Multi-institutional Retrospective Study of Percutaneous Cholangioscopy-Assisted Lithotripsy for Inoperable Calculous Cholecystitis.

PURPOSE: This study aimed to assess the safety and efficacy of percutaneous lithotripsy for gallstone eradication in patients with calculous cholecystitis with stones >1 cm. MATERIALS AND METHODS: Multi-institutional institutional review board approved retrospective review of patients who presented with calculous cholecystitis and were not determined to be surgical candidates. All patients underwent percutaneous cholecystostomy tube placement for acute infection, which was later exchanged for a large sheath for ShockPulse (Olympus, Tokyo, Japan) lithotripsy and stone destruction. Review parameters included procedural technical and clinical data, including clinical presentation, mean length of hospital stay, and postintervention symptom reduction. RESULTS: Twelve patients (mean age, 74.6 years; range, 52-94 years; 6 men and 6 women) underwent large-bore sheath (24-30 F) cholangioscopy-assisted gallstone destruction via rigid lithotripsy. The size of the gallstones ranged from 1.2 to 4.0 cm. All patients had prior cholecystostomy access for a mean of 25 weeks before gallstone extraction to ensure tract maturation via transhepatic or transperitoneal access. The technical success rate in single-session stone removal was 100%, with no major procedure-related adverse events. All patients were symptom- and pain-free after the procedure. The mean procedure time was 111.5 minutes, and the mean fluoroscopy time was 19.2 minutes. The median length of hospital stay was 1 day after the procedure. The mean time from percutaneous lithotripsy to biliary tube removal was 35 days (range, 17-45 days). CONCLUSIONS: Fluoroscopy-guided percutaneous rigid lithotripsy is a safe and effective procedure for gallstone destruction and extraction in patients who are poor surgical candidates with large lumen-occupying cholelithiasis.

MRI-guided focused ultrasound focal therapy for patients with intermediate-risk prostate cancer: a phase 2b, multicentre study.

BACKGROUND: Men with grade group 2 or 3 prostate cancer are often considered ineligible for active surveillance; some patients with grade group 2 prostate cancer who are managed with active surveillance will have early disease progression requiring radical therapy. This study aimed to investigate whether MRI-guided focused ultrasound focal therapy can safely reduce treatment burden for patients with localised grade group 2 or 3 intermediate-risk prostate cancer. METHODS: In this single-arm, multicentre, phase 2b study conducted at eight health-care centres in the USA, we recruited men aged 50 years and older with unilateral, MRI-visible, primary, intermediate-risk, previously untreated prostate adenocarcinoma (prostate-specific antigen ≤20 ng/mL, grade group 2 or 3; tumour classification ≤T2) confirmed on combined biopsy (combining MRI-targeted and systematic biopsies). MRI-guided focused ultrasound energy, sequentially titrated to temperatures sufficient for tissue ablation (about 60-70°C), was delivered to the index lesion and a planned margin of 5 mm or more of normal tissue, using real-time magnetic resonance thermometry for intraoperative monitoring. Co-primary outcomes were oncological outcomes (absence of grade group 2 and higher cancer in the treated area at 6-month and 24-month combined biopsy; when 24-month biopsy data were not available and grade group 2 or higher cancer had occurred in the treated area at 6 months, the 6-month biopsy results were included in the final analysis) and safety (adverse events up to 24 months) in all patients enrolled in the study. This study is registered with ClinicalTrials.gov, NCT01657942, and is no longer recruiting. FINDINGS: Between May 4, 2017, and Dec 21, 2018, we assessed 194 patients for eligibility and treated 101 patients with MRI-guided focused ultrasound. Median age was 63 years (IQR 58-67) and median concentration of prostate-specific antigen was 5·7 ng/mL (IQR 4·2-7·5). Most cancers were grade group 2 (79 [78%] of 101). At 24 months, 78 (88% [95% CI 79-94]) of 89 men had no evidence of grade group 2 or higher prostate cancer in the treated area. No grade 4 or grade 5 treatment-related adverse events were reported, and only one grade 3 adverse event (urinary tract infection) was reported. There were no treatment-related deaths. INTERPRETATION: 24-month biopsy outcomes show that MRI-guided focused ultrasound focal therapy is safe and effectively treats grade group 2 or 3 prostate cancer. These results support focal therapy for select patients and its use in comparative trials to determine if a tissue-preserving approach is effective in delaying or eliminating the need for radical whole-gland treatment in the long term. FUNDING: Insightec and the National Cancer Institute.

A Deep Learning Approach to Diagnostic Classification of Prostate Cancer Using Pathology-Radiology Fusion.

BACKGROUND: A definitive diagnosis of prostate cancer requires a biopsy to obtain tissue for pathologic analysis, but this is an invasive procedure and is associated with complications. PURPOSE: To develop an artificial intelligence (AI)-based model (named AI-biopsy) for the early diagnosis of prostate cancer using magnetic resonance (MR) images labeled with histopathology information. STUDY TYPE: Retrospective. POPULATION: Magnetic resonance imaging (MRI) data sets from 400 patients with suspected prostate cancer and with histological data (228 acquired in-house and 172 from external publicly available databases). FIELD STRENGTH/SEQUENCE: 1.5 to 3.0 Tesla, T2-weighted image pulse sequences. ASSESSMENT: MR images reviewed and selected by two radiologists (with 6 and 17 years of experience). The patient images were labeled with prostate biopsy including Gleason Score (6 to 10) or Grade Group (1 to 5) and reviewed by one pathologist (with 15 years of experience). Deep learning models were developed to distinguish 1) benign from cancerous tumor and 2) high-risk tumor from low-risk tumor. STATISTICAL TESTS: To evaluate our models, we calculated negative predictive value, positive predictive value, specificity, sensitivity, and accuracy. We also calculated areas under the receiver operating characteristic (ROC) curves (AUCs) and Cohen's kappa. RESULTS: Our computational method (https://github.com/ih-lab/AI-biopsy) achieved AUCs of 0.89 (95% confidence interval [CI]: [0.86-0.92]) and 0.78 (95% CI: [0.74-0.82]) to classify cancer vs. benign and high- vs. low-risk of prostate disease, respectively. DATA CONCLUSION: AI-biopsy provided a data-driven and reproducible way to assess cancer risk from MR images and a personalized strategy to potentially reduce the number of unnecessary biopsies. AI-biopsy highlighted the regions of MR images that contained the predictive features the algorithm used for diagnosis using the class activation map method. It is a fully automatic method with a drag-and-drop web interface (https://ai-biopsy.eipm-research.org) that allows radiologists to review AI-assessed MR images in real time. LEVEL OF EVIDENCE: 1 TECHNICAL EFFICACY STAGE: 2.

Real-world comparative effectiveness of shockwave lithotripsy versus ureterorenoscopy for the treatment of urinary stones.

PURPOSE: To identify clinical and non-clinical predictors of treatment failure and perioperative complications following ureterorenoscopy versus shockwave lithotripsy. METHODS: The New York State Department of Health Statewide Planning and Research Cooperative System (SPARCS) database was used to identify 226,331 patients who underwent index ureteroscopy or shockwave lithotripsy for renal stones from 2000 to 2016. Propensity-matched generalized linear-mixed modeling was utilized to compare failure and complication rates between the two procedure groups. RESULTS: 219,383 individuals meeting inclusion criteria who underwent either ureterorenoscopy (n = 124,342) or shockwave lithotripsy (n = 95,041) in New York State between 2000 and 2016 were included in our analysis. After propensity score matching, patients undergoing shockwave lithotripsy were found to have decreased odds of experiencing any type of 30-day complication (P < 0.001 for all) but increased odds of treatment failure at both 90 (OR 1.70, 95% CI 1.64-1.77) and 180 (OR 1.83, 95% CI 1.76-1.89) days (P < 0.001 for both). CONCLUSION: Patients undergoing shockwave lithotripsy experienced significantly higher odds of treatment failure, although this undesirable outcome appears to be partially offset by lower 30-day complication rates.

Management of the Small Renal Mass: a 2020 Update.

PURPOSE OF REVIEW: Small renal masses (≤ cT1a, less than 4 cm) are a subset of renal tumors with low malignant and metastatic potential but increasing incidence given increased use of cross-sectional imaging. Here, we review the diagnostic and treatment options available for the lesions. RECENT FINDINGS: While the low metastatic potential of SRMs has been known, recent studies show that 30% of SRMs removed surgically are benign. Renal biopsy is a tool that can be implemented to help with diagnosis before treatment (options of which include active surveillance, ablation, and surgery). Active surveillance might be associated with worse cancer-specific survival but all interventional methods appear to fare similarly. Advancements have also been made in percutaneous ablation techniques, and they now are included on multiple guideline statements. Active surveillance, surgery (PN and RN), and thermal ablation are all treatment options for SRMs with similar outcomes but varying side effects.

The Clinical Utility of the Genomic Prostate Score in Men with Very Low to Intermediate Risk Prostate Cancer.

PURPOSE: We retrospectively investigated the Genomic Prostate Score® assay in clinical practice at an urban tertiary care academic center. MATERIALS AND METHODS: We reviewed all Genomic Prostate Score results acquired during a 3-year period. Changes in patient NCCN® (National Comprehensive Cancer Network®) risk group, including very low, low, intermediate or high risk, and ultimate management decisions were recorded. RESULTS: Genomic Prostate Score risk stratification was performed in 134 men. According to the NCCN Guidelines®, 31 of the 134 men (23.1%) were at very low risk, 45 (33.6%) were at low risk and 58 (43.3%) were at intermediate risk. After adding the score the risk group changed in 32 of 134 patients (23.9%). The risk group did not change in the 31 men at very low risk. However, in the low risk group the risk changed in 19 of the 45 men (42.2%), including in 15 to very low and in 4 to intermediate risk. Also, in the intermediate risk group the risk changed in 13 of the 58 men (22.4%), including to low in 12 and to high risk in 1. Nine of the 15 men (60%) in whom risk changed from low to very low elected active surveillance. Nine of the 12 patients (75%) at intermediate risk in whom risk changed to low risk elected active surveillance, 2 (16.7%) elected definitive therapy and in 1 (8.3%) the choice was unknown. Of the 45 men at intermediate risk in whom risk was unchanged 28 (62.2%) elected definitive therapy, 12 (26.0%) elected active surveillance and in 5 (11.1%) the choice was unknown. Of the 4 men upgraded from low to intermediate risk after adding the genomic prostate score 2 elected definitive therapy and 2 chose active surveillance. CONCLUSIONS: The Genomic Prostate Score has limited clinical usefulness in patients at very low risk since the NCCN risk group did not change. While it may be more useful for men at low and intermediate risk, for 32 (31%) of whose risk group was reclassified, clinical management decisions did not always appear to reflect these changes.

Extrahepatic Clinical Application of Vessel Tracking Software and 3D Roadmapping Tools: Preliminary Experience.

This article demonstrates the use of a representative commercially available automated vessel-tracking software originally intended for liver-only application (Vessel Assist Flight Plan for Liver; GE) in 4 patients. Treatment settings included embolization of small bowel hemorrhage source, treatment of renal cell carcinoma, management of symptomatic benign prostate hypertrophy, and detection with subsequent closure of a mesenteric pseudoaneurysm. All patients were treated successfully.

Development of a Nationally Representative Coordinated Registry Network for Prostate Ablation Technologies.

PURPOSE: The accumulation of data through a prospective, multicenter coordinated registry network is a practical way to gather real world evidence on the performance of novel prostate ablation technologies. Urological oncologists, targeted biopsy experts, industry representatives and representatives of the FDA (Food and Drug Administration) convened to discuss the role, feasibility and important data elements of a coordinated registry network to assess new and existing prostate ablation technologies. MATERIALS AND METHODS: A multiround Delphi consensus approach was performed which included the opinion of 15 expert urologists, representatives of the FDA and leadership from high intensity focused ultrasound device manufacturers. Stakeholders provided input in 3 consecutive rounds with conference calls following each round to obtain consensus on remaining items. Participants agreed that these elements initially developed for high intensity focused ultrasound are compatible with other prostate ablation technologies. Coordinated registry network elements were reviewed and supplemented with data elements from the FDA common study metrics. RESULTS: The working group reached consensus on capturing specific patient demographics, treatment details, oncologic outcomes, functional outcomes and complications. Validated health related quality of life questionnaires were selected to capture patient reported outcomes, including the IIEF-5 (International Index of Erectile Function-5), the I-PSS (International Prostate Symptom Score), the EPIC-26 (Expanded Prostate Cancer Index Composite-26) and the MSHQ-EjD (Male Sexual Health Questionnaire for Ejaculatory Dysfunction). Group consensus was to obtain followup multiparametric magnetic resonance imaging and prostate biopsy approximately 12 months after ablation with additional imaging or biopsy performed as clinically indicated. CONCLUSIONS: A national prostate ablation coordinated registry network brings forth vital practice pattern and outcomes data for this emerging treatment paradigm in the United States. Our multiple stakeholder consensus identifies critical elements to evaluate new and existing energy modalities and devices.

Partial Gland Treatment of Prostate Cancer Using High-Intensity Focused Ultrasound in the Primary and Salvage Settings: A Systematic Review.

PURPOSE: Advances in prostate imaging, biopsy and ablative technologies have been accompanied by growing enthusiasm for partial gland ablation, particularly using high-intensity focused ultrasound, to treat prostate cancer. Preserving noncancerous prostate tissue and minimizing damage to the neurovascular bundles and external urethral sphincter may improve functional outcomes. MATERIALS AND METHODS: A systematic review was performed following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines using a combination of MeSH® terms, free text search and examination of relevant bibliographies using MEDLINE® and Embase® from the inception of each database through October 10, 2016. We excluded studies describing exclusively whole gland ablation, case reports and series where treatment was followed by immediate resection. RESULTS: A total of 13 studies that enrolled 543 patients were included. Of the studies 11 were performed in the primary setting and 2 in the salvage setting. Median followup ranged from 6 months to 10.6 years. Rates of posttreatment erectile dysfunction and urinary incontinence ranged from 0% to 48% and 0% to 50%, respectively, with definitions varying by study. Overall there were 254 reported complications. Marked heterogeneity between studies limited the ability to pool results regarding functional and oncologic outcomes. A total of 76 patients (14%) subsequently received further oncologic treatment. CONCLUSIONS: Early evidence suggests that partial gland ablation is a safe treatment option for men with localized disease. Longer term data are needed to evaluate oncologic efficacy and functional outcomes, and will aid in identifying the optimal candidates for therapy. Standardization of outcomes definitions will allow for better comparison between studies and among treatment modalities.

Partial gland ablation in the management of prostate cancer: a review.

PURPOSE OF REVIEW: The index lesion theory has created a strong interest in partial gland ablation for men with prostate cancer. By only treating the focus of clinically significant disease and avoidance of surrounding periprostatic tissue, one may provide adequate oncologic control with minimal side effects. Accurate identification of the index lesion and effective ablation are critical for satisfactory oncologic outcomes. Herein, we review key ablative techniques used in partial gland ablation. RECENT FINDINGS: Increasing accuracy in identifying localized prostate cancer enabled the emergence of partial gland ablation, which appears to have acceptable short-term oncologic control with minimal side effects. Cryoablation, high-intensity focused ultrasound, focal laser ablation, and irreversible electroporation are emerging technologies that are demonstrating their utility in partial gland ablation. These different ablative techniques offer unique advantages and drawbacks in partial gland ablation of prostate cancer. SUMMARY: Prostate imaging continues to scale the challenge of accurately identifying clinically significant prostate cancer. Ablative techniques demonstrate acceptable short-term oncologic outcomes but will require longer follow-up to determine true oncologic efficacy. There are no randomized trial comparisons to conventional radical prostatectomy or radiotherapy, and there is limited oncologic follow-up beyond 5 years. The type of ablation technique used will likely depend on many factors such as tumor volume, tumor location, and patient characteristics. Oncologic efficacy, health-related quality of life, and advantages and limitations of each technique will be reviewed.

Role of prostate artery embolization in the management of refractory haematuria of prostatic origin.

Prostatic haematuria is among the most common genitourinary complaints of emergency room visits, distressing and troublesome to men and a challenging clinical problem to the treating physician. The most common aetiologies of prostatic haematuria include benign prostatic hyperplasia and prostate cancer. Prostatic haematuria usually resolves with conservative and medical methods; failure of these interventions results in refractory haematuria of prostatic origin (RHPO), a potentially life-threatening scenario. Several different treatments have been described, with varying degrees of success. Patients with RHPO are often elderly and unfit for radical surgery. Prostate artery embolization (PAE) has evolved as a safe and effective technique in the management of RHPO. Use of a superselective approach optimizes clinical success while minimizing complications. This minimally invasive approach improves patients with haemodynamic instability, serves as a bridge to elective surgery, and is a highly effective treatment for RHPO. It may obviate the need for more invasive and morbid surgical therapies. The aim of the present review was to describe the current management of RHPO and the technique of PAE and to review its efficacy and associated morbidity.

Intermediate outcomes and predictors of efficacy in the radiofrequency ablation of 100 pathologically proven renal cell carcinomas.

PURPOSE: To determine oncologic outcomes and predictors of primary efficacy, including RENAL nephrometry scores (radius, exophytic/endophytic properties, nearness of tumor to collecting system or sinus, anterior/posterior, location relative to polar lines), after percutaneous radiofrequency (RF) ablation of proven renal cell carcinoma (RCC). MATERIALS AND METHODS: Patients who underwent percutaneous computed tomography- and ultrasound-guided RF ablation for histologically proven RCC from 2004 to 2011 were evaluated. Clinical data, pathologic findings, technical details, and outcomes were reviewed. Univariate and multivariate logistic regression analysis was performed to determine predictors of primary technique effectiveness and complications. Local tumor progression-free, metastasis-free, and overall survival were calculated. One hundred RCC lesions underwent 115 RF ablation sessions in 84 patients. Median follow-up was 24 months (mean, 27 mo; range, 1-106 mo). RESULTS: Efficacy of RF ablation was defined per International Working Group of Image-Guided Tumor Ablation criteria. Total, primary, and secondary technique effectiveness rates were 95% (95 of 100), 86% (86 of 100), and 9% (nine of 100), respectively. Primary efficacy was associated with size (P < .001), proximity to collecting system (P = .001), RENAL nephrometry score (P < .001), and number of ablation zones (P < .001). Complications occurred in 13% of patients, without procedure-related deaths. The median 2.1-year local progression-free, metastasis-free, disease-specific, and overall survival rates were 86%, 98.7%, 100%, and 97.6%, respectively. CONCLUSIONS: Percutaneous image-guided RF ablation for RCC provides excellent intermediate oncologic control. Location, size, proximity to the collecting system, low RENAL nephrometry score, and number of ablation zones predict primary efficacy.

Comparative Effectiveness of Partial Gland Cryoablation Versus Robotic Radical Prostatectomy for Cancer Control.

BACKGROUND AND OBJECTIVE: There is an absence of high-level evidence comparing oncologic endpoints for partial gland ablation, and most series use prostate-specific antigen (PSA) rather than biopsy endpoints. Our aim was to compare oncologic outcomes between partial gland cryoablation (PGC) and radical prostatectomy (RP) for prostate cancer. METHODS: This was a retrospective, single-center analysis of subjects treated with PGC (n = 98) or RP (n = 536) between January 2017 and December 2022 as primary treatment for intermediate-risk (Gleason grade group [GG] 2-3) prostate cancer. Oncologic endpoints included surveillance biopsies per protocol after PGC in comparison to serial PSA testing after RP. The primary outcome was treatment failure, defined as a need for any salvage treatment or development of metastatic disease. Treatment failure and survival analyses were conducted using Cox proportional-hazard regression and Kaplan Meier survival curves. KEY FINDINGS AND LIMITATIONS: After applying the inclusion/exclusion criteria, the PGC (n = 75) and RP (n = 298) groups were compared. PGC patients were significantly older (71 vs 64 yr; p < 0.001), but there were no differences in PSA, biopsy GG, or treatment year between the groups. The PGC group had higher rates of treatment failures at 24 mo (33% vs 11%; p < 0.001) and 48 mo (43% vs 14%; p < 0.001). One PGC patient (2.1%) and one RP patient (0.7%) developed metastases by 48-mo follow-up (p = 0.4). On adjusted analysis, PGC was associated with a higher risk of treatment failure (hazard ratio 4.6, 95% confidence interval 2.7-7.9; p < 0.001). Limitations include observational biases associated with the retrospective study design. CONCLUSIONS: This is the first comparative effectiveness study of cancer control outcomes for PGC versus RP. The results demonstrate an almost fivefold higher risk of treatment failure with PGC during short-term follow-up. PATIENT SUMMARY: We compared cancer control outcomes for patients with intermediate-risk prostate cancer treated with partial gland cryoablation versus radical prostatectomy. We found that partial gland cryoablation had an almost fivefold higher risk of treatment failure. Men with prostate cancer should be counseled regarding this difference in treatment failure.