retreatment: group 1-low risk (0 variables) with 20.2%; group 2-intermediate risk (1-2 variables) with 49.2%; and group 3-high risk (3 variables) with 62.5%. Conclusions: The density, maximum diameter and pyelocaliceal location of the stones are determinant factors in terms of the effectiveness of treatment with ESWL. Using these variables, which can be obtained in advance of deciding on a treatment, the designed risk model provides a precise approach in choosing the most appropriate treatment for each particular case

Predicting the effectiveness of extracorporeal shock wave lithotripsy on urinary tract stones. Risk groups for accurate retreatment. / Predicción de efectividad de litotricia extracorpórea por ondas de choque en cálculos del tracto urinario. Grupos de riesgo para precisar retratamiento.

INTRODUCTION: Extracorporeal shock wave lithotripsy (ESWL) is a non-invasive, safe and effective treatment for urinary tract lithiasis. Its effectiveness varies depending on the location and size of the stones as well as other factors; several sessions are occasionally required. The objective is to attempt to predict its success or failure, when the influential variables are known beforehand. MATERIAL AND METHODS: We analysed 211 patients who had had previous CT scans and were treated with ESWL between 2010 and 2014. The influential variables in requiring retreatment were studied using binary logistic regression models (univariate and multivariate analysis): maximum density, maximum diameter, area, location, disintegration and distance from the adipose panniculus. With the influential variables, a risk model was designed by assessing all possible combinations with logistic regression (version 20.0 IBM SPSS). RESULTS: The independent influential variables on the need for retreatment are: maximum density >864HU, maximum diameter >7.5mm and pyelocaliceal location. Using these variables, the best model includes 3risk groups with a probability of requiring significantly different retreatment: group 1-low risk (0 variables) with 20.2%; group 2-intermediate risk (1-2 variables) with 49.2%; and group 3-high risk (3 variables) with 62.5%. CONCLUSIONS: The density, maximum diameter and pyelocaliceal location of the stones are determinant factors in terms of the effectiveness of treatment with ESWL. Using these variables, which can be obtained in advance of deciding on a treatment, the designed risk model provides a precise approach in choosing the most appropriate treatment for each particular case.

[Prostatic carcinoma. Radical prostatectomy. Impact of neoadjuvant hormonal treatment]. / Carcinoma de próstata. Prostatectomía radical. Influencia del tratamiento hormonal neoadyuvante.

OBJECTIVE: To assess the influence of neo-adjuvant hormone therapy on the pathologic stage, margins and disease-free survival in patients with T1-T2 prostate cancer after radical prostatectomy. MATERIAL AND METHODS: Forty-two non-randomised, T1-T2 patients who underwent complete neo-adjuvant blockade and radical prostatectomy between 1988-1998 were included in the study. This group is part of a larger cohort of 220 T1-T2 patients treated with radical surgery. The group is compared to: a) the remaining patients (178) (Group I) and b) a selected group (54 patients) of consistent characteristics relative to clinical variables (Group II). Mean follow-up: 35 months; median: 32 months. RESULTS: Compared to Group I patients with neo-adjuvant therapy show worse Gleason (p: 0.01), worse clinical stage (p: 0.02), higher rate of patients with high clinical risk (p: 0.03), and higher PSA (though not statistically different). No differences were seen relative to pathological status or margins. Compared to Group II (54 patients) no differences are found in clinical or pathological variables. Groups are comparable in terms of progression-free survival. CONCLUSIONS: Neo-adjuvant hormone therapy in high clinical risk, T1-T2 patients does not involve improvement in pathological stage, margins or progression-free survival.

[Radical prostatectomy in stage pT3C stage prostatic adenocarcinoma]. / Prostatectomía radical en adenocarcinoma de próstata estadio pT3C.

OBJECTIVES: To assess the efficacy of surgery in pT3c patients; to discern whether this is an independent influential factor for survival and clinical factor for diagnostic prediction. MATERIAL AND METHODS: Forty-five pT3c (TNM 1982) patients from a cohort of 220 subjects with T1-T2 prostate cancer who underwent radical prostatectomy. Mean and median follow-up: 42 and 36 months, respectively. RESULTS: pT3 stage accounts for 20% (45/220) patients. They display a significantly higher mean PSA (25 +/- 2 ng/ml) (0.001), worse Gleason (0.0002) and clinical stage (0.0003), greater margins involvement (0.0007), and biochemical (0.02), local (0.05) and metastatic (0.001) progression. Independent influential factors are: PSA > 20 ng/ml; T2bc and Gleason 7-10. From these values patients can be divided into 3 risk groups: a) Group I (0-1 unfavourable variables): risk of seminal vesicle involvement 7%; Group II (2 unfavourable variables): risk 47%; Group III (3 unfavourable variables): risk 61%. Progression-free survival: significantly lower than patients with pT2 (58 +/- 8% vs 66 +/- 6% at 5 years) (0.002), but similar to those with pT3ab (0.91). Seminal vesicle involvement is not an independent influential factor (Cox's multivariate study). Influential factors are PSA, Gleason and clinical stage. CONCLUSIONS: pT3c tumours are not an independently influential group in progression-free survival. Progression-free survival is lower than pT2 but similar to pT3ab. Their poor prognosis is dependent on association to negatively influential clinico-pathological factors.

Carcinoma de próstata.prostatectomía radical. Influencia del tratamiento hormonal. Neoadyuvante / Prostate carcinoma. Radical prostatectomy. Influence from hormone therapy. Neo-adjuvant

OBJETIVO: Valorar la influencia del tratamiento neoadyuvante hormonal, sobre el estadio patológico, márgenes y supervivencia libre de enfermedad, en pacientes con cáncer de próstata T1-T2 sometidos a prostatectomía radical. MATERIAL Y MÉTODOS: Se estudian 42 pacientes T1-T2 tratados de forma no aleatoria con bloqueo hormo-nal completo neoadyuvante y prostatectomía radical entre 1988-1998. Forman parte de 220 pacientes T1-T2 tratados con cirugía radical. El grupo se compara: a) con el resto de los pacientes (178) (Grupo I); y b) con un grupo escogido (54 pacientes) homogéneo en relación con las variables clínicas (Grupo II). La media de seguimiento: 35 meses, mediana: 32 meses. RESULTADOS: El grupo de pacientes con tratamiento neoadyuvante en relación con el Grupo I evidencia peor Gleason (p: 0,01), peor estadio clínico (p: 0,02), mayor proporción de pacientes de alto riesgo clínico (p: 0,03) y más alto PSA (aunque no estadísticamente diferente). No se objetivan diferencias en relación con estado patoló-gico o márgenes. En relación con el Grupo II (54 pacientes), no existen diferencias ni en las variables clínicas ni en las patológicas. En ningún caso hay diferencias en la supervivencia libre de progresión. CONCLUSIONES: La terapia neoadyuvante hormonal en pacientes T1-T2 de riesgo clínico alto, no supone mejo-ría en estadio patológico, márgenes o supervivencia libre en progresión (AU)

Prostatectomía radical en adenocarcinoma de próstata estadio pT3c / Radical prostatectomy in pT3C prostate adenocarcinoma

OBJETIVOS: Valorar la eficacia de la cirugía en pacientes pT3c; saber si constituye un factor de influencia independiente en la supervivencia y los factores clínicos de predicción diagnóstica. MATERIAL Y MÉTODOS: Se estudian 45 pacientes pT3c (TNM 1982) de una serie de 220 pacientes con cáncer de prós-tata T1-T2 sometidos a prostatectomía radical. Media y mediana de seguimiento: 42 y 36 meses respectivamente. RESULTADOS: El grupo pT3 constituye el 20 por ciento (45/220) de los pacientes. Tiene un PSA medio (25 ñ 2 ng/ml) significativamente más elevado (0,001), peor Gleason (0,0002) y estadio clínico (0,0003), mayor afectación de márgenes (0,0007), progresión bioquímica (0,02), local (0,05) y metastásica (0,001). Los factores de influencia independiente son: PSA > 20 ng/ml; T2bc y Gleason 7-10. Con ellos se forman tres grupos de riesgo: a) Grupo I (0-1 variable desfavorable): riesgo de afectación de vesícula seminal 7 por ciento; Grupo II (2 variables desfavorables): riesgo 47 por ciento; Grupo III (3 variables des-favorables): riesgo 61 por ciento. Supervivencia Libre de progresión: es significativamente menor que la de los pT2 (58 ñ 8 por ciento vs 66 ñ 6 por ciento en 5 años) (0,002), pero similar a la de los pT3ab (0,91).La afectación de vesícula seminal no es un factor de influencia independiente (estudio multivariado de Cox). Los factores influyentes son PSA, Gleason y estadio clínico. CONCLUSIONES: Los pT3c no son un grupo de influencia independiente en la supervivencia libre de progresión. Evidencian peor supervivencia libre de progresión que los pT2 e igual que los pT3ab. Su mal pronóstico depende de su asociación a factores clínico-patológicos de influencia negativa. (AU)

Expresión de p53 y ki67 en piezas de prostatectomía radical. relación con los datos clínico-patológicos y supervivencia / p53 and Ki67 expression in specimens from radical prostatectomy. Relationship to clinico-pathological and survival data

OBJETIVOS: El presente trabajo estudia en cáncer de próstata T1-T2: a) Si existe relación entre expresión de Ki67 y p53, y las variables clínico-patológicas. b) Si dicha expresión influye en la supervivencia libre de progresión. MATERIAL Y MÉTODOS: Se estudian 68 pacientes diagnosticados de cáncer de próstata T1-T2, sometidos a prostatectomía radical y estudio inmunohistoquímico de Ki67 y p53 en la pieza de prostatectomía, indicando en cada caso el porcentaje de células teñidas. El estudio se ha realizado: a) Comparando entre los grupos las medias del porcentaje de células teñidas.b) Agrupando a los pacientes de acuerdo con el porcentaje de expresión. En Ki67 se compara los que expresan 0-5 por ciento, con los que expresan > 5 por ciento. En p53, los que no expresan (0 por ciento) frente a los que expresan > 1 por ciento. Seguimiento medio: 20 meses; mediana: 16 meses. RESULTADOS: La expresión media de Ki67 es de 7,2 por ciento (57 por ciento de los casos > 5 por ciento). El 60 por ciento no sobreexpresa p53; la media es de 3,65 y sólo el 15 por ciento es superior a 5 por ciento. Hay correlación entre Ki67 y p53 (p: 0,002), pero no con PSA. La expresión de Ki67 se relaciona con peor estadio patológico (p: 0,07) y mayor progresión bioquímica (p: 0,07), e influye significativamente en la supervivencia libre de progresión en el estudio univariado (a tres años 76 por ciento versus 48 por ciento; p: 0,04) y en el multivariado (RR: 5,7; p: 0,005).La sobreexpresión de p53 no se relaciona con ninguna variable clínico-patológica, ni influye en la supervivencia libre de progresión. (AU)

Insulin-like growth factor-I reverts testicular atrophy in rats with advanced cirrhosis.

The pathogenesis of hypogonadism in cirrhosis is not completely understood. The levels of insulin-like growth factor-I (IGF-I), an anabolic factor with trophic actions on testes, are reduced in cirrhosis. This study was undertaken to evaluate whether rats with advanced cirrhosis develop hypogonadism and whether the administration of IGF-I exerts beneficial effects on testicular structure and function. Wistar rats with ascitic cirrhosis induced with CCl(4) were allocated into 2 groups (n = 10, each) to receive recombinant IGF-I (20 microg x kg(-1) x d(-1), subcutaneously) or vehicle for 3 weeks. Healthy rats receiving vehicle were used as the control group (n = 10). At baseline, both cirrhotic groups showed similar deterioration of liver function tests. Compared with controls, nontreated cirrhotic rats showed decreased serum levels of IGF-I (P <.05), reduced testicular size and weight (P <.001), and intense histopathological testicular abnormalities, including reduced tubular diameters (P <.001), loss of the germinal line (P <. 001), and diminutions in cellular proliferation, spermatogenesis (P <.001), and testicular transferrin expression (P <.001). In addition, low serum testosterone (P <.01) and high serum LH (P <.01) were present in untreated cirrhotic animals. Cirrhotic rats that received IGF-I showed full recovery of testicular size and weight and of all histopathological abnormalities (P <.001 to <.01 vs. nontreated cirrhotic rats; P = ns vs. controls). Serum levels of sex hormones tended to normalize. In conclusion, IGF-I deficiency may play a pathogenetic role in hypogonadism of cirrhosis. Low doses of IGF-I for a short period of time revert testicular atrophy and appear to improve hypogonadism in advanced experimental cirrhosis.

[p53 and Ki67 expression in specimens of radical prostatectomy. Relationship with clinico-pathologic data and survival]. / Expresión de p53 y Ki67 en piezas de prostatectomía radical. Relación con los datos clínico-patológicos y supervivencia.

OBJECTIVES: Analysis in T1-T2 prostate cancer of the following: a) Whether there is a relationship between Ki67 and p53 over-expression, and clinico-pathological variables. b) Whether that expression influences on progression free survival. MATERIAL AND METHODS: The study included 68 patients diagnosed with T1-T2 prostate cancer undergoing radical prostatectomy and immunohistochemical testing of Ki67 and p53 in the prostatectomy specimen, indicating in each case the percentage of stained cells. The study was carried out by: a) Comparison of means between percentage groups of stained cells. b) Grouping patients according to expression percentage. In Ki67, a comparison is made between those expressing 0-5% vs > 5%. In p53, those expressing (0%) vs > 1%. Mean follow-up: 20 months; median: 16 months. RESULTS: Mean expression of Ki67 is 7.2% (57% cases > 5%). 60% do not over-express p53; mean 3.65; only 15% is higher than 5%. There is a correlation between Ki67 and p53 (p: 0.002), but not to PSA. Ki67 expression is related with a poorer pathological stage (p: 0.07) and greater biochemical progression (p: 0.07), and it has a significant influence on progression free survival in both the univariate (at three years 76% vs 48%; p: 0.04) and the multivariate studies (RR: 5.7; p: 0.005). Over-expression of p53 is not related to any clinico-pathological variable, and does not influence progression free survival.

[Chromophobe carcinoma of the kidney]. / Carcinoma cromófobo de riñón.

INTRODUCTION: Chromophobe renal cell carcinoma, described in 1985 is a type of renal carcinoma which is relatively uncommon (5%). Although the majority of studies published suggest a more favourable prognosis, conclusive evidence does not exist. In this study we present the clinical and ultrastructural characteristics and particularly the prognoses of 15 patients taken from a group of 230, all of whom had been diagnosed as suffering from renal carcinoma and for which they had received surgical treatment. MATERIAL AND METHODS: 230 kidneys were analysed between June 1990 and December 1997. The tissue was fixed and dyed with H-E, Hale's acid iron colloid and PAS. Two models were defined, typical and eosinophil. In 8 cases the tissue was processed in order to quantify the DNA using flow cytometry. RESULTS: Of the 230 kidneys analyzed, 15 were identified as being compatible with a diagnosis of chromophobe carcinoma, representing 6.5% of the group studied whilst 73% corresponded to the typical model. The average follow-up period for the 15 patients studied was of three and a half years. Upon completion of the study, 14 out of the 15 patients were still alive and the remaining one had died from causes unrelated to his illness. The average period of survival was 43 months. The tumors had an average diameter of 7.9 cm. The nuclear grade was GII on 10 occasions (seven T2, one T3a and two T3b) and GIII on 5 (four T2, one T3a and two T3b). The study of flow cytometry showed four cases of multiploids two of aneuploids one tetraploid and one diploid. CONCLUSIONS: Chromophobe renal cell carcinoma is a relatively uncommon (6.5%) type of renal carcinoma. The typical ultrastructural type is the most common (73%). The highly favourable pathologic stage (p2 73%) and the significantly low nuclear grade (66% GII) suggest that this is a tumour with a rather better prognosis, as is shown by an increased period of survival.

[Radical prostatectomy in clinically localized prostatic adenocarcinoma. Factors influencing biochemical progression free survival]. / Prostatectomía radical en adenocarcinoma de próstata clínicamente localizado. Factores influyentes en la supervivencia libre de progresión bioquímica.

MATERIAL AND METHOD: Study of biochemical progression (PSA > 0.5 ng/ml) and biochemical progression-free survival in 160 patients diagnosed with clinically localized prostate adenocarcinoma who underwent radical prostatectomy at the University Clinic in Navarra between 1988-1997. RESULTS: At the end of the study, 120 patients (75%) are alive and free of progression, 33 (20%) are alive and in progression, 3 (1.9%) died of cancer, and 4 (2.5%) died for other causes. Biochemical progression occurred in 43/160 (27%) patients. Progression is related to previous PSA, both in absolute terms and divided into greater or smaller than 15 ng/ml; to Gleason grade greater or smaller than 7 or divided into 2-4, 5-7, 8-10; to pathological stage and to urethro-vesical junction stenosis. Biochemical progression-free survival (BPFS) in the univariate study is related to PSA (the ideal prognostic cut-off value being 15 ng/ml); to Gleason, specially when divided into 2-4, 5-7, 8-10; to the pathological stage and to margins. The multivariate study evidences that the single most influential factors are PSA (divided as greater or smaller than 15 ng/ml), Gleason grade (divided into: 2-4, 5-7, 8-10) and margins involvement. There are 3 highly reliable risk groups based on PSA, Gleason and clinical stage. When these are introduced as variables in the multivariate study, they appear as the strongest predictive variables. CONCLUSIONS: The influential factors on progression-free survival are PSA (15 ng/ml being the best prognostic cut-off value), Gleason grade (divided into 2-4, 5-7, 8-10) and margins' positivity, which are the single most significant pathological factor ahead of clinical stage. Serum PSA, clinical stage and Gleason grade allow to define three reliable risk groups.

[Radical prostatectomy in clinically localized prostatic adenocarcinoma. Study of patients with positive margins and their impact on survival free from biochemical progression]. / Prostatectomía radical en adenocarcinoma de próstata clínicamente localizado. Estudio de los pacientes con márgenes positivos y su influencia en la supervivencia libre de progresión bioquímica.

OBJECTIVES: Margins involvement in T1-T2 patients undergoing radical prostatectomy is a negative prognostic factor. We aimed to: a) Study the clinical and pathological features of patients with surgical margins involvement; b) Elucidate the influence of margins involvement on the progression-free survival. MATERIAL AND METHOD: The study included the group with "positive margins" out of a series of 160 patients with localised prostate adenocarcinoma who underwent radical prostatectomy at the Clínica Universitaria de Navarra between 1988-1997. statistics used: Fisher's or Pearson's test for qualitative variables. Kaplan-Meyer, Log-rank and Cox's multivariate tests for the survival study. RESULTS: The group accounts for 28% (45/158) of all patients undergoing radical prostatectomy. Mean PSA (22 +/- 14 ng/ml) is similar to the remaining group although there is greater significant rates of PSA > 15 ng/ml (p: 0.006), worse Gleason (p: 0.01), higher proportion of T2bc (p: 0.003) and node involvement (0.001). Progression-free survival (BPFS) is significantly lower in this group (32 +/- 12% vs 61 +/- 6% at 5 years). Margins are the single factor with higher influence (RR:5) in the multivariate study. Influence is clear in patients with Gleason < 5 (0% vs 87%) and PSA < 30 ng/ml (33 +/- 14 vs 70 +/- 7%), but has no influence on BPFS of patients with PSA > 30 ng/ml or Gleason 5-10. CONCLUSIONS: Positive margins in patients undergoing radical prostatectomy is associated to higher PSA, worse Gleason and higher stage. They are the most significant independent risk factor (except for PSA > 30 ng/ml) for biochemical progression-free survival as evidenced in the multivariate study, although it is likely this influence is diluted in patients with PSA > 30 ng/ml and/or Gleason 5-10.

Effect of digital rectal examination and flexible cystoscopy on free and total prostate-specific antigen, and the percentage of free prostate-specific antigen. Differences between two PSA assays.

OBJECTIVE: To determine the effect of prostate manipulations on free PSA, total PSA and the percentage of free PSA using an equimolar and nonequimolar PSA assays. METHOD: A total of 67 men were studied. Blood samples were obtained before and 45-60 min after two different prostatic manipulations: DRE from 45 patients and flexible cystoscopy from 22 patients. Total PSA (t-PSA) was assayed with a non equimolar method using the Cobas Core PSA kit from Roche (Cobas Core-PSA) and an equimolar method using the Immulite 3rd-generation PSA kit from DPC (Immulite-PSA). Free PSA (f-PSA) was quantified with an Immulite free PSA kit. We obtained two f-PSA/t-PSA ratios dividing the f-PSA by both t-PSA (Cobas Core-PSA) and t-PSA (Immulite-PSA). RESULTS: The Cobas Core-PSA yielded higher values than Immulite-PSA and the baseline percentages of free PSA were different depending on the method used. Both t-PSA values were increased after DRE and flexible cystoscopy from the baseline although the increase of Cobas Core-PSA was much higher than Immulite-PSA. Also the f-PSA was increased after the two manipulations. The f-PSA/t-PSA ratio (Cobas Core-PSA) remains at the baseline whereas the f-PSA/t-PSA ratio (Immulite-PSA) had an important increase from the baseline. CONCLUSION: The effect of DRE and flexible cystoscopy is different depending on the PSA assay used. The data from studies which are carried out in relation with the molecular forms of the PSA are not interchangeable if they are performed with different PSA methods (equimolar and nonequimolar). The serum samples should precede any prostate manipulation in all investigations related to PSA molecular forms.

Surgical management of retroperitoneal tumors with vena caval thrombus in the inferior cava using cardiopulmonary bypass, arrested circulation and profound hypothermia.

OBJECTIVE: It was our aim to review our surgical experience with retroperitoneal tumors extending to the vena cava by using cardiopulmonary bypass, deep hypothermia and circulatory arrest. METHOD: We performed this procedure in 15 patients. The ages ranged between 16 and 70 years. The primary malignancies were renal cell carcinoma (n = 13), Wilms' tumor (n = 1) and paratesticular rhabdomyosarcoma (n = 1). RESULTS: There were no operative deaths. One patient died on the fourth postoperative day because of pulmonary embolization. The most common postoperative complications were: 1 patient required surgical reexploration because of hemorrhage, there was transitory renal failure in 3 patients, 1 patient developed a postoperative reactive psychosis and 1 patient developed a subclinical pericarditis. CONCLUSION: We believe that the resection of retroperitoneal malignancies with venous tumor thrombus extension offers, in selected patients, the only chance of reasonable long-term survival. The application of a cardiopulmonary bypass and hypothermia in high level vena cava thrombi is an important advance that has improved the safety and technical efficacy of a difficult surgical undertaking.

Incidentally detected renal cell carcinoma.

OBJECTIVES: To determine the incidence of renal cell carcinoma (RCC) detected incidentally and to compare the survival of these patients with that of patients presenting with suspected RCC. PATIENTS AND METHODS: In a retrospective study, 157 patients surgically treated for RCC from 1979 to 1993 were grouped according to whether the tumour was found incidentally (n = 55) or whether the renal tumour was suspected (n = 102). The groups were compared for tumour grade, stage and size, patient age, sex and survival using univariate and multivariate analyses. RESULTS: There were significant differences between the groups in the number of patients with T2 (P < 0.001), T3a (P < 0.05), T3b (P < 0.01), T4 (P < 0.05) and M1 (P < 0.05) stages of disease. There was also a significantly greater proportion of patients with grade 1-2 tumours (P < 0.05) in those diagnosed incidentally. The accumulated overall survival rate was 64% at 5 years, 50% in the group with suspected RCC and 86% in those with tumours discovered incidentally over the same period. There were significant differences (P < 0.001) in the distribution of survival in the two groups. CONCLUSION: The patients with incidentally discovered RCC had a prognostically more favourable tumour stage, grade and size. Pathological stage and lymph node metastases influenced the difference in survival between the groups. As there was no difference in survival with tumour stage (T1-2), we consider that grade, size and particularly pathological stage determine the better prognosis.