Accuracy, safety, and diagnostic prediction of percutaneous renal mass biopsy and subsequent changes in treatment.

Introduction: The incidence of renal tumours is increasing annually, and imaging alone cannot meet the diagnostic needs. Aim: This single-centre study aimed to evaluate the predictors of diagnostic imaging-guided percutaneous renal mass biopsy (PRMB), its accuracy and safety, and subsequent changes to the treatment plan. Material and methods: We retrospectively collected the clinical data of patients who had undergone PRMB. The diagnosis rate, pathological data, and complications were analysed. Potential predictors of a diagnostic PRMB were evaluated using logistic regression analysis. Changes to the treatment plan due to PRMB results were also analysed. Results: A total of 158 patients were included in this study. The univariate analysis showed that higher tumour diameter (OR = 1.223, 95% CI: 1.018-1.468, p = 0.031) and number of biopsy cores ≥ 2 (OR = 6.125, 95% CI: 2.006-18.703, p = 0.001) were significantly associated with diagnostic biopsy, and multivariate analysis results showed that higher tumour diameter (OR = 1.215, 95% CI: 1.008-1.463, p = 0.041) was an independent predictor of diagnostic biopsy. A nomogram including tumour diameter and number of biopsy cores was constructed to predict diagnostic biopsy. Compared with postoperative pathology, the concordance between biopsy and postoperative pathology at identifying malignancies, histologic type, and histologic grade were 100% (47/47), 85.1% (40/47), and 54.1% (20/37), respectively. The treatment plans of 15 patients (9.5%) changed based on the PRMB results. Fourteen patients (8.9%) had minor complications (Clavien-Dindo classification < 2). Conclusions: Our results suggest that tumour diameter was an independent predictor of diagnostic biopsy. Furthermore, PRMB can be accurately and safely performed and may guide clinical decision-making for patients with renal tumours.

Clear cell likelihood score may improve diagnosis and management of renal masses.

The detection of solid renal masses has increased over time due to incidental findings during imaging studies conducted for unrelated medical conditions. Approximately 20% of lesions measuring less than 4 cm are benign and 80% are malignant. Clear cell renal cell carcinoma (ccRCC) is the most frequent among renal carcinomas, responsible for 65-80% of cases. The increased detection of renal masses facilitates early diagnosis and treatment. However, it also leads to more invasive interventions, which result in higher morbidity and costs. Currently, only histological analysis can offer an accurate diagnosis. Surgical nephron loss significantly elevates morbidity and mortality rates. Active surveillance represents a conservative management approach for patients diagnosed with a solid renal mass that is endorsed by both American Urological Association and the European Society for Medical Oncology. However, active surveillance is used in a minority of patients and varies across institutions. The lack of clinical studies using a standardized approach to incidentally detected small renal masses precludes the widespread use of active surveillance. Hence, there is an urgent need for better patient selection, distinguishing those who require surgery from those suitable for active surveillance. The clear cell likelihood score (ccLS) represents a novel MRI tool for assessing the probability of a renal mass being a ccRCC. In this study, we present a comprehensive review of renal masses and their evaluation using the ccLS to facilitate shared decision between urologists and patients.

The Metastatic Risk of Renal Cell Carcinoma by Primary Tumor Size and Subtype.

Background: Current data on the association between tumor size, subtype, and metastases, and thresholds for intervention, for renal cell carcinoma (RCC), are largely based on single-center nephrectomy registries that may under-represent those presenting with metastatic disease. Objective: We sought to assess tumor size and histologic subtype in relation to metastatic status at presentation for patients with RCC. Design setting and participants: Using Surveillance, Epidemiology and End Results cancer registry data, we identified patients with a diagnosis of RCC made between 2004 and 2019, and a known size of primary tumor. We used nodal and metastatic TNM staging to assess metastatic disease at presentation. Outcome measurements and statistical analysis: We report the proportion of metastatic disease across varying tumor sizes for clear cell (ccRCC), papillary (pRCC), and chromophobe (chRCC) RCC. We also examine sarcomatoid RCC and RCC with sarcomatoid features (sarcRCC). Logistic regression models were used to model the likelihood of metastatic disease for each histologic subtype. Results and limitations: Of 181 096 RCC patients included, 23 829 had metastatic disease. For any RCC, metastatic rates of 3.6%, 13.1%, 30.3%, and 45.1% were observed for tumors ≤4, 4-≤7, 7-≤10, and >10 cm, respectively. Metastatic rates of chRCC were low at even large sizes, 11.0% at >10 cm. In contrast, sarcRCC had high metastatic rates at all sizes, 27.1% at ≤4 cm. Metastatic rates for ccRCC and pRCC increased steadily above 3 cm. For any RCC and each evaluated subtype, tumor size was found to be associated with metastatic disease on logistic regression (p < 0.001). Conclusions: The likelihood of a renal mass being metastatic varies greatly with both its subtype and size. We report higher likelihoods of metastatic disease across tumor sizes compared with what has been reported previously. These results may help clinicians pick appropriate thresholds for intervention and candidates for active surveillance. Patient summary: We find that the metastatic probability of renal cell carcinoma varies greatly with subtype and increases with tumor size.

Stimulated Raman histology as a method to determine the adequacy of renal mass biopsy and identify malignant subtypes of renal cell carcinoma.

INTRODUCTION: Renal tumor biopsy requires adequate tissue sampling to aid in the investigation of small renal masses. In some centers the contemporary nondiagnostic renal mass biopsy rate may be as high as 22% and may be as high as 42% in challenging cases. Stimulated Raman Histology (SRH) is a novel microscopic technique which has created the possibility for rapid, label-free, high-resolution images of unprocessed tissue which may be viewed on standard radiology viewing platforms. The application of SRH to renal biopsy may provide the benefits of routine pathologic evaluation during the procedure, thereby reducing nondiagnostic results. We conducted a pilot feasibility study, to assess if renal cell carcinoma (RCC) subtypes may be imaged and to see if high-quality hematoxylin and eosin (H&E) could subsequently be generated. METHODS/MATERIALS: An 18-gauge core needle biopsy was taken from a series of 25 ex vivo radical or partial nephrectomy specimens. Histologic images of the fresh, unstained biopsy samples were obtained using a SRH microscope using 2 Raman shifts: 2,845 cm-1 and 2,930 cm-1. The cores were then processed as per routine pathologic protocols. The SRH images and hematoxylin and eosin (H&E) slides were then viewed by a genitourinary pathologist. RESULTS: The SRH microscope took 8 to 11 minutes to produce high-quality images of the renal biopsies. Total of 25 renal tumors including 1 oncocytoma, 3 chromophobe RCC, 16 clear cells RCC, 4 papillary RCC, and 1 medullary RCC were included. All renal tumor subtypes were captured, and the SRH images were easily differentiated from adjacent normal renal parenchyma. High quality H&E slides were produced from each of the renal biopsies after SRH was completed. Immunostains were performed on selected cases and the staining was not affected by the SRH image process. CONCLUSION: SRH produces high quality images of all renal cell subtypes that can be rapidly produced and easily interpreted to determine renal mass biopsy adequacy, and on occasion, may allow renal tumor subtype identification. Renal biopsies remained available to produce high quality H&E slides and immunostains for confirmation of diagnosis. Procedural application has promise to decrease the known rate of renal mass nondiagnostic biopsies, and application of convolutional neural network methodology may further improve diagnostic capability and increase utilization of renal mass biopsy among urologists.

Complications After Renal Mass Biopsy: Frequency, Nature, Timing, and Associated Characteristics.

BACKGROUND. Observation periods after renal mass biopsy (RMB) range from 1 hour to overnight hospitalization. Short observation may improve efficiency by allowing use of the same recovery bed and other resources for RMBs in additional patients. OBJECTIVE. The purpose of this study was to evaluate the frequency, timing, and nature of complications after RMB, as well as to identify characteristics associated with such complications. METHODS. This retrospective study included 576 patients (mean age, 64.9 years; 345 men, 231 women) who underwent percutaneous ultrasound- or CT-guided RMB at one of three hospitals, performed by 22 radiologists, between January 1, 2008, and June 1, 2020. The EHR was reviewed to identify postbiopsy complications, which were classified as bleeding-related or non-bleeding-related and as acute (< 24 hours), subacute (24 hours to 30 days), or delayed (> 30 days). Deviations from normal clinical management (analgesia, unplanned laboratory testing, or additional imaging) were identified. RESULTS. Acute and subacute complications occurred after 3.6% (21/576) and 0.7% (4/576) of RMBs, respectively. No delayed complication or patient death occurred. A total of 76.2% (16/21) of acute complications were bleeding-related. A deviation from normal clinical management occurred after 1.6% (9/551) of RMBs that had no associated postbiopsy complication. Among the 16 patients with bleeding-related acute complications, all experienced a deviation, with mean time to deviation of 56 ± 47 (SD) minutes (range, 10-162 minutes; ≤ 120 minutes in 13/16 patients). The five non-bleeding-related acute complications all presented at the time of RMB completion. The four subacute complications occurred from 28 hours to 18 days after RMB. Patients with, versus those without, a bleeding-related complication had a lower platelet count (mean, 197.7 vs 250.4 × 109/L, p = .01) and greater frequency of entirely endophytic renal masses (47.4% vs 19.6%, p = .01). CONCLUSION. Complications after RMB were uncommon and presented either within 3 hours after biopsy or more than 24 hours after biopsy. CLINICAL IMPACT. A 3-hour monitoring window after RMB before patient discharge (in the absence of deviation from normal clinical management and complemented by informing patients of the low risk of a subacute complication) may provide both safe patient management and appropriate resource utilization.

Oncocytoma on renal mass biopsy: is it still the same histology when surgery is performed? Results from UroCCR-104 study.

PURPOSE: To describe clinical features of patients with oncocytoma on renal biopsy (RMB), correlation with final histology on surgically treated patients, and predictive factors of discrepancy between RMB and final histology. METHODS: This was a retrospective study conducted in the framework of the UroCCR project (NCT03293563). All tumors with oncocytoma on RMB were selected and all pathological reports were reviewed. Patients with the RMB simultaneously performed with a focal treatment, synchronous bilateral tumors and ambiguous RMB report were excluded. Discrepancy between RMB and definitive histology was evaluated using a uni- and multivariable logistic regression analyses model. RESULTS: Overall, 119 tumors with oncocytoma on RMB, from 15 centers, were included. Of those, 54 (45.4%) had upfront surgery and 65 (54.6%) had active surveillance (AS). In renal masses with initial active surveillance, with a median follow-up of 28 months, 23 (19.3%) underwent surgery, 4 (3.4%) received focal treatment and 38 (31.9%) remained on AS. On final pathology, only 51 of the 75 surgically treated tumors (68.0%) had oncocytoma, while 24 presented malignant tumors (mainly chromophobe carcinoma (19.2%), and hybrid oncocytic/chromophobe tumor (HOCT) (6.8%)) leading to a discrepancy of 32.0% between RMB and final pathology. The only predictive factor of a discrepancy between RMB and definitive histology was a biopsy done outside of the center (Odds ratio: 3.22 [95%-confidence interval: 1.08-9.61], p = 0.03). CONCLUSION: Despite the increase of RMB in more and more centers, histologic discrepancy between RMB and definitive histology remains significant. This information should be discussed with patients and taken into consideration before treatment decision.

Urine Molecular Biomarkers for Detection and Follow-Up of Small Renal Masses.

Active surveillance (AS) is the best strategy for small renal masses (SRMs) management; however, reliable methods for early detection and disease aggressiveness prediction are urgently needed. The aim of the present study was to validate DNA methylation biomarkers for non-invasive SRM detection and prognosis. The levels of methylated genes TFAP2B, TAC1, PCDH8, ZNF677, FLRT2, and FBN2 were evaluated in 165 serial urine samples prospectively collected from 39 patients diagnosed with SRM, specifically renal cell carcinoma (RCC), before and during the AS via quantitative methylation-specific polymerase chain reaction. Voided urine samples from 92 asymptomatic volunteers were used as the control. Significantly higher methylated TFAP2B, TAC1, PCDH8, ZNF677, and FLRT2 levels and/or frequencies were detected in SRM patients' urine samples as compared to the control. The highest diagnostic power (AUC = 0.74) was observed for the four biomarkers panel with 92% sensitivity and 52% specificity. Methylated PCDH8 level positively correlated with SRM size at diagnosis, while TFAP2B had the opposite effect and was related to SRM progression. To sum up, SRMs contribute significantly to the amount of methylated DNA detectable in urine, which might be used for very early RCC detection. Moreover, PCDH8 and TFAP2B methylation have the potential to be prognostic biomarkers for SRMs.

Ultrasound-Guided Renal Mass Biopsy and Its Clinical Utility: A Single-Centre Experience.

INTRODUCTION: Renal mass biopsy (RMB) is still underutilized, partially because many urologists argue that it does not substantially influence the management of renal masses. We sought to evaluate the influence of RMB on the management of renal tumours in our institution. MATERIALS AND METHODS: A total of 387 RMBs performed at our institution from January 2016 to June 2020 were included. Patient demographics, mass size, biopsy result, and subsequent clinical management were retrospectively reviewed. RESULTS: The mean mass size was 47.8 mm. Fifty-six percentage of tumours ≤40 mm (247) and 8% of tumours >40 mm (64) were biopsied. Seventy-six RMBs of disseminated tumours were performed. 14.9% of RMBs were non-diagnostic, and 27.1% of RMBs of tumours ≤40 mm were benign. The majority of tumours with first non-diagnostic RMB followed by histopathological verification were found to be malignant. There was significantly more conservative management and no radical nephrectomies in the benign biopsy group. One case of Clavien-Dindo grade ≥2 complication occurred. CONCLUSIONS: RMB result affects treatment decisions. Ultrasound-guided RMB is a safe procedure, and performing biopsies of tumours ≤40 mm may reduce the number of unnecessary interventions. Non-diagnostic RMBs should be repeated or treated as malignant.

Multidisciplinary Approach and Outcomes of Pretreatment Small (cT1a) Renal Mass Biopsy: Single-Center Experience.

Purpose: We evaluated our experience of a multidisciplinary approach to renal mass biopsy (RMB) for small renal masses (SRMs) employing in-office ultrasound (US)-guided biopsy by urology (24%), CT, or US biopsy by interventional radiology (IR) (79%), and endoscopic ultrasound (EUS)-guided biopsy by gastroenterology (GI) (4%). Materials and Methods: A single-institution retrospective review of patients who underwent RMB for SRM from May 2013 to August 2019 was conducted. Data regarding patient demographics, tumor characteristics, biopsy technique, histopathology, and management were collected. Diagnostic rates, concordance with final pathology, complications, and outcomes were analyzed. Results: Of the 192 biopsies reviewed, 63% biopsies were malignant, 20% were benign, and 17% were nondiagnostic. Based on biopsy results, 71 patients (37%) elected active surveillance. Thirty-eight (20%) patients underwent cryoablation, 56 (29%) underwent partial nephrectomy, 14 (7%) underwent radical nephrectomy, and the remaining patients were treated elsewhere. The rate of surgery for benign pathology after pretreatment RMB was 3%. The concordance rate between biopsy and final pathology was 99% for malignancy, 96% for specific pathology subtype, and 85% for renal cell carcinoma grade. Median time from diagnosis to definitive treatment was 97 days (urology: 76, IR: 110 and GI: 54, p = 0.002). Three (1.6%) Clavien I complications were reported. Conclusion: Our multidisciplinary approach to RMB for clinical stage T1a demonstrated favorable safety and diagnostic rates, which effectively directed management strategies and minimized surgery for benign disease. Urologist-performed office biopsies significantly shortened the time from diagnosis to definitive treatment. Our experience with GI EUS biopsy has demonstrated feasibility and safety for tumors that were otherwise not accessible percutaneously.

Utilization of Renal Mass Biopsy for T1 Renal Lesions across Michigan: Results from MUSIC-KIDNEY, A Statewide Quality Improvement Collaborative.

BACKGROUND: Renal mass biopsy (RMB) has had limited and varied utilization to guide management of renal masses (RM). OBJECTIVE: To evaluate utilization of RMB for newly diagnosed cT1 RMs across diverse practice types and assess associations of outcomes with RMB. DESIGN SETTING AND PARTICIPANTS: MUSIC-KIDNEY commenced data collection in September 2017 for all newly presenting patients with a cT1 RM at 14 diverse practices. Patients were assessed at ≥120 d after initial evaluation. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Demographics and outcomes were compared for patients undergoing RMB versus no RMB. Clinical and demographic characteristics were summarized by RMB status using a χ2 test for categorical variables and Student t test for continuous variables. A mixed-effects logistic regression model was constructed to identify associations with RMB receipt. RESULTS AND LIMITATIONS: RMB was performed in 15.5% (n = 282) of 1808 patients with a cT1 RM. Practice level rates varied from 0% to 100% (p = 0.001), with only five of 14 practices using RMB in >20% of patients. On multivariate analysis, predictors of RMB included greater comorbidity (Charlson comorbidity index ≥2 vs 0: odds ratio [OR] 1.44; p = 0.025) and solid lesion type (cystic vs solid: OR 0.17; p = 0.001; indeterminate vs solid: OR 0.58; p = 0.01). RMB patients were less likely to have benign pathology at intervention (5.0% vs 13.5%; p = 0.01). No radical nephrectomies were performed for patients with benign histology at RMB. The limitations include short follow-up and inclusion of practices with low numbers of RMBs. CONCLUSIONS: Utilization of RMB varied widely across practices. Factors associated with RMB include comorbidities and lesion type. Patients undergoing RMB were less likely to have benign histology at intervention. PATIENT SUMMARY: Current use of biopsy for kidney tumors is low and varies across our collaborative. Biopsy was performed in patients with greater comorbidity (more additional medical conditions) and for solid kidney tumors. Pretreatment biopsy is associated with lower nonmalignant pathology detected at treatment.

Office-Based Renal Tumor Biopsy: a Paradigm Change in the Management of a Small Renal Mass?

PURPOSE OF REVIEW: The goal of this paper is to evaluate the use of an office-based renal mass biopsy (RMB), whose feasibility could represent a paradigm shift in clinical practice. RECENT FINDINGS: Despite the earlier diagnosis of patients with renal masses, the lack of evidence showing a reduction in cancer-specific mortality warrants an examination in treatment practices. RMB is underutilized when compared to biopsy practice for all other neoplasms in every other solid organ (except testis), and the majority of RMB performed are outsourced to interventional radiologists. Performing an ultrasound-guided, office-based RMB is safe, reproducible, and has a meaningful impact on management decisions. The use of percutaneous RMB in clinical practice is growing, and the use of RMB has meaningful impact on management decisions for renal masses. Incorporating ultrasound-guided biopsy of a renal mass into clinical practice is feasible, and in contemporary practice, the urologist has the skill set to perform the procedure reliably, with low morbidity, and with minimal patient discomfort.

Renal mass biopsy: A strategy to reduce associated costs and morbidity when managing localized renal masses.

INTRODUCTION AND OBJECTIVES: Renal mass biopsy (RMB) has not been widely adopted in evaluating small renal mass due to concerns for safety, efficacy, and its perceived lack of consequence on management decisions. We assess the potential cost savings and morbidity avoidance of routine RMB on cT1 renal masses undergoing robotic-assisted partial nephrectomy (RAPN). METHODS: We identified n = 920 consecutive RAPN pT1 renal masses and n = 429 consecutive RMBs for cT1 renal masses over 12 years. Using a novel pathological-based risk classification system for cT1 renal masses, we evaluated the morbidity and costs of our RAPN and RMB cohorts. We then define four clinical scenarios where RMB could potentially delay and/or avoid intervention in our pT1 RAPN cohort and model potential complications prevented and cost savings utilizing common clinical scenarios. RESULTS: Using our risk stratification system in RAPN patients, final histology was classified as benign in n=174 (18.9%) cases, very low-risk (n = 62 [7%]), low-risk (n = 383 [42%]), and high-risk (n = 301 [33%]), respectively. We identified n = 116 (12.6%) Clavien graded peri-operative complications. In our RMB patients, 120 (27.9%), 17 (3.9%), 240 (55.9%), 52(12.1%) were benign, very low, low and high-risk tumors. The median total direct cost for RAPN was $6955/case compared to $1312/case for RMB. If we established a primary goal to avoid immediate extirpative surgery in benign renal tumors, in the elderly (>70 y) with very low-risk tumors and/or those with high renal functional risks (≥ CKD3b), or competing risks (ASA ≥ 3), RMB could have reduced direct costs by approximately 20% and avoided n = 39 Clavien graded complications, seven readmissions, three transfusions, and two returns to the OR. With the additional cost of performing RMB on those not initially biopsied, the net cost saving would be approximately $1.2 million with minimal added complications while still treating high-risk tumors. CONCLUSIONS: Routine RMB before intervention results in cost-saving and complication avoidance. Given the limitations of biopsy, shared decision-making is mandatory. Biopsy should be considered prior to intervention in at-risk populations.

Diagnostic renal mass biopsy is associated with individual categories of PADUA and RENAL nephrometry scores: Analysis of diagnostic and concordance rates with surgical resection.

BACKGROUND: Renal mass biopsy (RMB) is a safe and accurate method for diagnosis and clinical management of renal masses. However, the non-diagnostic rate is a limiting factor. We tested the hypothesis that imaging characteristics and anatomic complexity of the mass may impact RMB diagnostic outcome using the preoperative aspects and dimensions used for an anatomical (PADUA) classification and radius-exophytic/endophytic-nearness-anterior/posterior-location (RENAL) score. MATERIAL AND METHODS: Single institution, retrospective study of 490 renal masses from 443 patients collected from 2001 to 2018. Outcome measurements include (1) diagnostic and concordance rates amongst RMB types and RMB with surgical resection specimens; (2) association between diagnostic RMB and anatomical complexity of renal masses. The analysis was conducted in unselected masses and small renal masses (SRMs). RESULTS: RMB was performed by fine needle aspiration (FNA), core needle biopsy (CNB), or both (FNA+CNB). Non-diagnostic rate was significantly higher for FNA compared to CNB and FNA+CNB in both unselected and SRMs. Subset analysis in the FNA+CNB group showed similar diagnostic rates for FNA and CNB. In unselected masses, specificity for FNA, CNB, and FNA+CNB was 100%. Sensitivity was higher for CNB (90.1%, P = 0.002) and FNA+CNB (96.3%, P = 0.004) compared to FNA (66.7%). For unselected masses, endophytic growth predicted a non-diagnostic CNB. R.E.N.A.L location entirely between the polar lines (central) and entirely above the upper polar line predicted a diagnostic CNB. Sonography-guidance predicted a diagnostic FNA. For SRMs, non-diagnostic CNB was associated with endophytic growth, while diagnostic CNB was associated with renal sinus invasion and operator experience. More cystic masses were sampled by FNA, but diagnostic results were similar for FNA and CNB. CONCLUSIONS: Endophytic growth consistently predicted a non-diagnostic CNB in unselected and SRMs, whereas sonography-guidance predicted a diagnostic FNA. Cystic masses could be adequately sampled by FNA.

Computed tomography-guided biopsy for small renal masses before or immediately after tumor ablation: factors affecting diagnostic yield.

PURPOSE: To evaluate the diagnostic yield of percutaneous renal mass biopsy (RMB) before and after ablation. MATERIALS AND METHODS: In total, 333 renal masses in 332 consecutive patients underwent computed tomography (CT)-guided biopsies and were included in this study. All biopsies were performed with 18-gauge core needles with CT fluoroscopic guidance before ablation (n = 234) or immediately after radiofrequency ablation (RFA) (n = 40) or cryoablation (CA) (n = 59). The safety and diagnostic yield of RMB were evaluated. Both univariate and multivariate analyses were used to identify factors affecting diagnostic yield. RESULTS: No major complication occurred. The 281 specimens (84%) were diagnostic. There were 257 renal cell carcinomas (77%), 21 benign masses (6%), and 3 metastases (1%). The remaining 52 specimens (16%) were nondiagnostic. The diagnostic yields before ablation, after RFA, and CA were 91% (212/234), 80% (32/40), and 63% (37/59), respectively. Small masses (P = 0.050 and 0.006), cystic masses (P < 0.001 and < 0.001), and post-CA (P < 0.001 and < 0.001) were independent and significant factors affecting the nondiagnostic results in both univariate and multivariate analyses. CONCLUSION: CT-guided RMB can be nondiagnostic when the tumor is small, cystic, or biopsied immediately after CA.

Cost-effectiveness Analysis of 99mTc-sestamibi SPECT/CT to Guide Management of Small Renal Masses.

BACKGROUND: Incidentally detected small renal masses (SRMs) may be one of several benign or malignant tumor histologies, and are heterogeneous in oncologic potential. Renal mass biopsy can be used to determine the histology of SRMs. However, this invasive approach has significant limitations. Technetium-99m sestamibi single photon emission computed tomography/computed tomography (99mTc-sestamibi SPECT/CT) is a promising imaging tool that can aid in identifying benign renal oncocytomas and hybrid oncocytic/chromophobe tumors. OBJECTIVE: To evaluate the clinical and economic value of 99mTc-sestamibi SPECT/CT in guiding the management of SRMs. DESIGN, SETTING, AND PARTICIPANTS: We developed a decision analysis model to estimate the costs and health outcomes of competing management strategies for a healthy 65-yr-old patient with an asymptomatic SRM. INTERVENTION: Empiric surgery (reference); real-world clinical practice (RWCP) consisting of empiric surgery, thermal ablation, and active surveillance (alternative reference); renal mass biopsy (option 1); 99mTc-sestamibi SPECT/CT (option 2); and 99mTc-sestamibi SPECT/CT followed by biopsy to confirm benign SRMs (option 3). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We assessed lifetime health utilities, measured in quality-adjusted life years (QALYs), and direct medical costs from a health payer perspective. We calculated the incremental cost-effectiveness ratio (ICER) for options 1-3 versus the reference and alternative reference arms, with a willingness-to-pay threshold of $50 000/QALY. Univariate, multivariate, and probabilistic sensitivity analyses were performed. RESULTS AND LIMITATIONS: Option 3 had a very low risk of untreated malignant tumors (0.2%, vs 2.1% for option 1, 4.2% for option 2, and 0% for empiric surgery) and the highest probability of leaving benign tumors untreated (84.4%, vs 53.9% for option 1, 51.7% for option 2, and 0% for empiric surgery). Option 3 dominated empiric surgery and options 1 and 2 (ie, lower costs and higher QALYs). Compared with RWCP, options 1-3 were all cost effective; option 3 had the lowest ICER of $18 821/QALY. These findings were robust to alternative input values. Study limitations included data uncertainties and a limited number of centers from which 99mTc-sestamibi SPECT/CT performance data were collected. CONCLUSIONS: 99mTc-sestamibi SPECT/CT followed by confirmatory biopsy helps avoid surgery for benign SRMs, minimizes untreated malignant SRMs, and is cost effective compared with existing strategies. PATIENT SUMMARY: Our research suggests that by using a noninvasive imaging test, known as technetium-99m sestamibi single photon emission computed tomography/computed tomography, to diagnose small renal masses, urologists may avoid unnecessary surgery for benign tumors and minimize the risk of leaving a malignant tumor untreated. Moreover, the use of this strategy to diagnose small renal masses is cost effective for the health care system.

Renal biopsies performed before versus during ablation of T1 renal tumors: implications for prevention of overtreatment and follow-up.

PURPOSE: To assess the difference between renal mass biopsy (RMB) performed either before or during the ablation procedure. METHODS: A retrospective multicenter study was performed in patients with a cT1 renal mass treated with ablation between January 2007 and July 2019, including a search in the national pathology database for patients with a RMB planned for ablation. Patient and tumor characteristics and information on malignant, benign, and non-diagnostic biopsy results were collected to establish rates of overtreatment and number of ablations avoided in case of benign or non-diagnostic histology. RESULTS: RMB was performed in 714 patients, of which 231 patients received biopsy before planned ablation, and 483 patients at the time of ablation. Pathology results before ablation were malignant in 63% (145/231), benign in 20% (46/231) and non-diagnostic in 17% (40/231). Pathology results at the time of ablation were malignant in 67.5% (326/483), benign in 16.8% (81/483) and non-diagnostic in 15.7% (76/483), leading to a total of 32.5% of ablation of benign or non-diagnostic lesions. Of the patients with a benign biopsy obtained before ablation, 80.4% (37/46) chose not to undergo ablation. Patients with inconclusive biopsy before planned ablation chose an informed individualized approach including ablation, repeated biopsy, or no intervention in 56%, 34% and 10%. CONCLUSION: This study emphasizes the importance of obtaining a biopsy prior to the ablation procedure in a separate session to lower the rate of potentially unnecessary ablations.

Utilization of renal mass biopsy in patients with localized renal cell carcinoma: A population-based study utilizing the National Cancer Database.

OBJECTIVE: To evaluate trends and factors predicting use of renal mass biopsy (RMB) for localized Renal Cell Carcinoma in the United States (US) in the context of current guidelines recommendations. METHODS: We queried the National Cancer Database for cT1-cT3N0M0 Renal Cell Carcinoma diagnosed between 2004 and 2015. Temporal trends of RMB were characterized based on tumor size, treatment (partial nephrectomy [PN], radical nephrectomy [RN], ablation, and no treatment), age and Charlson Comorbidity Index with slopes compared using analysis of variance. Multivariable analysis was used to determine factors associated with use of RMB. RESULTS: Of 338,252 patients analyzed, 11.9% (40,276) underwent RMB. Use of RMB increased throughout the study period from 1,586 (7.6%) in 2004 to 5,629 (16.2%) in 2015 (P < 0.001). Use of RMB increased greatest for ablation (27 to 63%, P < 0.001) and tumors 2-4 cm (9 to 20%, P < 0.001). Multivariable analysis showed year of diagnosis (OR = 1.06; P < 0.001), higher education (OR = 1.09; P < 0.001) and insured status (OR = 1.23; P < 0.001) were associated with increased RMB. Compared to tumors ≤2 cm, tumors 2.1-4 cm (OR = 1.36; P=<0.001), 4.1-7 cm (OR = 1.18; P <0.001) and >7 cm (OR = 1.05; P = 0.03) were associated with higher rates of RMB. Compared to RN, PN was not associated with increased RMB (OR = 1.00; P = 0.92), while ablation (OR = 10.90; P < 0.001) and no surgical treatment (OR = 4.83; P < 0.001) were. CONCLUSION: RMB utilization increased overall, with largest increase associated with ablation. Nonetheless, only two-thirds of patients underwent RMB with ablation, suggesting persistent underutilization. Rates of RMB for tumors ≤2 cm and in those undergoing no treatment increased less, suggesting less utilization for surveillance. However, rates for tumors >2-4 cm increased more, suggesting selective utilization of RMB to guide decision-making and risk stratification in small renal masses.

Contemporary Results and Clinical Utility of Renal Mass Biopsies in the Setting of Ablative Therapy: A single center experience.

PURPOSE: Clinical guidelines have recently included renal mass biopsy (RMB) in management algorithms, especially in the setting of small renal masses ≤ 4 cm (SRM) and ablative therapy. We sought to evaluate the diagnostic rates of RMB, factors associated with a non-diagnostic biopsy, its clinical utility, and its safety profile in the setting of ablative therapy. MATERIALS AND METHODS: A total of 174 RMB from 167 patients, performed in a tertiary academic center from 01/2015 to 01/2019, were included. Patient demographics, radiographic mass size, RMB diagnoses, subsequent clinical management, and complications were retrospectively reviewed. RMBs were classified as diagnostic or non-diagnostic based on set criteria. RESULTS: The mean mass size was 3.0 cm (range: 0.5-15.3 cm) and 140 biopsies (80%) were SRM. Among all RMB, 159 (91%) were diagnostic and 15 (9%) were non-diagnostic. Non-diagnostic biopsies were associated with small mass size, the presence of a cystic component (p < 0.00001) and fewer number of cores submitted (p = 0.0046). All non-diagnostic biopsies occurred in SRMs, where the mean mass size was significantly smaller than diagnostic biopsies (1.3 versus 3.2 cm, p = 0.001). RMB with concurrent ablation yielded non-diagnostic results more frequently than isolated RMBs (15% vs 2%, respectively). CONCLUSIONS: RMB is useful for definitive diagnosis and clinical management in the setting of ablative therapy. Small mass size, cystic lesions, and fewer number of passes obtained are associated with non-diagnostic biopsies. When a renal mass diagnosis is particularly critical, a separate biopsy procedure prior to ablative therapy is recommended.

Contemporary trends in percutaneous renal mass biopsy utilization in the United States.

INTRODUCTION: Patients with a renal mass traditionally proceed directly to surgery without a preoperative tissue diagnosis confirming malignancy. Many surgically treated renal masses represent benign tumors or indolent malignancies on final pathology. This has led to a growing body of literature supporting an expanded role for percutaneous renal mass biopsy (RMB). This study aims to characterize national trends in RMB utilization. METHODS: Patients undergoing renal biopsy during a 12-year period (2006-2017) in the Premier Hospital Database were captured using International Classification of Diseases, Ninth Revision and Tenth Revision codes. We restricted our analysis to patients with a concurrent diagnosis of a renal mass. We determined utilization rate, subsequent interventions within 90 days of biopsy, predictors of RMB, and 30-day RMB complication rates. We applied sampling weights and adjusted for hospital clustering to achieve a nationally representative analysis. RESULTS: Among 115,511 patients who met the inclusion criteria, the annual number of RMB rose from 7,196 in 2006 to 11,528 in 2017; during this period, more than 3 times as many patients proceeded directly to surgery without a prior RMB. After RMB, 85,848 (74.32%) patients were not treated within 90 days. Of those treated, thermal ablation was more common than surgery (17,269 vs. 12,394). Trend analysis showed that patients with metastatic disease represented a decreasing proportion of patients receiving RMB (27.0%-21.8%; P < 0.001). Compared to patients who proceeded directly to surgery, RMB was more commonly performed in patients in the highest age group (80 years and older, 15.9% vs. 9.2%), unmarried (50% vs. 45.9%), with more medical comorbidities (Charlson comorbidity index ≥4, 30.9% vs. 17.4%), or with metastatic disease (24.5% vs. 10.4%). Multivariable regression analysis determined the primary predictor of RMB was the presence of metastatic disease. Hematuria was the most common complication present in 5.18% of patients followed by pneumothorax in 1.75%. All other complications were rare (<0.4%). CONCLUSION: Although there has been progressive adoption of RMB for the management of renal masses in the United States, utilization remains relatively limited and differentially employed across the population based on both clinical and nonclinical patient factors. More research is needed to understand which factors are considered when determining whether to utilize RMB in the evaluation of a renal mass.

Biopsy Cell Cycle Proliferation Score Predicts Adverse Surgical Pathology in Localized Renal Cell Carcinoma.

Active surveillance (AS) is an accepted management strategy for some patients with renal cell carcinoma, but limited tools are available to identify optimal AS candidates. While renal mass biopsy provides diagnostic information, risk stratification based on biopsy is limited. In a retrospective, multi-institutional cohort that underwent renal mass biopsy followed by surgery, we assessed the ability of the cell cycle proliferation (CCP) score from clinical biopsy specimens to predict adverse surgical pathology (ie, grade 3-4, pT stage ≥3, metastasis at surgery, or papillary type II). Of 202 patients, 98 (49%) had adverse surgical pathology. When added to a baseline model including age, sex, race, lesion size, biopsy grade, and histology, CCP score was significantly associated with adverse pathology when modeled as a binary (odds ratio [OR]: 2.44 for CCP score >0, p = 0.02) and a continuous (OR: 1.72 per one unit increase, p = 0.04) variable. Discriminative performance measured by the area under the curve (AUC) improved from 0.73 in the baseline model to 0.75 and 0.76 in models including the CCP score. In the subgroup of patients with nephrectomy CCP score available (n = 67), the biopsy-based model outperformed the nephrectomy-based model (AUC 0.78 vs 0.75). These data support prospective assessment of biopsy CCP score to confirm clinical validity and assess potential utility in AS-eligible patients. PATIENT SUMMARY: In patients with localized renal cell carcinoma who underwent renal mass biopsy followed by surgery, the cell cycle proliferation score from clinical biopsy specimens could predict adverse surgical pathology.