Personalised indocyanine-guided lymphadenectomy for prostate cancer: a randomised clinical trial.

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.

Indocyanine green guidance improves the efficiency of extended pelvic lymph node dissection during laparoscopic radical prostatectomy.

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.

The role of cystectomy in elderly patients - a multicentre analysis.

INTRODUCTION: Life expectancy in developed countries is continuously increasing. Hence elderly patients are becoming more common in our clinical practice. Currently, one of the greatest challenges of medicine is balancing the life expectancy of elderly patients against aggressive treatments that carry significant risks. OBJECTIVE: To outline the complications and survival in surgical patients 80 years and over undergoing radical cystectomy for bladder cancer. PATIENTS AND METHODS: A review of a radical cystectomy in elderly recorded in four different institutional prospective databases during the period between 1991 and 2014. Clinical and pathologic features, complications and survival were evaluated. RESULTS: A total of 111 patients were available. Median (range) age 82.2 (80-89) years. Seventeen women and 94 men. Regarding the ASA score, 6 patients were ASA I, 47 patients were ASA II, 49 patients ASA III and 9 ASA IV. Prior to surgery, 48 patients had hydronephrosis. The median (range) creatinine series was 1.1 (0.71-11.1) ng/dL. In 88 cases an ileal conduit was performed, 17 a cutaneous ureterostomy diversion, 5 neobladders and 1 ureterosigmoidostomy case. The median (range) operative time was 230 (120-420) min and a total of 97 patients required blood transfusion. The median (range) hospital stay was 14 (7-126) days. The early and late complication rates were 50.4% and 32%, respectively. A total of 14 patients (12.6%) required surgical reintervention. Eight patients (7.2%) died in the immediate postoperative period. The readmission rate of the series was 27.2%. The mean follow-up of the series was 18 (0.27-134.73) months. During this period 66 patients died, 52 of them due to the tumor. Twelve month tumour progression free survival was 83.9% for ≤pT1, 70.2% for pT2 and 36% for ≥pT3, respectively. Twelve month cancer specific survival was 85.6% for ≤pT1, 75.1% for pT2 and 42.5% for ≥pT3, respectively. CONCLUSION: Radical cystectomy in elderly population is an aggressive surgical treatment with a significant complication rate, hospital readmission and perioperative mortality rate. Careful selection of patients is essential in order to minimize the complications of this surgery and balance benefits against risks in the elderly population. Tumour progression and cancer specific survival are poor for patients with ≥pT3 disease. Alternatives such as tri-modality therapy need to be considered within a multi-disciplinary approach. More data is required to determine which sub-groups of elderly patients would benefit from a complication, survival and quality of life perspective.

Importance of previous transurethral resection of the prostate before eerpe.short-term functional outcomes in a single surgeon series.

OBJECTIVES: Laparoscopic Radical Prostatectomy (LRP) is technically a very demanding procedure and potentially even more challenging in patients with previous transurethral resection (TURP). This study evaluates the impact of previous TURP on the short-term functional outcome of patients undergoing extraperitoneal LRP. METHODS: Retrospective analysis of a prospectively collected database, comprising a single-surgeon cohort of 155 consecutive LRP cases, 19 of which had previous history of TURP. Demographics, clinical and functional outcomes were evaluated and compared among patients with and without previous TURP. Multivariate analysis was performed to identify potential variables independently associated with continence outcomes. Incontinence was defined as the need of more than 1 pad/day. Potency was defined as the ability for sexual intercourse with or without the use of phosphodiesterase inhibitors. RESULTS: Demographic and clinical variables were comparable among the two study groups. Neurovascular bundle preservation was possible in 26% and 37% of patients with and without previous TURP, respectively. No major complications were recorded and the incidence of minor complications was comparable. Overall continence rate at 3 months was 82,58%, for the entire cohort. Subset analysis demonstrated a 3-month continence rate of 73.7% vs. 83.8% (p>0.05) in patients with and without TURP, respectively. Multivariate analysis demonstrated age, BMI and ASA were variables independently associated with continence outcomes. In the cohort of patients with previous TURP, 2 out of 7 undergoing preservation recovered erections, with a mean follow up of 15.5 months, comparable to the 30% achieved in patients without TURP and nerve sparing procedure. CONCLUSIONS: Laparoscopic Radical Prostatectomy in patients with previous TURP is feasible, with complication rates and short-term functional outcomes comparable to those in patients without previous resection.

Relevancia de la resección transuretral de próstata en los resultados funcionales de la prostatectomía radical laparoscópica / Importance of previous transurethral resection of the prostate before eerpe. short-term functional outcomes in a single surgeon series

OBJETIVO: La dificultad del tratamiento quirúrgico del Cáncer de próstata (caP) se acentúa en los pacientes con antecedentes de resección transuretral de próstata (RTU). En este estudio valoraremos la influencia de la RTU en los resultados funcionales a corto plazo de la prostatectomía radical laparoscópica extraperitoneal. MÉTODO: Revisión retrospectiva de una base de datos de cumplimentación prospectiva de una serie de pacientes intervenidos por un solo cirujano de manera consecutiva. Se compararon las características demográficas, clínicas y patológicas de los pacientes con y sin RTU previa, para posteriormente realizar un estudio multivariante mediante regresión logística para comprobar qué variables se asociaban de manera independiente y significativa a la incontinencia según el criterio (>1 compresa/día). Se consideró potentes a aquellos pacientes capaces de penetrar con o sin la ayuda de inhibidores de la 5 fosfodiesterasa. Se dispuso de la evaluación funcional de 155 pacientes, 19 de los cuales tenían antecedentes de RTU previa. RESULTADOS: Los subgrupos no diferían en las variables relevantes para el estudio. La conservación de haces neurovasculares se realizó en un 37% de los pacientes sin RTU previa y en un 26% del grupo contrario. No se objetivaron complicaciones mayores, la frecuencia de complicaciones menores no difería. La tasa de continencia de la serie global, evaluada en los 3 primeros meses, era del 82,58%. En el subgrupo de pacientes sin antecedentes de RTU previa era del 83,8% mientras que en el subgrupo de pacientes con RTU previa era del 73,7%, p>0,05. En el análisis multivariante, se asociaron de manera independiente y significativa a la continencia la edad, el IMC y el ASA. Tampoco se observaron diferencias significativas en la proporción de pacientes que recuperaron la erección en uno y otro grupo (28 vs 30%). CONCLUSIONES: Los resultados funcionales a corto plazo son aceptables y comparables a los de los pacientes sin resección previa (AU)

OBJECTIVES: Laparoscopic Radical Prostatectomy (LRP) is technically a very demanding procedure and potentially even more challenging in patients with previous trans-urethral resection (TURP). This study evaluates the impact of previous TURP on the short-term functional outcome of patients undergoing extraperitoneal LRP. METHODS: Retrospective analysis of a prospectively collected database, comprising a single-surgeon cohort of 155 consecutive LRP cases, 19 of which had previous history of TURP. Demographics, clinical and functional outcomes were evaluated and compared among patients with and without previous TURP. Multivariate analysis was performed to identify potential variables independently associated with continence outcomes. Incontinence was defined as the need of more than 1 pad/day. Potency was defined as the ability for sexual intercourse with or without the use of phosphodiesterase inhibitors. RESULTS: Demographic and clinical variables were comparable among the two study groups. Neurovascular bundle preservation was possible in 26% and 37% of patients with and without previous TURP, respectively. No major complications were recorded and the incidence of minor complications was comparable. Overall continence rate at 3 months was 82,58%, for the entire cohort. Subset analysis demonstrated a 3-month continence rate of 73.7% vs. 83.8% (p>0.05) in patients with and without TURP, respectively. Multivariate analysis demonstrated age, BMI and ASA were variables independently associated with continence outcomes. In the cohort of patients with previous TURP, 2 out of 7 undergoing preservation recovered erections, with a mean follow up of 15.5 months, comparable to the 30% achieved in patients without TURP and nerve sparing procedure. CONCLUSIONS: Laparoscopic Radical Prostatectomy in patients with previous TURP is feasible, with complication rates and short-term functional outcomes comparable to those in patients without previous resection (AU)

[Comparative study between analgesic efficacy and safety of meperidine compared with lidocaine periprostatic infiltration in transrectal ultrasound guided prostate biopsy]. / Estudio comparativo entre la eficacia analgésica y seguridad de la meperidina intravenosa frente a la infiltración periprostática con lidocaína en biopsias transrectales de próstata.

OBJECTIVES: To assess the efficacy of intravenous analgesia with meperidine compared to periprostatic plexus infiltration with lidocaine, and safety of periprostatic local anesthesia. MATERIALS AND METHODS: A prospective randomized study with 100 patients undergoing first or second prostate biopsy. We distribute patients in two groups, group A (50 patients) which was administered 50 mg of intravenous meperidine and group B (50 patients) receiving 5 mL of lidocaine 2% in the angle between prostate and seminal vesicles. Pain was assessed by Visual Analog Scale (VAS) and a questionnaire about the emotional impact. Procedure safety was obtained by telephone questionnaire about prostate biopsy complications. The statistical analysis used was chi square test, Student's t test and Kruskal-Wallis no parametric test. RESULTS: Median age was 66 years (47-80) and both groups were homogeneous with regard to: PSA, prostate volume, core's number and educational level without significant differences. 74 patients (74%) had their first biopsy and 26 (26%) had their second one. The average number of core biopsy was 10,9 +/- 2, and VAS mean score for group A was 3,6 +/- 1,8 versus 3,2 +/- 2 Group B without significant differences (p>0,05). We found significant differences (p<0,05) between transducer introduction (3,9 +/- 1,9 group A/B group 4,3 +/- 2,2) and core biopsy (3,6 +/- 1,8 group A/B group 3,2 +/- 2,2). There were no differences between the data obtained with emotional impact test, age and educational level comparing to pain caused by prostate biopsy. Regard to the number of cores obtained there were no differences (p>0,05). Complications appeared in 12 patients (12%), 5 in the group of meperidine compared with 7 in the lidocaine without differences between them. CONCLUSION: Periprostatic plexus blocked with lidocaine does not offer advantages respect to meperidine, despite the fact that this is a safe method that does not increase the number of complications. Placing transrectal transducer causes more pain than biopsy cores.

Estudio comparativo entre la eficacia analgésica y seguridad de la meperidina intravenosa frente a la infiltración periprostática con lidocaína en biopsias transrectales de próstata / Comparative study between analgesic efficacy and safety of meperidine compared with lidocaine periprostatic infiltration in transrectal ultrasound guided prostate biopsy

Objetivo: Evaluar la eficacia de la analgesia intravenosa con meperidina frente a la infiltración del plexo periprostático con lidocaína, y seguridad de la anestesia local periprostática. Material y métodos: Estudio prospectivo aleatorizado con 100 pacientes sometidos a primera o segunda biopsia de próstata. Distribuimos a los pacientes en dos grupos; grupo A (50 pacientes) al que se le administra 50 mg de meperidina intravenosa y grupo B (50 pacientes) que reciben 5 mL de lidocaína al 2% en el ángulo prostatoseminal. El dolor fue evaluado mediante la Escala Analógico Visual (VAS) y un cuestionario a cerca del impacto emocional de la prueba. La seguridad del procedimiento se obtuvo mediante cuestionario telefónico sobre las complicaciones aparecidas tras la biopsia. Para el análisis estadístico se uso el test de chi cuadrado, la t de Student y test no paramétrico de Kruskal-Wallis. Resultados: La mediana de edad fue 66 años (47-80) siendo ambos grupos homogéneos respecto a: PSA, volumen prostático, número de cilindros y nivel de estudios, sin diferencias significativas. Se trató de una primera biopsia en 74 pacientes (74%) y 26 (26%) de una segunda. El número medio de cilindros fue de 10,9±2. La puntuación media del VAS para el grupo A fue 3,6±1,8 frente a 3,2±2 del grupo B sin diferencias significativas (p>0,05). Si comparamos el dolor con la introducción del transductor (grupo A 3,9±1,9 / grupo B 4,3±2,2) frente a la toma de cilindro (grupo A 3,6±1,8/grupo B 3,2±22) sí encontramos diferencias significativas (p<0,05). No se observan diferencias ente los datos obtenidos con el test de impacto emocional, la edad y el nivel de estudios frente al dolor producido por la prueba. Respecto al número de cilindros obtenidos tampoco existen diferencias (p>0,05). Aparecieron complicaciones en 12 pacientes (12%); 5 en el grupo de meperidina frente a 7 en el de lidocaína sin observar diferencias entre ambos. Conclusión: El bloqueo del plexo periprostático con lidocaína no ofrece ventajas analgésicas respecto a la meperidina, a pesar de que se trata de un método seguro que no aumenta el número de complicaciones. El paso del transductor transrrectal produce más dolor que la propia toma de los cilindros (AU)

Objectives: To assess the efficacy of intravenous analgesia with meperidine compared to periprostatic plexus infiltration with lidocaine, and safety of periprostatic local anesthesia. Materials and methods: A prospective randomized study with 100 patients undergoing first or second prostate biopsy. We distribute patients in two groups, group A (50 patients) which was administered 50 mg of intravenous meperidine and group B (50 patients) receiving 5 mL of lidocaine 2% in the angle between prostate and seminal vesicles. Pain was assessed by Visual Analog Scale (VAS) and a questionnaire about the emotional impact. Procedure safety was obtained by telephone questionnaire about prostate biopsy complications. The statistical analysis used was chi square test, Student’s t test and Kruskal-Wallis no parametric test. Results: Median age was 66 years (47-80) and both groups were homogeneous with regard to: PSA, prostate volume, core’s number and educational level without significant differences. 74 patients (74%) had their first biopsy and 26 (26%) had their second one. The average number of core biopsy was 10,9±2, and VAS mean score for group A was 3,6±1,8 versus 3,2±2 Group B without significant differences (p>0,05). We found significant differences (p<0,05) between transducer introduction (3,9±1,9 group A/B group 4,3±2,2) and core biopsy (3,6±1,8 group A/B group 3,2±2,2). There were no differences between the data obtained with emotional impact test, age and educational level comparing to pain caused by prostate biopsy. Regard to the number of cores obtained there were no differences (p>0,05). Complications appeared in 12 patients (12%), 5 in the group of meperidine compared with 7 in the lidocaine without differences between them. Conclusion: Periprostatic plexus blocked with lidocaine does not offer advantages respect to meperidine, despite the fact that this is a safe method that does not increase the number of complications. Placing transrectal transducer causes more pain than biopsy cores (AU)