The Uniform grading tooL for flexIble ureterorenoscoPes (TULIP-tool): a Delphi consensus project on standardised evaluation of flexible ureterorenoscopes.

OBJECTIVE: To develop a standardised tool to evaluate flexible ureterorenoscopes (fURS). MATERIALS AND METHODS: A three-stage consensus building approach based on the modified Delphi technique was performed under guidance of a steering group. First, scope- and user-related parameters used to evaluate fURS were identified through a systematic scoping review. Then, the main categories and subcategories were defined, and the expert panel was selected. Finally, a two-step modified Delphi consensus project was conducted to firstly obtain consensus on the relevance and exact definition of each (sub)category necessary to evaluate fURS, and secondly on the evaluation method (setting, used tools and unit of outcome) of those (sub)categories. Consensus was reached at a predefined threshold of 80% high agreement. RESULTS: The panel consisted of 30 experts in the field of endourology. The first step of the modified Delphi consensus project consisted of two questionnaires with a response rate of 97% (n = 29) for both. Consensus was reached for the relevance and definition of six main categories and 12 subcategories. The second step consisted of three questionnaires (response rate of 90%, 97% and 100%, respectively). Consensus was reached on the method of measurement for all (sub)categories. CONCLUSION: This modified Delphi consensus project reached consensus on a standardised grading tool for the evaluation of fURS - The Uniform grading tooL for flexIble ureterorenoscoPes (TULIP) tool. This is a first step in creating uniformity in this field of research to facilitate future comparison of outcomes of the functionality and handling of fURS.

Iatrogenic injury of the urinary tract during salvage procedures for pelvic sepsis: Experience of a national referral centre.

AIM: This study aimed to determine the incidence, consequences and outcomes of iatrogenic urinary tract injury (IUI) during salvage surgery for pelvic sepsis. METHOD: Patients who underwent salvage surgery for pelvic sepsis after prior low anterior resection or Hartmann's procedure for rectal cancer were prospectively maintained in a database between 2010 and 2020 and reviewed retrospectively. The primary endpoint was the incidence of IUI. Secondary endpoints were timing of diagnosis (intra- vs. postoperative), reinterventions related to the IUI and healing of IUI. RESULTS: In total 126 consecutive patients were included, and IUI occurred in 13 patients (10%). A ureteric injury occurred in eight patients, bladder injury in four patients and a urethral injury in one patient. All patients with an IUI had radiotherapy as neoadjuvant treatment. The IUI was diagnosed postoperatively in 63% (n = 8/13) with a median duration between surgery and diagnosis of the IUI of 10 days (IQR: 6-15). The median number of reinterventions was five (range 1-31) in the group with a postoperative diagnosis and one (range 0-1) in the group with an intraoperative diagnosis. Four patients required a surgical reintervention, all concerning injuries diagnosed postoperatively. At the end of follow-up, 85% of patients (n = 11/13) had a healed IUI. CONCLUSION: Iatrogenic urinary tract injury is not uncommon in salvage procedures for pelvic sepsis, even in an experienced tertiary referral centre. Most injuries were diagnosed postoperatively which affects the severity of these complications, emphasising the need to improve intraoperative diagnostic modalities.

How to evaluate a flexible ureterorenoscope? Systematic mapping of existing evaluation methods.

OBJECTIVES: The objective of this study was to identify, map and review scope-related and user-related parameters used to evaluate the quality of flexible ureterorenoscopes. Thereby identifying key items and variability in grading systems. METHODS: A literature search of four databases (MEDLINE [Ovid], EMBASE [Ovid], Web of Science, Google scholar and the Cochrane Library) was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines encompassing articles published up to August 2020. A total of 2386 articles were screened. RESULTS: A total of 48 articles were included in this systematic scoping review. All studies had a prospective design. Five key items in the assessment of flexible ureterorenoscopy were distinguished: 'Manoeuvrability' (87.5%), 'Optics' (64.6%), 'Irrigation' (56.3%), 'Handling' (39.6%) and 'Durability' (35.4%). After regrouping, every key item could be divided into specific subcategories. However, the quality assessment showed a wide variation in denomination, method of measurement, circumstances of measurement, tools used during measurements, number of measurements performed, number of observers, and units of outcomes. CONCLUSION: The research field regarding quality assessment of ureterorenoscopes is heterogeneous. In this systematic scoping review we identified five key parameters: Manoeuvrability, Optics, Irrigation, Handling and Durability, used to grade flexible ureterorenoscopes. However, within these categories we found a wide variety in terms of method of measurements. A standardised, uniform grading tool is required to assess and compare the quality of flexible ureterorenoscopes in the future.

Fluoroscopy-use during ureterorenoscopy: are urologists concerned about radiation exposure? A nationwide survey in Belgium and The Netherlands.

INTRODUCTION: To evaluate the use and awareness of radiation during URS among Belgian and Dutch urologists. MATERIAL AND METHODS: An online questionnaire was send to all members of the Belgian and Dutch Association of Urology. RESULTS: 170 urologists finished the complete questionnaire. 10% of the respondents are not familiar with the ALARA-principle. 29% starts with a KUB and 48% makes an XRPG at the beginning of the procedure. 85% uses fluoroscopy to place a wire or ureteral access sheet, 18% during stone treatment, 59% to screen for missed stones or calyces, 90% to place a JJ-stent or ureter-catheter and 23% to check for extravasation. 82% do not document radiation data. 51% does not wear a dosimeter during fluoroscopy. Almost all wear a lead apron during fluoroscopy, 47% uses additional thyroid shields and only 4% uses lead glasses. 88% intentionally reduces fluoroscopy time, 75% reduces the exposed area with a diaphragm, 72% brings the radiation source close to the patient and 44% uses pulsed fluoroscopy. CONCLUSION: There is a wide variety in the use and awareness of radiation during URS. To further reduce radiation and its negative effect for patients and medical staff, awareness about radiation safety should increase among urologists.

Contrast-enhanced ultrasound with dispersion analysis for the localization of prostate cancer: correlation with radical prostatectomy specimens.

PURPOSE: To determine the value of two-dimensional (2D) contrast-enhanced ultrasound (CEUS) imaging and the additional value of contrast ultrasound dispersion imaging (CUDI) for the localization of clinically significant prostate cancer (csPCa). METHODS: In this multicentre study, subjects scheduled for a radical prostatectomy underwent 2D CEUS imaging preoperatively. CUDI maps were generated from the CEUS recordings. Both CEUS recordings and CUDI maps were scored on the likelihood of presenting csPCa (any Gleason ≥ 4 + 3 and Gleason 3 + 4 larger than 0.5 mL) by five observers and compared to radical prostatectomy histopathology. An automated three-dimensional (3D) fusion protocol was used to match imaging with histopathology. Receiver operator curve (ROC) analysis was performed per observer and imaging modality. RESULTS: 133 of 216 (62%) patients were included in the final analysis. Average area under the ROC for all five readers for CEUS, CUDI and the combination was 0.78, 0.79 and 0.78, respectively. This yields a sensitivity and specificity of 81 and 64% for CEUS, 83 and 56% for CUDI and 83 and 55% for the combination. Interobserver agreement for CEUS, CUDI and the combination showed kappa values of 0.20, 0.18 and 0.18 respectively. CONCLUSION: The sensitivity and specificity of 2D CEUS and CUDI for csPCa localization are moderate. Despite compressing CEUS in one image, CUDI showed a similar performance to 2D CEUS. With a sensitivity of 83% at cutoff point 3, it could become a useful imaging procedure, especially with 4D acquisition, improved quantification and combination with other US imaging techniques such as elastography.

Three-dimensional greyscale transrectal ultrasound-guidance and biopsy core preembedding for detection of prostate cancer: Dutch clinical cohort study.

BACKGROUND: To overcome the limitations regarding two dimensional (2D) greyscale (GS) transrectal ultrasound (TRUS)-guided biopsy in prostate cancer (PCa) detection and tissue packaging in biopsy processing, there is an ongoing focus on new imaging and pathology techniques. A three-dimensional (3D) model of the prostate with biopsy needle guidance can be generate by the Navigo™ workstation (UC-care, Israel). The SmartBX™ system (UC-care, Israel) provides a prostate biopsy core preembedding method. The aim of this study was to compare cancer detection rates between the 3D TRUS-guidance and preembedding method with conventional 2D GS TRUS-guidance among patients undergoing prostate biopsies. METHODS: We retrospectively analyzed the records of all patients who underwent prostate biopsies for PCa detection at our institution from 2007 to 2016. The cohort was divided into a 2D GS TRUS-guidance cohort (from 2007 to 2013, n = 1149) and a 3D GS TRUS-guidance with preembedding cohort (from 2013 to 2016, n = 469). Effect of 3D GS TRUS-guidance with preembedding on detection rate of PCa and clinically significant PCa (Gleason score ≥ 7 or > 2 biopsy cores with a Gleason score 6) was compared to 2D GS TRUS-guidance using regression models. RESULTS: Detection rate of PCa and clinically significant PCa was 39.0 and 24.9% in the 3D GS TRUS cohort compared to 33.5 and 19.0% in the 2D GS TRUS cohort, respectively. On multivariate regression analysis the use of 3D GS TRUS-guidance with preembedding was associated with a significant increase in detection rate of PCa (aOR = 1.33; 95% CI: 1.03-1.72) and clinically significant PCa (aOR = 1.47; 95% CI: 1.09-1.98). CONCLUSION: Our results suggest that 3D GS TRUS-guidance with biopsy core preembedding improves PCa and clinically significant PCa detection compared to 2D GS TRUS-guidance. Additional studies are needed to justify the application of these systems in clinical practice.

Concordance of Gleason grading with three-dimensional ultrasound systematic biopsy and biopsy core pre-embedding.

PURPOSE: To determine the value of a three-dimensional (3D) greyscale transrectal ultrasound (TRUS)-guided prostate biopsy system and biopsy core pre-embedding method on concordance between Gleason scores of needle biopsies and radical prostatectomy (RP) specimens. METHODS: Retrospective analysis of prostate biopsies and subsequent RP for PCa in the Jeroen Bosch Hospital, the Netherlands, from 2007 to 2016. Two cohorts were analysed: conventional 2D TRUS-guided biopsies and RP (2007-2013, n = 266) versus 3D TRUS-guided biopsies with pre-embedding (2013-2016, n = 129). The impact of 3D TRUS-guidance with pre-embedding on Gleason score (GS) concordance between biopsy and RP was evaluated using the κ-coefficient. Predictors of biopsy GS 6 upgrading were assessed using logistic regression models. RESULTS: Gleason concordance was comparable between the two cohorts with a κ = 0.44 for the 3D cohort, compared to κ = 0.42 for the 2D cohort. 3D TRUS-guidance with pre-embedding, did not significantly affect the risk of biopsy GS 6 upgrading in univariate and multivariate analysis. CONCLUSIONS: 3D TRUS-guidance with biopsy core pre-embedding did not improve Gleason concordance. Improved detection techniques are needed for recognition of low-grade disease upgrading.

The value of magnetic resonance imaging and ultrasonography (MRI/US)-fusion biopsy platforms in prostate cancer detection: a systematic review.

Despite limitations considering the presence, staging and aggressiveness of prostate cancer, ultrasonography (US)-guided systematic biopsies (SBs) are still the 'gold standard' for the diagnosis of prostate cancer. Recently, promising results have been published for targeted prostate biopsies (TBs) using magnetic resonance imaging (MRI) and ultrasonography (MRI/US)-fusion platforms. Different platforms are USA Food and Drug Administration registered and have, mostly subjective, strengths and weaknesses. To our knowledge, no systematic review exists that objectively compares prostate cancer detection rates between the different platforms available. To assess the value of the different MRI/US-fusion platforms in prostate cancer detection, we compared platform-guided TB with SB, and other ways of MRI TB (cognitive fusion or in-bore MR fusion). We performed a systematic review of well-designed prospective randomised and non-randomised trials in the English language published between 1 January 2004 and 17 February 2015, using PubMed, Embase and Cochrane Library databases. Search terms included: 'prostate cancer', 'MR/ultrasound(US) fusion' and 'targeted biopsies'. Extraction of articles was performed by two authors (M.G. and A.A.) and were evaluated by the other authors. Randomised and non-randomised prospective clinical trials comparing TB using MRI/US-fusion platforms and SB, or other ways of TB (cognitive fusion or MR in-bore fusion) were included. In all, 11 of 1865 studies met the inclusion criteria, involving seven different fusion platforms and 2626 patients: 1119 biopsy naïve, 1433 with prior negative biopsy, 50 not mentioned (either biopsy naïve or with prior negative biopsy) and 24 on active surveillance (who were disregarded). The Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool was used to assess the quality of included articles. No clear advantage of MRI/US fusion-guided TBs was seen for cancer detection rates (CDRs) of all prostate cancers. However, MRI/US fusion-guided TBs tended to give higher CDRs for clinically significant prostate cancers in our analysis. Important limitations of the present systematic review include: the limited number of included studies, lack of a general definition of 'clinically significant' prostate cancer, the heterogeneous study population, and a reference test with low sensitivity and specificity. Today, a limited number of prospective studies have reported the CDRs of fusion platforms. Although MRI/US-fusion TB has proved its value in men with prior negative biopsies, general use of this technique in diagnosing prostate cancer should only be performed after critical consideration. Before bringing MRI/US fusion-guided TB in to general practice, there is a need for more prospective studies on prostate cancer diagnosis.

3D Navigo™ versus TRUS-guided prostate biopsy in prostate cancer detection.

INTRODUCTION: To overcome the limitations regarding transrectal ultrasound (TRUS)-guided biopsies in prostate cancer (PCa) detection, there is a focus on new imaging technologies. The Navigo™ system (UC-care, Israel) uses regular TRUS images and electrospatial monitoring to generate a 3D model of the prostate. The aim of this study was to compare cancer detection rates between the Navigo™ system and conventional TRUS, in patients without a history of PCa. METHODS: We performed a retrospective study by collecting data from all patients who underwent 12-core prostate biopsies from lateral peripheral zones between September 2013 and February 2015 at the Jeroen Bosch Hospital in 's-Hertogenbosch (Netherlands). RESULTS: A total of 325 patients met our inclusion criteria. 77.8 % of biopsy sessions were performed using the Navigo™ system. There was no statistically significant difference in PCa detection (39.9 vs 46.2 % with Navigo™ system and TRUS, respectively). Using the Navigo™ system for taking prostate biopsies proved not to be associated with the presence of PCa at biopsy, likewise for clinically significant PCa and for both subgroups. LIMITATIONS: The limitations of the study include its retrospective design, the limited number of patients in the conventional TRUS group, the statistically significant different number of biopsy sessions and the ones performed by an advanced physician in both groups. CONCLUSION: In our study, there is no added value of 3D TRUS using Navigo™ system compared to conventional 2D TRUS regarding PCa detection in biopsy-naive men and men with prior negative biopsy.

Heavy as a rock or light as dust: a comparison between the perceived workload for extracorporeal shockwave lithotripsy, ureterorenoscopy and percutaneous nephrolithotomy.

Introduction: There are three common treatment options for kidney stones: extracorporeal shockwave lithotripsy (ESWL), ureterorenoscopy (URS) and percutaneous nephrolithotomy (PNL). The choice of treatment is based on stone- and patient-related characteristics. However, some stones are eligible for several approaches and the decision is made based on patient and urologist's preferences. This study evaluates which approach has the highest workload. Material and methods: Between March and August 2022, five members of the Amsterdam Endourology Research Group collected data from 22 ESWL, 31 URS and 22 PNL procedures. After each procedure, the SURG-TLX questionnaire was completed by the surgeon to evaluate workload. Six dimensions were scored for each procedure, including: mental demands, physical demands, temporal demands, task complexity, situational stress, and distractions. The total workload, and the median for each dimension, was calculated and compared for the three treatments. Results: ESWL scored significantly lower than URS for mental demands, physical demands, temporal demands, situational stress, distraction and total workload. However, task complexity did not differ significantly between the two techniques. Compared with PNL, ESWL scored significantly lower for all dimensions. Finally, PNL received significantly higher scores for mental demands, physical demands, temporal demands, situational stress, distractions and total workload than URS. Only task complexity showed no significant difference between both groups. Conclusions: Urologists perceive the highest workload during PNL, followed by URS and finally ESWL. A follow-up study is needed to identify stressors that increase perceived workload with the purpose to address these variables and as final objective to improve urologists' workload, patient safety and treatment outcomes.

Surgeon Preference and Clinical Outcome of 3D Vision Compared to 2D Vision in Laparoscopic Surgery: Systematic Review and Meta-Analysis of Randomized Trials.

Objective: To assess the added value of 3-dimensional (3D) vision, including high definition (HD) technology, in laparoscopic surgery in terms of surgeon preference and clinical outcome. Background: The use of 3D vision in laparoscopic surgery has been suggested to improve surgical performance. However, the added value of 3D vision remains unclear as a systematic review of randomized controlled trials (RCTs) comparing 3D vision including HD technology in laparoscopic surgery is currently lacking. Methods: A systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines with a literature search up to May 2023 using PubMed and Embase (PROSPERO, CRD42021290426). We included RCTs comparing 3D versus 2-dimensional (2D) vision in laparoscopic surgery. The primary outcome was operative time. Meta-analyses were performed using the random effects model to estimate the pooled effect size expressed in standard mean difference (SMD) with corresponding 95% confidence intervals (CIs). The level of evidence and quality was assessed according to the Cochrane risk of bias tool. Results: Overall, 25 RCTs with 3003 patients were included. Operative time was reduced by 3D vision (-8.0%; SMD, -0.22; 95% CI, -0.37 to -0.06; P = 0.007; n = 3003; 24 studies; I 2 = 75%) compared to 2D vision. This benefit was mostly seen in bariatric surgery (-16.3%; 95% CI, -1.28 to -0.21; P = 0.006; 2 studies; n = 58; I 2 = 0%) and general surgery (-6.7%; 95% CI, -0.34 to -0.01; P = 0.036; 9 studies; n = 1056; I 2 = 41%). Blood loss was nonsignificantly reduced by 3D vision (SMD, -0.33; 95% CI, -0.68 to 0.017; P = 0.060; n = 1830; I 2 = 92%). No differences in the rates of morbidity (14.9% vs 13.5%, P = 0.644), mortality (0% vs 0%), conversion (0.8% vs 0.9%, P = 0.898), and hospital stay (9.6 vs 10.5 days, P = 0.078) were found between 3D and 2D vision. In 15 RCTs that reported on surgeon preference, 13 (87%) reported that the majority of surgeons favored 3D vision. Conclusions: Across 25 RCTs, this systematic review and meta-analysis demonstrated shorter operative time with 3D vision in laparoscopic surgery, without differences in other outcomes. The majority of surgeons participating in the RCTs reported in favor of 3D vision.

The Impact of a Multidisciplinary Tumor Board (MTB) on Treatment Decision Making for Patients With Renal Cell Carcinoma (RCC): 5-Year Data Analysis.

OBJECTIVE: To describe the impact of a multidisciplinary tumor board (MTB) for renal cell carcinoma (RCC) patients in a locoregional renal cancer network by evaluating shared decision making (SDM) and adherence to MTB recommendations. DESIGN, SETTING AND PARTICIPANTS: This prospective cohort study included all cases from a Dutch renal cancer network with suspicion of or histologically confirmed RCC discussed in MTBs between 2017-2022. Main endpoints were distribution of cases presented, proportion of recommendations with multiple treatment options enabling shared decision making (SDM), definite treatment after SDM and adherence to MTB recommendations. Further endpoints were definite treatment per tumor stage stratified by age and inclusion in clinical trials. Outcomes were displayed as means and proportions (%). Pearson's Chi-Squared test was used to analyze the effect of age on definite treatment advice. RESULTS: Overall, 2651 cases were discussed, of which 1900 (72%) were new referrals and 751 (28%) rediscussions. Majority of cases were cT1a-b tumors (46%) and 22% were local recurrences or metachronous metastatic. Adherence to MTB recommendation was 96% and in 30% multiple treatment options were recommended, allowing for SDM. In 45% of cases with cT1a tumors multiple treatment options were recommended by the MTB, resulting in (cryo)ablation (32%) and AS (30%) as most frequent definite treatments after SDM. Among patients with cT3-4 tumors the inclusion rate in clinical trials was 47%. CONCLUSIONS: A network MTB creates opportunity to discuss multiple treatment options and clinical trials in SDM with patients at a high rate of adherence to MTB recommendation.

A Systematic Review on the Impact of Quality Assurance Programs on Outcomes after Radical Prostatectomy.

BACKGROUND AND OBJECTIVE: The implementation of quality assurance programs (QAPs) within urological practice has gained prominence; yet, their impact on outcomes after radical prostatectomy (RP) remains uncertain. This paper aims to systematically review the current literature regarding the implementation of QAPs and their impact on outcomes after robot-assisted RP, laparoscopic RP, and open prostatectomy, collectively referred to as RP. METHODS: A systematic Embase, Medline (OvidSP), and Scopus search was conducted, according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) process, on January 12, 2024. Studies were identified and included if these covered implementation of QAPs and their impact on outcomes after RP. QAPs were defined as any intervention seeking quality improvement through critically reviewing, analyzing, and discussing outcomes. Included studies were assessed critically using the Risk of Bias in Nonrandomized Studies of Interventions (ROBINS-I) tool, with results summarized narratively. KEY FINDINGS AND LIMITATIONS: Ten included studies revealed two methodological strategies: periodic performance feedback and surgical video assessments. Despite conceptual variability, QAPs improved outcomes consistently (ie, surgical margins, urine continence, erectile function, and hospital readmissions). Of the two strategies, video assessments better identified suboptimal surgical practice and technical errors. Although the extent of quality improvements did not appear to correlate with the frequency of QAPs, there was an apparent correlation with whether or not outcomes were evaluated collectively. CONCLUSIONS AND CLINICAL IMPLICATIONS: Current findings suggest that QAPs have a positive impact on outcomes after RP. Caution in interpretation due to limited data is advised. More extensive research is required to explore how conceptual differences impact the extent of quality improvements. PATIENT SUMMARY: In this paper, we review the available scientific literature regarding the implementation of quality assurance programs and their impact on outcomes after radical prostatectomy. The included studies offered substantial support for the implementation of quality assurance programs as an incentive to improve the quality of care continuously.

Achieving consensus on the definition of conversion to laparotomy: a Delphi study among general surgeons, gynecologists, and urologists.

BACKGROUND: In laparoscopic surgery, conversion to laparotomy is associated with worse clinical outcomes, especially if the conversion is due to a complication. Although apparently important, no commonly used definition of conversion exists. The aim of this study was to achieve multidisciplinary consensus on a uniform definition of conversion. METHODS: On the basis of definitions currently used in the literature, a web-based Delphi consensus study was conducted among members of all four Dutch endoscopic societies. The rate of agreement (RoA) was calculated; a RoA of >70% suggested consensus. RESULTS: The survey was completed by 268 respondents in the first Delphi round (response rate, 45.6%); 43% were general surgeons, 49% gynecologists, and 8% urologists. Average ± standard deviation laparoscopic experience was 12.5 ± 7.2 years. On the basis of the results of round 1, a consensus definition was compiled. Conversion to laparotomy is an intraoperative switch from a laparoscopic to an open abdominal approach that meets the criteria of one of the two subtypes: strategic conversion, a standard laparotomy that is made directly after the assessment of the feasibility of completing the procedure laparoscopically and because of anticipated operative difficulty or logistic considerations; and reactive conversion, the need for a laparotomy because of a complication or (extension of an incision) because of (anticipated) operative difficulty after a considerable amount of dissection (i.e., >15 min in time). A laparotomy after a diagnostic laparoscopy (i.e., to assess the curability of the disease) should not be considered a conversion. In the second Delphi round, a RoA of 90% was achieved with this definition. CONCLUSIONS: After two Delphi rounds, consensus on a uniform multidisciplinary definition of conversion was achieved within a representative group of general surgeons, gynecologists, and urologists. An unambiguous interpretation will result in a more reliable clinical registration of conversion and scientific evaluation of the feasibility of a laparoscopic procedure.

Corrigendum to "Clinical Trial Protocol: Developing an Image Classification Algorithm for Prostate Cancer Diagnosis on Three-dimensional Multiparametric Transrectal Ultrasound" [Eur. Urol. Open Sci. 49 (2023) 32-43].

[This corrects the article DOI: 10.1016/j.euros.2022.12.018.].

Clinical Trial Protocol: Developing an Image Classification Algorithm for Prostate Cancer Diagnosis on Three-dimensional Multiparametric Transrectal Ultrasound.

Introduction and hypothesis: The tendency toward population-based screening programs for prostate cancer (PCa) is expected to increase demand for prebiopsy imaging. This study hypothesizes that a machine learning image classification algorithm for three-dimensional multiparametric transrectal prostate ultrasound (3D mpUS) can detect PCa accurately. Design: This is a phase 2 prospective multicenter diagnostic accuracy study. A total of 715 patients will be included in a period of approximately 2 yr. Patients are eligible in case of suspected PCa for which prostate biopsy is indicated or in case of biopsy-proven PCa for which radical prostatectomy (RP) will be performed. Exclusion criteria are prior treatment for PCa or contraindications for ultrasound contrast agents (UCAs). Protocol overview: Study participants will undergo 3D mpUS, consisting of 3D grayscale, 4D contrast-enhanced ultrasound, and 3D shear wave elastography (SWE). Whole-mount RP histopathology will provide the ground truth to train the image classification algorithm. Patients included prior to prostate biopsy will be used for subsequent preliminary validation. There is a small, anticipated risk for participants associated with the administration of a UCA. Informed consent has to be given prior to study participation, and (serious) adverse events will be reported. Statistical analysis: The primary outcome will be the diagnostic performance of the algorithm for detecting clinically significant PCa (csPCa) on a per-voxel and a per-microregion level. Diagnostic performance will be reported as the area under the receiver operating characteristic curve. Clinically significant PCa is defined as the International Society of Urological grade group ≥2. Full-mount RP histopathology will be used as the reference standard. Secondary outcomes will be sensitivity, specificity, negative predictive value, and positive predictive value for csPCa on a per-patient level, evaluated in patients included prior to prostate biopsy, using biopsy results as the reference standard. A further analysis will be performed on the ability of the algorithm to differentiate between low-, intermediate-, and high-risk tumors. Discussion and summary: This study aims to develop an ultrasound-based imaging modality for PCa detection. Subsequent head-to-head validation trials with magnetic resonance imaging have to be performed in order to determine its role in clinical practice for risk stratification in patients suspected for PCa.

Longer is Better for Endoscopic Follow-up of Upper Tract Urothelial Carcinoma After Ureteroscopic Treatment: An Evaluation Spanning 10 Years of Data.

BACKGROUND: Tumour recurrences are frequent among patients with upper tract urothelial carcinoma (UTUC) treated with ureteroscopy (URS). Therefore, guidelines recommend a strict follow-up regimen, but there is little evidence on how to do this. OBJECTIVE: To analyse outcomes during our follow-up regimen and the impact on treatment in terms of ipsilateral UTUC recurrence, treatment conversion, and tumour upgrading, and to evaluate potential prognostic factors, including second-look URS outcomes. A secondary objective was to evaluate survival outcomes. DESIGN, SETTING, AND PARTICIPANTS: The single-centre cohort included all adult patients with nonmetastatic UTUC treated with URS from January 2010 to December 2020. Follow-up involved endoscopy at 3-mo intervals in the first year, then at 6-mo intervals up to year 3, and yearly thereafter. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Descriptive analyses were performed for the follow-up outcomes. The Andersen-Gill model for recurrent event analysis was used to analyse tumour recurrences, and multivariable Cox regression to analyse for predictors for treatment conversion in low-grade tumours. RESULTS AND LIMITATIONS: We analysed 71 patients with median follow-up of 49.5 mo. The overall 2-yr recurrence-free survival (RFS) rate was 22%. In low-grade disease, the 1-yr RFS rate was 50% and the 2-yr RFS rate was 29%. Treatment was converted to radical nephroureterectomy for 23 patients, at a median time to conversion of 9.9 mo. Upgrading was seen in 13 patients, at a median time to upgrading of 21.9 mo. No factors were prognostic for either tumour recurrence or treatment conversion. The 5-yr OS, CSS, and MFS rates were 82%, 86%, and 84%, respectively. CONCLUSIONS: Our data show that it is rational to extend endoscopic follow-up for UTUC treated with URS, as clinically relevant events (treatment conversion and tumour upgrading) occur beyond the current 6-mo guideline recommendation. Second-look URS outcomes were not prognostic for tumour recurrence or treatment conversion during follow-up. PATIENT SUMMARY: Our study results show that for patients with cancer of the upper urinary tract treated with kidney-sparing surgery through a small telescope called a ureteroscope (URS), most of the clinically relevant events (treatment conversion and tumour upgrading) occur outside the current recommended follow-up of 6 months. Therefore, URS follow-up should be extended for these patients.

Reliability of whole mount radical prostatectomy histopathology as the ground truth for artificial intelligence assisted prostate imaging.

The development of artificial intelligence-based imaging techniques for prostate cancer (PCa) detection and diagnosis requires a reliable ground truth, which is generally based on histopathology from radical prostatectomy specimens. This study proposes a comprehensive protocol for the annotation of prostatectomy pathology slides. To evaluate the reliability of the protocol, interobserver variability was assessed between five pathologists, who annotated ten radical prostatectomy specimens consisting of 74 whole mount pathology slides. Interobserver variability was assessed for both the localization and grading of PCa. The results indicate excellent overall agreement on the localization of PCa (Gleason pattern ≥ 3) and clinically significant PCa (Gleason pattern ≥ 4), with Dice similarity coefficients (DSC) of 0.91 and 0.88, respectively. On a per-slide level, agreement for primary and secondary Gleason pattern was almost perfect and substantial, with Fleiss Kappa of .819 (95% CI .659-.980) and .726 (95% CI .573-.878), respectively. Agreement on International Society of Urological Pathology Grade Group was evaluated for the index lesions and showed agreement in 70% of cases, with a mean DSC of 0.92 for all index lesions. These findings show that a standardized protocol for prostatectomy pathology annotation provides reliable data on PCa localization and grading, with relatively high levels of interobserver agreement. More complicated tissue characterization, such as the presence of cribriform growth and intraductal carcinoma, remains a source of interobserver variability and should be treated with care when used in ground truth datasets.

Reliable Visualization of the Treatment Effect of Transperineal Focal Laser Ablation in Prostate Cancer Patients by Magnetic Resonance Imaging and Contrast-enhanced Ultrasound Imaging.

Background: Transperineal focal laser ablation (TPLA) treatment for prostate cancer (PCa) is an experimental focal ablative therapy modality with low morbidity. However, a dosimetry model for TPLA is lacking. Objective: To determine (1) the three-dimensional (3D) histologically defined ablation zone of single- and multifiber TPLA treatment for PCa correlated with magnetic resonance imaging (MRI) and contrast-enhanced ultrasound (CEUS) and (2) a reliable imaging modality of ablation zone volumetry. Design setting and participants: This was a prospective, multicenter, and interventional phase I/II pilot study with an ablate-and-resect design. TPLA was performed in 12 patients with localized prostate cancer divided over four treatment regimens to evaluate potential variation in outcomes. Intervention: TPLA was performed approximately 4 wk prior to robot-assisted radical prostatectomy (RARP) in a daycare setting using local anesthesia. Outcome measurements and statistical analysis: Four weeks after TPLA, ablation zone volumetry was determined on prostate MRI and CEUS by delineation and segmentation into 3D models and correlated with whole-mount RARP histology using the Pearson correlation index. Results and limitations: Twelve office-based TPLA procedures were performed successfully under continuous transrectal ultrasound guidance using local perineal anesthesia. No serious adverse events occurred. A qualitative analysis showed a clear demarcation of the ablation zone on T2-weighted MRI, dynamic contrast-enhanced MRI, and CEUS. On pathological evaluation, no remnant cancer was observed within the ablation zone. Ablation zone volumetry on CEUS and T2-weighted MRI compared with histology had a Pearson correlation index of r = 0.94 (95% confidence interval [CI] 0.74-0.99, p < 0.001) and r = 0.93 (95% CI 0.73-0.98, p < 0.001), respectively. Conclusions: CEUS and prostate MRI could reliably visualize TPLA ablative effects after minimally invasive PCa treatment with a high concordance with histopathological findings and showed no remnant cancer. Patient summary: The treatment effects of a novel minimally invasive ablation therapy device can reliably be visualized with radiological examinations. These results will improve planning and performance of future procedures.

Is It the Load That Breaks You or the Way You Carry It: How Demanding Is Endourology?

Objective: Surgical outcomes are dependent on multiple factors. Besides patient-related or procedure-related factors, several surgeon-related factors contribute to surgical outcomes. The Surgery Task Load Index (SURG-TLX) questionnaire helps to assess the impact of several stressors on the perceived demands of surgeons during surgery. In this study, we evaluate the applicability of the SURG-TLX questionnaire for endourologic procedures and set a first point of reference. Materials and Methods: Between March and August 2022, 15 urologists and urology residents at a tertiary referral center for endourology completed the SURG-TLX questionnaire after endourologic procedures. After data acquisition, all participants were asked to evaluate the applicability of the questionnaire for endourologic procedures. Results: A total of 130 procedures were included between March and August 2022. Situational stress had the lowest median score (3.0/20; interquartile range [IQR] 2.0-7.0) and task complexity the highest (5.0/20; IQR 3.0-8.0). After weighing, the dimensions showed different proportions when compared with the nonweighted scores. Distractions received the highest score (15.0/100; IQR 7.5-32.8), temporal demands (6.0/100; IQR 3.0-12.5), and situational stress the lowest (6.0/100; IQR 2.0-21.0). This was caused by the higher weight that was attributed to distractions (3.4/5), as opposed to task complexity (2.6/5). In the questionnaire regarding applicability of the SURG-TLX, the overall satisfaction (6.0/10; IQR 5.0-7.0) and clarity (6.5/10; IQR 5.0-7.5) were moderate. The user-friendliness and applicability of the questionnaire were rated high (7.0/10; IQR 5.5-8.0 and 7.0/10; IQR 6.0-8.0, respectively) and task load (3.0/10; IQR 2.0-5.0) and time load (2.0/10; IQR 2.0-3.5) low. Conclusion: The SURG-TLX questionnaire is appropriate to assess the different dimensions of workload during endourologic procedures. Furthermore, the perceived workload during endourologic procedures is relatively low.