Building a Roadmap for Surveillance of Renal Masses Using a Modified Delphi Method to Help Achieve Consensus.

OBJECTIVE: To establish a consensus for initial evaluation and follow-up of patients on active surveillance (AS) for T1 renal masses (T1RM). METHODS: A modified Delphi method was used to gather information about AS of T1RM, with a focus on patient selection, timing/type of imaging modality, and triggers for intervention. A consensus panel of Michigan Urological Surgery Improvement Collaborative-affiliated urologists who routinely manage renal masses was formed. Areas of consensus (defined >80% agreement) about T1RM AS were established iteratively via 3 rounds of online questionnaires. RESULTS: Twenty-six Michigan Urological Surgery Improvement Collaborative urologists formed the panel. Consensus was achieved for 321/587 scenarios (54.7%) administered through 124 questions. Life expectancy, age, comorbidity, and renal function were most important for patient selection, with life expectancy ranking first. All tumors <3 cm and all patients with life expectancy <1 year were considered appropriate for AS. Appropriateness also increased with elevated perioperative risk, increasing tumor complexity, and/or declining renal function. Consensus was for multiphasic axial imaging initially (contrast CT for GFR >60 or MRI for GFR >30) with first repeat imaging at 3-6 months and subsequent imaging timing determined by tumor size. Consensus was for chest imaging for tumors >3 cm initially and >5 cm at follow up. Renal biopsy was not felt to be a requirement for entering AS, but useful in several scenarios. Consensus indicated rapid tumor growth as an appropriate trigger for intervention. CONCLUSION: Our consensus panel was able to achieve areas of consensus to help define a clinically useful and specific roadmap for AS of T1RM and areas for further discussion where consensus was not achieved.

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.

Development of a Novel Scoring System Quantifies Opportunities to Reduce Surgery for Benign Renal Neoplasms: A Retrospective Quality Improvement Analysis within the MUSIC-KIDNEY Collaborative.

PURPOSE: Nonmalignant pathology has been reported in 15% to 20% of surgeries for cT1 renal masses. We seek to identify opportunities for improvement in avoiding surgery for nonmalignant pathology. MATERIALS AND METHODS: MUSIC-KIDNEY started collecting data in 2017. All patients with cT1 renal masses who had partial or radical nephrectomy for nonmalignant pathology were identified. Category for improvement (none-0, minor-1, moderate-2 or major-3) was independently assigned to each case by 5 experienced kidney surgeons. Specific strategies to decrease nonmalignant pathology were identified. RESULTS: Of 1,392 patients with cT1 renal masses 653 underwent surgery and 74 had nonmalignant pathology (11%). Of these, 23 (31%) cases were cT1b. Radical nephrectomy was performed in 17 (22.9%) patients for 5 cT1a and 12 cT1b lesions. Only 6 patients had a biopsy prior to surgery (5 oncocytoma, 1 unclassified renal cell carcinoma). Review identified 25 cases with minor (34%), 26 with moderate (35%) and 10 with major (14%) quality improvement opportunities. Overall 17% of cases had no quality improvement opportunities identified (12 partial nephrectomy, 1 radical nephrectomy). CONCLUSIONS: Review of patients with cT1 renal masses who underwent surgery for nonmalignant pathology revealed a significant number of cases in which this outcome may have been avoided. Approximately half of cases had moderate or major quality improvement opportunities, with radical nephrectomy for nonmalignant pathology being the most common reason. Our data indicate a lowest achievable and acceptable rate of nonmalignant pathology to be 1.9% and 5.4%, respectively. Avoiding interventions for nonmalignant pathology, particularly radical nephrectomy, is an important focus of quality improvement efforts. Strategies to decrease unnecessary interventions for nonmalignant pathology include greater use of repeat imaging, renal mass biopsy and surveillance.

Surgical Management of a Giant Pheochromocytoma.

Pheochromocytomas are rare tumors arising from chromaffin cells of the adrenal medulla and extramedullary sympathetic ganglia. The incidence of asymptomatic disease is rising due to increased detection rates from widespread use of computed tomography. We describe a case of one of the largest documented pheochromocytomas resected in the United States, an 18-cm tumor in a patient who presented with exertional dyspnea, abdominal pain, constipation, weight loss, and intermittent hypertension. After biochemical and appropriate imaging workup, the patient underwent an open resection of the mass.

A Retrospective Comparative Outcomes and Cost Analysis of Office Based, Ultrasound Guided Renal Mass Biopsy Performed by Urologists and Standard Hospital Biopsies for Small Renal Masses.

INTRODUCTION: Renal mass biopsy is useful in the evaluation of small renal masses. We have previously reported that office based, ultrasound guided renal mass biopsy is safe, effective and feasible when performed by urologists. This study compares office based, ultrasound guided renal mass biopsy performed by urologists and hospital based renal mass biopsy. METHODS: We retrospectively studied 70 patients who underwent office based, ultrasound guided renal mass biopsy and 155 who underwent hospital based, ultrasound or computerized tomography guided renal mass biopsy for evaluation of a small renal mass (4.0 cm or less) between January 2010 and February 2016. RESULTS: A total of 70 patients underwent office based, ultrasound guided renal mass biopsy. Median age in this group was 69.5 years, median body mass index was 29.5 kg/m2 and 61.4% of the patients (43) were male. A total of 103 patients underwent hospital based, ultrasound guided biopsy. Median age in this group was 68.0 years, median body mass index was 29.3 kg/m2 and 53.4% of the patients (55) were male. Finally, 52 patients underwent hospital based, computerized tomography guided biopsy. Median age in this group was 69 years, median body mass index was 30.1 kg/m2 and 51.9% of the patients (27) were male. Median tumor size was 2.7 cm in patients undergoing office based, ultrasound guided renal mass biopsy, 2.2 cm in those undergoing hospital based, ultrasound guided biopsy and 2.1 cm in those undergoing hospital based, computerized tomography guided biopsy (p = 0.001). Renal cell carcinoma was found in 43 of 70 (61.4%), 74 of 103 (71.8%) and 33 of 52 (63.5%) respective biopsies. Respective diagnostic rates were 81.4% (57 of 70 cases), 88.3% (91 of 103) and 86.5% (45 of 52, p = 0.434). Concordance with surgical pathology was 97.7% (42 of 43 cases), 100% (35 of 35) and 100% (15 of 15), respectively. Complication rates were 4.3% (3 of 70 patients), 13.6% (14 of 103) and 13.5% (7 of 52), respectively (p = 0.096). Cost analysis revealed that when available, office based, ultrasound guided renal mass biopsy provides the health care system a total savings of approximately $46,011 yearly. CONCLUSIONS: Office based, ultrasound guided renal mass biopsy for small renal masses is a safe and efficacious option for select patients, and potentially offers greater convenience and availability as well as decreased health care costs.

Use of Routine Home Health Care and Deviations From an Uncomplicated Recovery Pathway After Radical Prostatectomy.

OBJECTIVE: To evaluate the statistical association between routine home health use after prostatectomy, short-term surgical outcomes, and payments. METHODS: We identified all men who underwent a robotic radical prostatectomy from April 1, 2014, to October 31, 2015, in the Michigan Urological Surgery Improvement Collaborative (MUSIC) with insurance from Medicare or a large commercial payer. We calculated rates of "routine" home care use after prostatectomy by urology practice. We defined "routine" home care as home care initiated within 4 days of discharge among patients discharged without a pelvic drain. We then compared emergency department (ED) visits, readmissions, prolonged catheter use, catheter reinsertion rates, and 90-day episode payments, in unadjusted and using a propensity-adjusted analysis, for those who did and did not receive home care. RESULTS: We identified 647 patients, of whom 13% received routine home health care. At the practice level, the use of routine home care after prostatectomy varied from 0% to 53% (P = .05) (mean: 3.6%, median: 0%). Unadjusted, patients with routine home care had increased ED visits within 16 days (15.5% vs 6.9%, P <.01), similar rates of catheter duration for >16 days (3.6% vs 3.0%, P = .79) and need for catheter replacement (1.2% vs 2.5%, P = .46), and a trend toward decreased readmissions (0% vs 4.1%, P = .06). Only the increased ED visits remained significant in adjusted analyses (P <.01). Home health had an average payment of $1000 per episode. CONCLUSION: Thirteen percent of patients received routine home health care after prostatectomy, without improved outcomes. These findings suggest that patients do not routinely require home health care to improve short-term outcomes following radical prostatectomy, however, the appropriate use of home health care should be evaluated further.

Office-based Ultrasound-guided Renal Core Biopsy Is Safe and Efficacious in the Management of Small Renal Masses.

OBJECTIVE: To evaluate the safety and efficacy of ultrasound (US)-guided percutaneous renal mass biopsy (RMB) performed in the office setting by urologists. MATERIALS AND METHODS: This is a retrospective study involving patients who underwent office-based US-guided percutaneous RMB between April 2010 and October 2015. Baseline vital signs and US were performed prior to the procedure. Patients were then observed for 1 hour after the procedure and repeat vital signs and US were performed. Hemodynamically stable patients who did not develop hematoma were discharged. RESULTS: In 108 patients, 70 (64.8%) were male, median age was 69.5 years, and median mass size was 3.3 cm (interquartile range: 2.5-4.6). Biopsy yield was as follows: 72 (66.7%) had renal cell carcinoma, 14 (13.0%) had benign renal parenchyma, 11 (10.2%) had oncocytoma, 6 (5.6%) had angiomyolipoma, 2 (1.9%) had lymphoma, and 3 (2.8%) had other disease. The initial nondiagnostic rate was 14 of 108 (13.0%). There were 28 of 108 (25.9%) patients observed whereas 79 of 108 (73.2%) received surgery or ablative therapy. Final pathology was concordant with biopsy results in 66 of 68 (97.1%) cases. Three patients experienced a grade I Clavien-Dindo surgical complication, all of which were managed conservatively. CONCLUSION: Office-based US-guided RMB is safe and efficacious in the management of appropriately selected SRM. It potentially offers improved dynamic characterization of solid renal mass, greater convenience to patients, as well as cost savings. Further studies are needed to evaluate this promising technique.

Notable Outcomes and Trackable Events after Surgery: Evaluating an Uncomplicated Recovery after Radical Prostatectomy.

PURPOSE: A priority of MUSIC (Michigan Urological Surgery Improvement Collaborative) is to improve patient outcomes after radical prostatectomy. As part of these efforts we developed a novel system that uses unambiguous events to define an uncomplicated 30-day postoperative recovery and compares these outcomes across diverse urology practices. MATERIALS AND METHODS: MUSIC used a consensus approach to develop an uncomplicated recovery pathway comprising a set of precise perioperative events that are reliably measured and collectively reflect resource utilization, technical complications and coordination of care. Events that occurred outside the uncomplicated recovery pathway were considered deviations, including rectal injury, high blood loss, extended length of stay, prolonged drain or catheter placement, catheter replacement, hospital readmission or mortality. For men undergoing radical prostatectomy trained abstractors prospectively recorded clinical and perioperative data in an electronic registry. When a deviation from the NOTES (Notable Outcomes and Trackable Events after Surgery) pathway occurred, precipitating events were described by abstractors and we analyzed the events. RESULTS: From April 2014 through July 2015 a total of 2,245 radical prostatectomies were performed by 100 surgeons in a total of 37 diverse participating MUSIC practices. In the 29 practices in which 10 or more radical prostatectomies were performed during the interval analyzed the risk adjusted deviation rate ranged from 0.0% to 46.1% (p <0.0001). Anastomotic and gastrointestinal events were contributing factors in 50.2% of deviated cases. CONCLUSIONS: The novel NOTES system provides comparative data on unambiguous and actionable short-term outcomes after radical prostatectomy. The observed variation in outcomes across practices suggests opportunities for quality improvement initiatives. Decreasing anastomotic and gastrointestinal events represents a high impact opportunity for initial quality improvement efforts.

One-year monitoring of an oligonucleotide fluorescence in situ hybridization probe panel laboratory-developed test for bladder cancer detection.

BACKGROUND: Previously, we had developed and manufactured an oligonucleotide fluorescence in situ hybridization (OligoFISH) probe panel based on the most clinically sensitive chromosomes found in a reference set of bladder carcinoma cases. The panel was clinically validated for use as a diagnostic and monitoring assay for bladder cancer, reaching 100% correlation with the results of the UroVysion test. After 1 year of using this probe panel, we present here the comparison of cytology, cystoscopy, and pathology findings to the OligoFISH probe panel results to calculate its clinical performance. MATERIALS AND METHODS: In order to calculate clinical performance, we compared the OligoFISH results to the cytology and cystoscopy/pathology findings for 147 initial diagnoses and 399 recurrence monitorings. Finally, we compared clinical performance to published values for the UroVysion test, including both low- and high-grade tumors. RESULTS: Chromosomes 3, 6, 7, and 20 were highly involved in bladder carcinoma aneuploidy. At the initial diagnosis, we obtained 90.5% (95% confidence interval [CI]: 84.5%-94.7%) accuracy, 96.8% sensitivity (95% CI: 91.0%-99.3%), 79.2% specificity (95% CI: 65.9%-87.8%), 89.2% positive predictive value (PPV; 95% CI: 81.5%-94.5%), and 93.3% negative predictive value (NPV; 95% CI: 81.7%-97.3%). When monitoring for recurrence, we obtained 85.2% accuracy (95% CI: 81.3%-88.5%), 82.0% sensitivity (95% CI: 76.0%-87.1%), 88.4% specificity (95% CI: 83.2%-92.5%), 87.7% PPV (95% CI: 82.1%-92.0%), and 83.0% NPV (95% CI: 77.3%-87.8%). When looking at low- and high-grade tumors, the test showed 100% sensitivity for high-grade tumors (95% CI: 92.5%-100%) and 87.5% sensitivity (95% CI: 68.8%-95.5%) for low-grade tumors. All the clinical parameters for the OligoFISH panel were higher than the UroVysion test's published performance. We found significantly higher clinical sensitivity and NPV at initial diagnosis and significantly higher specificity and PPV for recurrence. CONCLUSION: The OligoFISH probe panel is a fast, easy, and reproducible test for bladder cancer diagnosis and monitoring, with excellent clinical performance and utility.

The effect of pneumoperitoneum on kidney function in laparoscopic donor nephrectomy.

Between June 1999 and November 2001 a prospective study was conducted to evaluate the effects of pneumoperitoneum during laparoscopic donor nephrectomy on kidney function using two different pressure settings (15 and 10 mm Hg). The effects were evaluated in both the donor's remaining kidney and the procured kidney in the recipient. There was no statistical significant difference in donors and recipients in regard to age, gender, and body mass index. In the two donor groups there was no difference in operative time (2.77 +/- 0.51 vs 2.70 +/- 0.52 hours; P = 0.579), intraoperative fluid (16.53 +/- 4.72 vs 19.54 +/- 7.04, P = 0.056), and urine output (1.81 +/- 0.53 vs 1.75 +/- 0.96 mL/kg/hour, P = 0.782) respectively. Donors' preoperative and first-day postoperative serum creatinine concentrations also did not differ for the groups (preoperative 0.87 +/- 0.21 vs 0.88 +/- 0.17 mg/dL; and postoperative 1.44 +/- 0.32 vs 1.38 +/- 0.29 mg dL, respectively; P = 0.696). Recipients' preoperative and postoperative serum creatinine concentrations on days 1, 2, 3, 7, 14, and 30 differed over time (P < 0.001) but not between groups (P = 0.541). We conclude that procurement of kidneys under either 10 or 15 mm Hg abdominal pressure gives equally good intraoperative and postoperative results.