Laterally Extended Endopelvic Resection of Recurrent Epithelioid Trophoblastic Tumor by Laparoscopy.

We report the resection of a recurrent epithelioid trophoblastic tumor by laparoscopic laterally extended endopelvic resection (LEER). The LEER technique was developed to resect en bloc multiple visceral compartments involving the lateral pelvic wall with negative margins for local control of advanced and recurrent malignancies. Described by Höckel, this procedure is usually performed by a midline laparotomy. Our patient had undergone prior laparotomic surgery including hysterectomy, partial bladder resection, and a right ureteral reimplantation for an epithelioid trophoblastic tumor without adjuvant treatment. She presented a recurrent tumor infiltrating the bladder, the ureter, and the right pelvic wall as well as the internal and external iliac vessels. A vascular surgeon first performed a femorofemoral bypass by bilateral groin incisions with a subcutaneous tunnel. The surgery was then exclusively performed by laparoscopy using the LEER technique including resection of both external and internal iliac vessels and the pelvic wall through the lateral pelvic muscles and iterative bladder resection associated with a ureteral reimplantation using the psoas hitch bladder technique. The patient experienced Clavien-Dindo classification grade II postoperative complications. Histology showed a margin-free resection (R0).

Construct, content and face validity of the camera handling trainer (CHT): a new E-BLUS training task for 30° laparoscope navigation skills.

PURPOSE: Assessing construct, face and content validity of the camera handling trainer (CHT), a novel low-fidelity training device for 30° laparoscope navigation skills. METHODS: We developed a custom-designed box trainer with clinically based graphic targets. A total of 117 participants, stratified according to their previous experience (novice, competent, expert), took part to a CHT session and subsequently were asked to fill out a survey to assess the impact of the CHT on their 30° laparoscope navigation skills. Sixty of them were also studied for task performance during a 1-h session, with multiple time measurements. RESULTS: All participants, regardless of the previous experience, significantly improved their performance after the CHT session. Regarding construct validity, the mean task performance on the last measurement for novice group was found to be comparable to the mean first attempt of both competent (p = 0.12) and expert (p = 0.24) participants. All participants agreed that "the CHT is a valid training tool" and that "the CHT should be part of the regular dry laboratory training sessions", assessing both face and content validity. Limitations include the need for assessment of predictive validity. CONCLUSIONS: The CHT is a valid training tool for 30° laparoscope navigation and thus should be considered as one of the fundamental exercises during basic laparoscopic hands-on training sessions for urologists.

A multi-center international study to evaluate the safety, functional and oncological outcomes of irreversible electroporation for the ablation of prostate cancer.

BACKGROUND: Irreversible electroporation (IRE) is a novel technique to treat localized prostate cancer with the aim of achieving oncological control while reducing related side effects. We present the outcomes of localized prostate cancer treated with IRE from a multi-center prospective registry. METHODS: Men with histologically confirmed prostate cancer were recruited to receive IRE. All the patients were proposed for prostate biopsy at 1-year post-IRE ablation. The functional outcomes were measured by the International Prostate Symptom Score (IPSS) and International Index of Erectile Function (IIEF-5) questionnaires. The safety of IRE was graded by the treatment-related adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE). RESULTS: 411 patients were recruited in this study from July 2015 to April 2020. The median follow-up time was 24 months (IQR 15-36). 116 patients underwent repeat prostate biopsy during 12-18 months after IRE. Clinically significant prostate cancer (Gleason ≥ 3 + 4) was detected in 24.1% (28/116) of the patients; any grade prostate cancers were found in 59.5% (69/116) of the patients. The IPSS score increased significantly from 7.1 to 8.2 (p = 0.015) at 3 months but decreased to 6.1 at 6 months (p = 0.017). Afterwards, the IPSS level remained stable during follow-up. The IIEF-5 score decreased at 3 months from 16.0 to 12.1 (p < 0.001) and then maintained equable afterwards. The rate of AEs was 1.8% at 3 months and then dropped to less than 1% at 6 months and remained stable until 48 months after IRE. Major AEs (Grade 3 or above) were rare. CONCLUSION: For men with localized prostate cancer, IRE could achieve good urinary and sexual function outcomes and a reasonable oncological result. The real-world data are consistent with earlier studies, including recently published randomized controlled studies. The long-term oncological results need further investigation and follow-up.

Second TURB, restaging TURB or repeat TURB in primary T1 non-muscle invasive bladder cancer: impact on prognosis?

PURPOSE: A re-transurethral resection of the bladder (re-TURB) is a well-established approach in managing non-muscle invasive bladder cancer (NMIBC) for various reasons: repeat-TURB is recommended for a macroscopically incomplete initial resection, restaging-TURB is required if the first resection was macroscopically complete but contained no detrusor muscle (DM) and second-TURB is advised for all completely resected T1-tumors with DM in the resection specimen. This study assessed the long-term outcomes after repeat-, second-, and restaging-TURB in T1-NMIBC patients. METHODS: Individual patient data with tumor characteristics of 1660 primary T1-patients (muscle-invasion at re-TURB omitted) diagnosed from 1990 to 2018 in 17 hospitals were analyzed. Time to recurrence, progression, death due to bladder cancer (BC), and all causes (OS) were visualized with cumulative incidence functions and analyzed by log-rank tests and multivariable Cox-regression models stratified by institution. RESULTS: Median follow-up was 45.3 (IQR 22.7-81.1) months. There were no differences in time to recurrence, progression, or OS between patients undergoing restaging (135 patients), second (644 patients), or repeat-TURB (84 patients), nor between patients who did or who did not undergo second or restaging-TURB. However, patients who underwent repeat-TURB had a shorter time to BC death compared to those who had second- or restaging-TURB (multivariable HR 3.58, P = 0.004). CONCLUSION: Prognosis did not significantly differ between patients who underwent restaging- or second-TURB. However, a worse prognosis in terms of death due to bladder cancer was found in patients who underwent repeat-TURB compared to second-TURB and restaging-TURB, highlighting the importance of separately evaluating different indications for re-TURB.

Prognosis of Primary Papillary Ta Grade 3 Bladder Cancer in the Non-muscle-invasive Spectrum.

BACKGROUND: Ta grade 3 (G3) non-muscle-invasive bladder cancer (NMIBC) is a relatively rare diagnosis with an ambiguous character owing to the presence of an aggressive G3 component together with the lower malignant potential of the Ta component. The European Association of Urology (EAU) NMIBC guidelines recently changed the risk stratification for Ta G3 from high risk to intermediate, high, or very high risk. However, prognostic studies on Ta G3 carcinomas are limited and inconclusive. OBJECTIVE: To evaluate the prognostic value of categorizing Ta G3 compared to Ta G2 and T1 G3 carcinomas. DESIGN, SETTING, AND PARTICIPANTS: Individual patient data for 5170 primary Ta-T1 bladder tumors from 17 hospitals were analyzed. Transurethral resection of the tumor was performed between 1990 and 2018. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Time to recurrence and time to progression were analyzed using cumulative incidence functions, log-rank tests, and multivariable Cox-regression models with interaction terms stratified by institution. RESULTS AND LIMITATIONS: Ta G3 represented 7.5% (387/5170) of Ta-T1 carcinomas of which 42% were classified as intermediate risk. Time to recurrence did not differ between Ta G3 and Ta G2 (p = 0.9) or T1 G3 (p = 0.4). Progression at 5 yr occurred for 3.6% (95% confidence interval [CI] 2.7-4.8%) of Ta G2, 13% (95% CI 9.3-17%) of Ta G3, and 20% (95% CI 17-23%) of T1 G3 carcinomas. Time to progression for Ta G3 was shorter than for Ta G2 (p < 0.001) and longer than for T1 G3 (p = 0.002). Patients with Ta G3 NMIBC with concomitant carcinoma in situ (CIS) had worse prognosis and a similar time to progression as for patients with T1 G3 NMIBC with CIS (p = 0.5). Multivariable analyses for recurrence and progression showed similar results. CONCLUSIONS: The prognosis of Ta G3 tumors in terms of progression appears to be in between that of Ta G2 and T1 G3. However, patients with Ta G3 NMIBC with concomitant CIS have worse prognosis that is comparable to that of T1 G3 with CIS. Our results support the recent EAU NMIBC guideline changes for more refined risk stratification of Ta G3 tumors because many of these patients have better prognosis than previously thought. PATIENT SUMMARY: We used data from 17 centers in Europe and Canada to assess the prognosis for patients with stage Ta grade 3 (G3) non-muscle-invasive bladder cancer (NMIBC). Time to cancer progression for Ta G3 cancer differed from both Ta G2 and T1 G3 tumors. Our results support the recent change in the European Association of Urology guidelines for more refined risk stratification of Ta G3 NMIBC because many patients with this tumor have better prognosis than previously thought.

The SAFE Pilot Trial-SAlvage Focal Irreversible Electroporation-For Recurrent Localized Prostate Cancer: Rationale and Study Protocol.

Introduction: Currently, the majority of prostate cancer (PCa) recurrences after non-surgical first-line treatment are managed with androgen-deprivation therapy (ADT). Salvage radical prostatectomy (sRP) is a curative alternative to ADT but yields significant morbidity. Preliminary evidence from focal salvage treatments shows similar oncological control but lower morbidity compared to sRP. Among available ablative focal energies, irreversible electroporation (IRE) is a treatment modality that proved promising, especially in treating apical lesions, where PCa most often recurs. Our aim is to test the safety of salvage IRE for recurrent PCa. Methods: We performed a single-arm pilot feasibility study (IDEAL stage 2a): SAFE, SAlvage Focal irreversible Electroporation for recurrent localized PCa. Twenty patients with biopsy-proven PCa recurrence after primary non-surgical (radiation or ablation) treatment were included. All men will undergo mpMRI ± targeted biopsies, pre-operative PSMA-PET staging before inclusion and sIRE. Outcomes will be evaluated through internationally validated questionnaires and morbidity scales. All men will undergo a control biopsy at one year. Results: Primary objectives were the evaluation of the safety of sIRE (and patients' quality of life) after treatment. Secondary objectives were the evaluation of functional outcomes, namely, continence and erectile function changes and evaluation of short-term oncological efficacy. Conclusions: SAFE is the second pilot study to evaluate sIRE and the first one performed according to the most recent diagnostic and staging imaging standards. sIRE may provide a curative option for recurrent PCa together with lower comorbidities compared to sRP.

T1G1 Bladder Cancer: Prognosis for this Rare Pathological Diagnosis Within the Non-muscle-invasive Bladder Cancer Spectrum.

BACKGROUND: The pathological existence and clinical consequence of stage T1 grade 1 (T1G1) bladder cancer are the subject of debate. Even though the diagnosis of T1G1 is controversial, several reports have consistently found a prevalence of 2-6% G1 in their T1 series. However, it remains unclear if T1G1 carcinomas have added value as a separate category to predict prognosis within the non-muscle-invasive bladder cancer (NMIBC) spectrum. OBJECTIVE: To evaluate the prognostic value of T1G1 carcinomas compared to TaG1 and T1G2 carcinomas within the NMIBC spectrum. DESIGN, SETTING, AND PARTICIPANTS: Individual patient data for 5170 primary Ta and T1 bladder tumors from 17 hospitals in Europe and Canada were analyzed. Transurethral resection (TUR) was performed between 1990 and 2018. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Time to recurrence and progression were analyzed using cumulative incidence functions, log-rank tests, and multivariable Cox regression models stratified by institution. RESULTS AND LIMITATIONS: T1G1 represented 1.9% (99/5170) of all carcinomas and 5.3% (99/1859) of T1 carcinomas. According to primary TUR dates, the proportion of T1G1 varied between 0.9% and 3.5% per year, with similar percentages in the early and later calendar years. We found no difference in time to recurrence between T1G1 and TaG1 (p = 0.91) or between T1G1 and T1G2 (p = 0.30). Time to progression significantly differed between TaG1 and T1G1 (p < 0.001) but not between T1G1 and T1G2 (p = 0.30). Multivariable analyses for recurrence and progression showed similar results. CONCLUSIONS: The relative prevalence of T1G1 diagnosis was low and remained constant over the past three decades. Time to recurrence of T1G1 NMIBC was comparable to that for other stage/grade NMIBC combinations. Time to progression of T1G1 NMIBC was comparable to that for T1G2 but not for TaG1, suggesting that treatment and surveillance of T1G1 carcinomas should be more like the approaches for T1G2 NMIBC in accordance with the intermediate and/or high risk categories of the European Association of Urology NMIBC guidelines. PATIENT SUMMARY: Although rare, stage T1 grade 1 (T1G1) bladder cancer is still diagnosed in daily clinical practice. Using individual patient data from 17 centers in Europe and Canada, we found that time to progression of T1G1 cancer was comparable to that for T1G2 but not TaG1 cancer. Therefore, our results suggest that primary T1G1 bladder cancers should be managed with more aggressive treatment and more frequent follow-up than for low-risk bladder cancer.

Endoscopic resection of bladder cancer in patients receiving double platelet antiaggregant therapy.

BACKGROUND: Approximately 5% of patients who have undergone coronary artery stenting require noncardiac surgery within a year of their cardiac intervention. European cardiological guidelines and recommendations from the U.S. Food and Drug Administration on platelet antiaggregant therapy following coronary artery stenting are for dual treatment with acetylsalicylic acid and clopidogrel, which should be continued for at least 12 months. The aim of this study was to evaluate the clinical course in patients receiving double platelet antiaggregant therapy who underwent transurethral resection of bladder cancer. METHODS: Between September 2007 and April 2010, twelve patients receiving double antithrombotic therapy (clopidogrel+acetylsalicylic acid) underwent transurethral resection of bladder cancer. In two cases the operation was "urgent". The mean age of the patients was 71.25 years (range, 52-83 years). In nine cases the bladder cancer was newly diagnosed. RESULTS: The patients' preoperative mean hemoglobin concentration was 11.4 g/dl (range=5.2-13.4 g/dl), and on the first postoperative day it was 10.2 g/dl (range=9.6-12.6 g/dl). The mean duration of the intervention was 32 min (range=20-60 min). There were no cardiac complications in either the perioperative or the postoperative period. No patient required reintervention for hemostatic purposes. Three episodes of clot-related acute urinary retention occurred after removal of the bladder catheter, all of which were resolved with replacement of the catheter without needing reintervention. CONCLUSION: Despite the high number of complications related to cardiac problems that suspension of these drugs causes, this urological intervention, carried out during dual antithrombotic therapy, was feasible and without major complications. Given the high proportion of complications due to clot-related urinary retention, it is advisable to leave the urinary catheter in place for a longer period.

Does Vaginal Wall Surgical Trauma During Hybrid Transvaginal NOTES Nephrectomy Have Traumatic Effects On Sexual Functions? A Prospective Study.

BACKGROUND: Surgical trauma due to vaginal wall incision to extract the specimen during transvaginal hybrid Natural-Orifices-Transluminal-Endoscopic-Surgery (NOTES) nephrectomy can result in sexual dysfunction and have traumatic psychological impacts. We evaluated the alteration of sexual functions in the postoperative period. METHODS: Patients who underwent a transvaginal NOTES nephrectomy were prospectively enrolled. Patients and their partners were evaluated with the Golombok-Rust Inventory of Sexual Satisfaction (GRISS) questionnaire pre- and post-operatively. Surgical characteristics were recorded. RESULTS: Fifty-three patients (mean age: 52.72 ± 2.39 years; mean tumor size 4.77 ± 2.55 cm) were included. The total GRISS scores of all patients were similar in pre- and post-operative periods. Although females reported no change in the GRISS score, 60.4% of partners showed a drop in the total score. Non-communication and avoidance subdomains showed significant changes for females; males showed a significant change in avoidance, non-sensuality and dissatisfaction subdomains. Subgroup analyses showed that neither tumor stage nor nulliparous status did not affect total score changes for both genders. The trocar number and perioperative complication rates had no significant effects on total score changes. CONCLUSION: Sexual function can be affected after transvaginal NOTES nephrectomy and care should include a stringent approach to addressing sexual dysfunction. We support the transvaginal NOTES nephrectomy technique if adequate secondary measures to protect sexual function are taken.

European Association of Urology (EAU) Prognostic Factor Risk Groups for Non-muscle-invasive Bladder Cancer (NMIBC) Incorporating the WHO 2004/2016 and WHO 1973 Classification Systems for Grade: An Update from the EAU NMIBC Guidelines Panel.

BACKGROUND: The European Association of Urology (EAU) prognostic factor risk groups for non-muscle-invasive bladder cancer (NMIBC) are used to provide recommendations for patient treatment after transurethral resection of bladder tumor (TURBT). They do not, however, take into account the widely used World Health Organization (WHO) 2004/2016 grading classification and are based on patients treated in the 1980s. OBJECTIVE: To update EAU prognostic factor risk groups using the WHO 1973 and 2004/2016 grading classifications and identify patients with the lowest and highest probabilities of progression. DESIGN, SETTING, AND PARTICIPANTS: Individual patient data for primary NMIBC patients were collected from the institutions of the members of the EAU NMIBC guidelines panel. INTERVENTION: Patients underwent TURBT followed by intravesical instillations at the physician's discretion. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Multivariable Cox proportional-hazards regression models were fitted to the primary endpoint, the time to progression to muscle-invasive disease or distant metastases. Patients were divided into four risk groups: low-, intermediate-, high-, and a new, very high-risk group. The probabilities of progression were estimated using Kaplan-Meier curves. RESULTS AND LIMITATIONS: A total of 3401 patients treated with TURBT ± intravesical chemotherapy were included. From the multivariable analyses, tumor stage, WHO 1973/2004-2016 grade, concomitant carcinoma in situ, number of tumors, tumor size, and age were used to form four risk groups for which the probability of progression at 5 yr varied from <1% to >40%. Limitations include the retrospective collection of data and the lack of central pathology review. CONCLUSIONS: This study provides updated EAU prognostic factor risk groups that can be used to inform patient treatment and follow-up. Incorporating the WHO 2004/2016 and 1973 grading classifications, a new, very high-risk group has been identified for which urologists should be prompt to assess and adapt their therapeutic strategy when necessary. PATIENT SUMMARY: The newly updated European Association of Urology prognostic factor risk groups for non-muscle-invasive bladder cancer provide an improved basis for recommending a patient's treatment and follow-up schedule.