Assessment of a novel smartglass-based point-of-care fusion approach for mixed reality-assisted targeted prostate biopsy: A pilot proof-of-concept study.

Purpose: While several biopsy techniques and platforms for magnetic resonance imaging (MRI)-guided targeted biopsy of the prostate have been established, none of them has proven definite superiority. Augmented and virtual reality (mixed reality) smartglasses have emerged as an innovative technology to support image-guidance and optimize accuracy during medical interventions. We aimed to investigate the benefits of smartglasses for MRI-guided mixed reality-assisted cognitive targeted biopsy of the prostate. Methods: For prospectively collected patients with suspect prostate PIRADS lesions, multiparametric MRI was uploaded to a smartglass (Microsoft® Hololens I), and smartglass-assisted targeted biopsy (SMART TB) of the prostate was executed by generation of a cognitive fusion technology at the point-of-care. Detection rates of prostate cancer (PCA) were compared between SMART TB and 12-core systematic biopsy. Assessment of SMART-TB was executed by the two performing surgeons based on 10 domains on a 10-point scale ranging from bad (1) to excellent (10). Results: SMART TB and systematic biopsy of the prostate were performed for 10 patients with a total of 17 suspect PIRADS lesions (PIRADS 3, n = 6; PIRADS 4, n = 6; PIRADS 5, n = 5). PCA detection rate per core was significant (p < 0.05) higher for SMART TB (47%) than for systematic biopsy (19%). Likelihood for PCA according to each core of a PIRADS lesion (17%, PIRADS 3; 58%, PIRADS 4; 67%, PIRADS 5) demonstrated convenient accuracy. Feasibility scores for SMART TB were high for practicality (10), multitasking (10), execution speed (9), comfort (8), improvement of surgery (8) and image quality (8), medium for physical stress (6) and device handling (6) and low for device weight (5) and battery autonomy (4). Conclusion: SMART TB has the potential to increase accuracy for PCA detection and might enhance cognitive MRI-guided targeted prostate biopsy in the future.

First completely robot-assisted retroperitoneal nephroureterectomy with bladder cuff: a step-by-step technique.

INTRODUCTION: While various surgical techniques have been reported for open and minimally invasive treatment of upper tract urothelial cancer (UTUC), the procedure of robot-assisted nephroureterectomy (NU) with bladder cuff has never been reported using only retroperitoneum without entering abdominal cavity. We developed a novel port placement and technique allowing to perform robot-assisted NU by a unique retroperitoneal approach. METHODS: Between February and June 2021 patients with history of UTUC were treated by robot-assisted NU completely restricted to retroperitoneal space using a singular trocar placement and a two-step docking without relocation of the surgical robot. Patient characteristics, perioperative outcomes and short-term follow-up were prospectively analyzed. RESULTS: The analysis included five patients [median age: 73 years; BMI: 27.2 kg/m2; Charlson comorbidity index 5]. All five patients had UTUC with a mean tumor size of 3.02 cm (range 0.9-6.0). UTUC was localized to distal ureter in two and to kidney in three cases. No positive surgical margins were noted for all patients with UTUC [1 low-grade and 4 high-grade]. Retroperitoneal lymphadenectomy in three patients did not reveal positive nodes. No intraoperative adverse events exceeding EAUiaiC classification ≥ 2 were observed, while median EBL was 150 ml (IQR 100-250). No patient experienced postoperative complications exceeding Clavien-Dindo classification ≥ 3a. Median hospital stay was 5.4d without any 30-d readmission. CONCLUSION: We demonstrate safety and feasibility of the first entire robot-assisted retroperitoneal nephroureterectomy (RRNU) with bladder cuff. This surgical technique is easily reproducible, while surgical outcomes are similar to other established techniques.

Heart rate variability for rapid risk stratification of emergency patients with malignant disease.

INTRODUCTION: Neoplasms are the second most common diseases in western countries. Many patients with malignant diseases repeatedly present themselves in the emergency department (ED). Due to limited capacities, appropriate risk stratification strategies for cancer patients have to be developed. This study assesses if deceleration capacity (DC) of heart rate as a parameter of heart rate variability predicts mortality in emergency patients with malignant diseases. METHODS: Prospectively, 140 adults with different entities of malignant diseases who presented in the medical ED were included. Primary and secondary endpoints were intrahospital mortality and mortality within 180 days, respectively. We calculated DC from short-term ECG readings of the surveillance monitors. Additionally, the Modified Early Warning Score (MEWS) and laboratory parameters such as white blood cells (WBC), lactate dehydrogenase, serum hemoglobin, and serum creatinine were determined. RESULTS: The median age of the patients was 65 ± 14 years. 19.3% of the patients died within the hospital stay and 57.9% died within 180 days. DC and WBC were independent predictors of intrahospital death reaching a hazard ratio (HR) of 0.79 (95% confidence interval (CI) 0.63-0.993, p = 0.043) and of 1.00 (95% CI 1.00-1.00, p = 0.003), respectively. DC and serum creatinine independently predicted death within 180 days (HR 0.90, 95% CI 0.82-0.98, p = 0.023 and HR 1.41, 95% CI 1.05-1.90, p = 0.018, respectively). CONCLUSION: Deceleration capacity of heart rate is suitable for rapid risk assessment of emergency patients with malignant diseases.

Long-term survival of patients aged 80 years or older treated with radical prostatectomy for prostate cancer.

BACKGROUND: Radical prostatectomy (RP) is the gold standard for clinically localized prostate cancer (PCa) patients with life expectancy (LE) of at least 10 years. We examined long-term survival of men aged 80 years or older treated with RP and we attempted to identify criteria based on age and comorbidities that could predict survival of at least 10 years after RP, to identify those that might be considered for RP. PATIENTS AND METHODS: In Surveillance Epidemiology and End Results (SEER)-Medicare-linked database, we identified 234 octo- and nonagenarians with clinical T1, T2 or T3 PCa treated with RP between 1991 and 2009. Kaplan-Meier analyses examined 10-year survival patterns. Multivariable Cox regression analyses focused on the combined effect of age and/or Charlson Comorbidity Index (CCI) after adjusting for different confounders. RESULTS: The 10-year overall survival (OS) and cancer specific mortality (CSM) rates in the overall population were 51 and 9.9%. In individuals aged 80-81 years old, the 10-year OS was 62.4 vs. 39.6% in older patients (p = 0.001). Moreover, combination of age 80-81 with CCI = 0 yielded 10-year OS of 67.9 vs. 28.5% in older and sicker patients (p < 0.001). Age 80-81, absence of comorbidities and the combination of age 80-81 with CCI = 0, represented independent predictors of lower overall mortality (all p ≤ 0.01). CONCLUSIONS: Two out of three individuals selected for RP aged 80-81 years and without comorbidities, fulfill the criterion of LE of 10 years or more. Therefore, elderly PCa individuals can be suitable for surgical management, if appropriately selected, based on LE criterion.

Mortality, morbidity and healthcare expenditures after local tumour ablation or partial nephrectomy for T1A kidney cancer.

BACKGROUND: Local tumour ablation (LTA) may yield better perioperative outcomes than partial nephrectomy (PN), however the impact of each treatment on perioperative mortality and health care expenditures is unknown. The aim of the study was to compare mortality, morbidity and health care expenditures between LTA and PN. PATIENTS AND METHODS: A population-based assessment of 2471 patients with cT1a kidney cancer treated with either LTA or PN, between 2000 and 2009, in the SEER-Medicare database was performed. After propensity score matching, 30-day mortality, overall and specific complication rates, length of stay, readmission rates and health care expenditures according to LTA or PN were estimated. Multivariable logistic and linear models addressed the effect of each specific LTA approach on overall complication rates, length of stay, readmission rates and health care expenditures. RESULTS: The 30-day mortality was <2% after either LTA or PN (OR 2.27, p = 0.2). The overall complication rate was 21% after LTA and 40% after PN (OR 0.38, p < 0.001). Blood transfusions, infection/sepsis, wound infections, respiratory complications, gastrointestinal complications, acute kidney injury, and accidental puncture or laceration/foreign body left during procedure rates resulted lower after LTA relative to PN (all p < 0.05). Similarly, length of stay and health care expenditures resulted lower after LTA relative to PN (all p < 0.05). Conversely, readmission rate was not significantly different in LTA relative to PN (p = 0.1). CONCLUSIONS: Despite similar perioperative mortality, LTA is associated with lower complications rate, shorter length of stay and lower health care expenditure relative to PN.

[Infra- and supradiaphragmatic urethral injuries. Acute treatment]. / Infra- und supradiaphragmale Urethraverletzungen. Akute Therapie.

BACKGROUND: Urethral injuries are often caused by pelvic fractures or blunt trauma. Drainage of the urinary bladder is the first step of therapy. RESULTS: Urethral injuries are often caused by pelvic fractures or blunt trauma. Drainage of the urinary bladder is the first step of therapy. Standard procedure is the insertion of a suprapubic stent in stable patients without concomitant open injuries in the pelvis area. Endoscopic realignment is useful in patients with pelvic fracture, vaginal, rectal, or bladder injury, who require open surgery. Delayed repair by stricture excision and open urethroplasty with end-to-end anastomosis is the standard procedure.

[Antibiotic stewardship (ABS). Definition, contents, necessity and practice on examples of current clinical-urological controversies]. / Antibiotic Stewardship (ABS). Definition, Inhalte, Notwendigkeit und Umsetzung an Beispielen aktueller klinisch-urologischer Kontroversen.

BACKGROUND: Infectious diseases caused by multi-resistant pathogens are increasing worldwide and are posing a challenge to German urology as well. Furthermore, there is a limited perspective of new antibiotic developments. One way out of this dilemma is a differentiated handling and use of antibiotics (antibiotic stewardship, ABS). AIM: The aim of this review is to identify key issues in modern urological antibiotic therapy, which can be considered as exemplary for the whole topic of ABS. This includes a review of the current data of the individual topics, including thought-provoking impulse for future clinical application and research. MATERIAL AND METHODS: The research group "infectious diseases" of GeSRU Academics identified the following central topics: excessive use of fluoroquinolones, diagnosis and treatment of urethritis and perioperative antibiotic prophylaxis. Subsequently, we performed a literature research in MEDLINE to uncover controversies and open questions of the individual topics within the meaning of ABS. RESULTS: The analysis of modern antibiotic therapy in urology shows numerous open questions in all quality dimensions of ABS: structural quality (e.g. through improved training of medical staff in the differentiated use of antibiotics), process quality (e.g. by improved adherence to existing infectiological guidelines, here in particular the perioperative prophylaxis and therapy of urethritis) and outcome (e.g. by detection of resistance rates and infection rates). DISCUSSION: The overarching and common goal is to avoid a post-antibiotic era. ABS programmes and a 10-point plan of the federal government are considered positive political developments in this area but do not release the individual urologist from a personal responsibility as part of his daily routine. A critical analysis of the topic "antibiotic treatment" is essential.

[Follow-up of urological tumor treatment]. / Nachsorge urologischer Tumorbehandlungen.

Follow-up of patients after curative treatment of urological cancer is an important component of the treatment of patients. The aim of the follow-up is to monitor the success of treatment and to identify local or distant recurrences early to be able to initiate further treatment. Investigations used for the monitoring should follow the principle "as much as necessary, as little as possible". The interval and method of follow-up investigations should be based on the risk of recurrence for the individual patient. In recent years follow-up schemes have been improved and, for example in testicular cancer, have been adjusted to the individual risk group. In contrast, for other tumors, such as metastatic bladder carcinoma, recommendations for follow-up do not seem to be individualized. This article therefore gives an overview on current recommendations and evidence for the follow-up of the most important genitourinary tumor types.

Adherence of the indication to European Association of Urology guideline recommended pelvic lymph node dissection at a high-volume center: Differences between open and robot-assisted radical prostatectomy.

PURPOSE: Contemporary adherence of the indication to European Association of Urology (EAU) guideline recommendation for pelvic lymph node dissection (PLND) at either open (ORP) or robot-assisted radical prostatectomy (RARP) at a high-volume center is unknown. To assess guideline recommended and observed PLND rates in a high-volume center cohort. METHODS: We relied on the Martini-Clinic database and focused on patients treated with either ORP or RARP, between 2010 and 2013. Actual performed PLND was compared to European Association of Urology (EAU) guideline recommendation defined by nomogram predicted risk of lymph node invasion >5%. Categorical and multivariable logistic regression analyses targeted two endpoints: 1) probability of guideline recommended PLND and 2) probability of no PLND, when not recommended by EAU guideline. RESULTS: Within 7868 PCa patients, adherence to EAU PLND guideline recommendation was 97.1% at ORP and 96.8% at RARP (p = 0.7). When PLND was not recommended, it was more frequently performed at RARP (71.6%) than at ORP (66.2%) (p = 0.002). Gleason score, PSA and number of positive biopsy cores were independent predictors for both either PLND when recommended, or no PLND when not recommended (all p < 0.05). Clinical tumor stage, age and surgical approach were also independent predictors for no PLND when not recommended (all p < 0.05). CONCLUSIONS: Adherence of the indication to EAU guideline recommended PLND is high at this high-volume center. Neither ORP nor RARP represent a barrier for PLND, when recommended. However, a high number of patients underwent PLND despite absence of guideline recommendation. Possible staging advantages and PLND related complications needs to be individually considered, especially, when LNI risk is low.

No impact of blood transfusion on oncological outcome after radical prostatectomy in patients with prostate cancer.

PURPOSE: To assess the association between blood loss, blood transfusion (BT) and biochemical recurrence (BCR)-free, metastasis-free and overall survival after radical prostatectomy (RP) in a large single-center cohort of patients. Perioperative BT at oncologic surgery has been reported to be a potential risk factor for cancer recurrence and survival in several cancer entities. Current studies addressing the relationship between BT, blood loss and BCR-free survival in prostate cancer patients are controversial and include only series with fairly small patient cohorts. MATERIALS AND METHODS: The data of 11,723 patients who underwent RP between 01/1992 and 08/2011 were analyzed. Cox regression analysis, including preoperative PSA level, pT stage, lymph node status, Gleason score, margin status, blood loss, transfusion rate (allogeneic or autologous), tested the relationship between blood loss, transfusion and BCR-free, metastasis-free and overall survival. Additionally, propensity score-matching analysis was performed to adjust differences in tumor characteristics. RESULTS: There was no statistically significant relationship between blood loss or BT and BCR-free, metastasis-free or overall survival. In multivariate analysis PSA level, pT stage, Gleason score, margin status and lymph node status were independent factors for a BCR (p < 0.0001). These results were identical after propensity score matching analysis, comparing patients with and without BT. CONCLUSIONS: This large-scale analysis revealed no correlation between blood loss, blood transfusion and oncological outcome in prostate cancer patients treated with RP. Therefore, the association between higher blood loss or transfusion rate and cancer recurrence as described in other surgical treated tumor entities seems to be irrelevant in prostate cancer patients.

Does HistoScanning™ predict positive results in prostate biopsy? A retrospective analysis of 1,188 sextants of the prostate.

PURPOSE: The role of HistoScanning™ (HS) in prostate biopsy is still indeterminate. Existing literature is sparse and controversial. To provide more evidence according to that important clinical topic, we analyzed institutional data from the Martini-Clinic, Prostate Cancer Center, Hamburg. METHODS: Patients who received prostate biopsy and who also received HS were included in the study cohort. A single examiner, blinded to pathological results, re-analyzed all HS data in accordance with sextants of the prostate. Each sextant was considered as an individual case. Corresponding results from biopsy and HS were analyzed. The area under the receiver-operating characteristic curve (AUC) for the prediction of a positive biopsy by HS was calculated. Furthermore, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were assessed according to different HS signal volume cutoffs (>0, >0.2 and >0.5 ml). RESULTS: Overall, 198 men were identified and 1,188 sextants were analyzed. The AUC to predict positive biopsy results by HS was 0.58. Sensitivity, specificity, PPV and NPV for HS to predict positive biopsy results per sextant, depending on different HS signal volume cutoffs (>0, >0.2 and >0.5 ml) were 84.1, 27.7, 29.5 and 82.9 %, 60.9, 50.6, 28.8 and 79.7 %, and 40.1, 73.3, 33.1 and 78.8 %, respectively. CONCLUSIONS: Positive HS signals do not accurately predict positive prostate biopsy results according to sextant analysis. We cannot recommend a variation of well-established random biopsy patterns or reduction of biopsy cores in accordance with HS signals at the moment.

Sunitinib malate for metastatic castration-resistant prostate cancer following docetaxel-based chemotherapy.

BACKGROUND: Systemic therapy options are limited for metastatic castration-resistant prostate cancer (CRPC) patients who progress following docetaxel (Taxotere). This phase II trial evaluated sunitinib malate in patients with progressing metastatic CRPC following prior docetaxel. PATIENTS AND METHODS: Patients with metastatic CRPC progressing following one to two chemotherapy regimens including docetaxel were included. The primary end point was progression-free survival (PFS) per radiographic and clinical evaluations. Oral sunitinib was administered 50 mg/day 4-weeks on followed by 2-weeks off per cycle up to a maximum of eight cycles or until clinical progression or intolerable toxicity. RESULTS: Thirty-six patients with a median age of 69.5 years were accrued. The median PFS was 19.4 weeks with a 12-week PFS of 75.8%. Four patients (12.1%) had a > or =50% prostate-specific antigen (PSA) decline and seven (21.2%) had a > or =30% PSA decline. Two of 18 patients (11.1%) with measurable disease demonstrated 30% declines by RECIST and eight (44.4%) displayed some shrinkage. A decline in pain score > or =2 points occurred in 13.6% of 22 assessable patients. Drug discontinuation due to toxic effects occurred in 52.8% of patients. CONCLUSION: Sunitinib malate demonstrated promising activity in metastatic CRPC progressing after prior docetaxel.

Phase II trial of docetaxel and oxaliplatin in patients with advanced gastric cancer and/or adenocarcinoma of the gastroesophageal junction.

BACKGROUND: Platinum-based chemotherapy is the standard treatment for advanced gastric cancer (GC). This trial explored the efficacy and tolerability of combined docetaxel (Taxotere) + oxaliplatin (DOCOX) in GC patients. PATIENTS AND METHODS: Patients with untreated stage IV GC or adenocarcinoma of the gastroesophageal junction (AGEJ) received docetaxel 60 mg/m(2) followed by oxaliplatin 130 mg/m(2) on day 1 of each 21-day cycle until progression or unacceptable toxicity. The primary end points were response rate (RR), toxicity, progression-free survival (PFS), and overall survival (OS). RESULTS: Baseline characteristics (N = 71): median age 59 years, 72% male, 51% esophagogastric junction cancer, and Eastern Cooperative Oncology Group performance status of zero, one, two were 42%, 51%, 7%, respectively. The median number of cycles was 6 (range, 1-19). Grades 3-4 toxic effects: neutropenia (70%); vomiting (17%); nausea (16%); dehydration, fatigue, or diarrhea (13%, each); and thrombocytopenia or febrile neutropenia (7%, each). Sixty-six patients completed >/=2 cycles. The RR was 36% with 25 partial response (PR) and no complete responses (CRs); stable disease (SD) was 49%. Clinical benefit rate (CBR = CR + PR + SD >/=6 months) was 40%; median PFS was 4.3 months, and OS was 8.5 months. CONCLUSIONS: DOCOX produced manageable toxicity in patients with advanced GC and AGEJ. The confirmed RR of 36%, CBR of 40%, and median survival of 8.5 months are encouraging and comparable to standard front-line regimens.

Gemcitabine plus CI-994 offers no advantage over gemcitabine alone in the treatment of patients with advanced pancreatic cancer: results of a phase II randomized, double-blind, placebo-controlled, multicenter study.

BACKGROUND: CI-994, an oral histone deacetylase inhibitor, has antineoplastic activity and synergism with gemcitabine preclinically. This randomized phase II trial explored whether CI-994 plus gemcitabine improves overall survival, objective response, duration of response, time to treatment failure and change in quality of life (QoL) or pain compared with gemcitabine alone. PATIENTS AND METHODS: A total of 174 patients received CG (CI-994 6 mg/m(2)/day days 1-21 plus gemcitabine 1000 mg/m(2) days 1, 8 and 15 each 28-day cycle) or PG (placebo plus gemcitabine 1000 mg/m(2) days 1, 8 and 15 of each 28-day cycle days 1-21). RESULTS: Median survival was 194 days (CG) versus 214 days (PG) (P = 0.908). The objective response rate with CG was 12% versus 14% with PG when investigator-assessed and 1% versus 6%, respectively, when assessed centrally. Time to treatment failure did not differ between the two arms (P = 0.304). QoL scores at 2 months were worse with CG than with PG. Pain response rates were similar between the two groups. There was an increased incidence of neutropenia and thrombocytopenia with CG. CONCLUSIONS: Adding CI-994 to gemcitabine in advanced pancreatic carcinoma does not improve overall survival, response rate or time to progression; CG produced decreased QoL and increased hematological toxicity and appears inferior to single-agent gemcitabine.

Pressure-modulated differential scanning calorimetry. An approach to the continuous, simultaneous determination of heat capacities and expansion coefficients.

A new method is described that permits the continuous and synchronous determination of heat capacity and expansibility data. We refer to it as pressure-modulated differential scanning calorimetry (PMDSC), as it involves a standard DSC temperature scan and superimposes on it a pressure modulation of preselected format. The power of the method is demonstrated using salt solutions for which the most accurate heat capacity and expansibility data exist in the literature. As the PMDSC measurements could reproduce the parameters with high accuracy and precision, we applied the method also to an aqueous suspension of multilamellar DSPC vesicles for which no expansibility data had been reported previously for the transition region. Excellent agreement was obtained between data from PMDSC and values from independent direct differential scanning densimetry measurements. The basic theoretical background of the method when using sawtooth-like pressure ramps is given under Supporting Information, and a complete statistical thermodynamic derivation of the general equations is presented in the accompanying paper.

Sequential versus concurrent paclitaxel and carboplatin for the treatment of advanced non-small cell lung cancer in elderly patients and patients with poor performance status: results of two Phase II, multicenter trials.

The primary objective of these trials was to determine the 1-year survival of advanced non-small cell lung cancer (ANSCLC) patients (> or =70 years with PS 0-2 or > or =18 years with PS 2) receiving sequential paclitaxel and carboplatin (P --> C) or concurrent P + C. The secondary objectives were assessment of toxicities and quality of life. A total of 121 patients with NSCLC were treated. P--> C patients received paclitaxel (80 mg/m(2)) weekly x 3, followed by 1 week of rest; these 4-week cycles were repeated until relapse. At relapse, patients received carboplatin (AUC = 5, IV) on Day 1 of each 3-week cycle until evidence of further progression or lack of improvement. P + C patients received paclitaxel (80 mg/m(2)) and carboplatin (AUC = 2), weekly x 3, followed by 1 week of rest, until relapse. Patients in both studies were premedicated prior to paclitaxel administration. Sequential P + C resulted in a median survival of 8.2 months (range: <1-18.8) and P + C patients had a median survival of 9.2 months (range: <1-22.0). In both groups (P--> C) and P + C), the 1-year survival was 31%. For patients treated sequentially, treatment-related AEs (TRAE, > or =Grade 3) included fatigue (7%), neuropathy (5%), and leukopenia and diarrhea (3%, each). Grade 4 AEs were limited to neutropenia, febrile neutropenia, and sepsis (1 episode each). For patients receiving concurrent P + C, TRAE included neutropenia and leukopenia (15%, each) and shortness of breath and bilateral bone pain (10%, each). Leukopenia (n = 2) and neutropenia (n = 1) were the only Grade 4 events reported. The analysis of quality of life (QOL) questionnaires indicated that there were no obvious differences between treatment groups during the study. These drugs and treatment schema were well-tolerated when administered in the community setting and resulted in survival rates that were similar to what is reported in the literature with combination therapy administered to "high risk" patients. Finding the optimal chemotherapy regimen, that can be tolerated, remains a challenge in elderly patients.