Agency for Healthcare Research and Quality.

Purpose-Several options exist for management of clinically localized renal masses suspicious for cancer, including active surveillance, thermal ablation and radical or partial nephrectomy. We summarize evidence on effectiveness and comparative effectiveness of these treatment approaches for patients with a renal mass suspicious for localized renal cell carcinoma. Materials and Methods-We searched MEDLINE®, Embase® and the Cochrane CentralRegister of Controlled Trials from January 1, 1997 through May 1, 2015. Paired investigators independently screened articles to identify controlled studies of management options or cohort studies of active surveillance, abstracted data sequentially and assessed risk of bias independently. Strength of evidence was graded by comparisons.Results-The search identified 107 studies (majority T1, no active surveillance or thermal ablation stratified outcomes of T2 tumors). Cancer specific survival was excellent among all management strategies (median 5-year survival 95%). Local recurrence-free survival was inferior for thermal ablation with 1 treatment but reached equivalence to other modalities after multiple treatments. Overall survival rates were similar among management strategies and varied with age and comorbidity. End-stage renal disease rates were low for all strategies (0.4% to 2.8%). Radical nephrectomy was associated with the largest decrease in estimated glomerular filtration rate and highest incidence of chronic kidney disease. Thermal ablation offered the most favorable perioperative outcomes. Partial nephrectomy showed the highest rates of urological complications but overall rates of minor/major complications were similar among interventions. Strength of evidence was moderate, low and insufficient for 11, 22 and 30 domains, respectively. * Correspondence: 600 N. Wolfe St., Park Building, Room 223, Baltimore, Maryland 21287 (telephone: 618-534-4942; FAX: 410-502-7711; hitenpatel@jhmi.edu). No direct or indirect commercial incentive associated with publishing this article.The corresponding author certifies that, when applicable, a statement(s) has been included in the manuscript documenting institutional review board, ethics committee or ethical review board study approval; principles of Helsinki Declaration were followed in lieu of formal ethics committee approval; institutional animal care and use committee approval; all human subjects provided written informed consent with guarantees of confidentiality; IRB approved protocol number; animal approved project number.References 51 through 88 can be obtained at http://jurology.com/. HHS Public Access METHODS Data Sources and SearchesWe report results from a broader systematic review. Data Synthesis and AnalysisAll studies were summarized qualitatively. LRFS was defined as the absence of any persistent or recurrent disease in the treated region of the kidney or associated renal fossa after a single, curative intent initial treatment. This definition included persistent enhancement of any treated mass, a visually e...

Purpose-Clinical practice varies widely on the diagnostic role of biopsy for clinically localized renal masses suspicious for renal cell carcinoma. Therefore, we performed a systematic review of the available literature to quantify the accuracy and rate of adverse events of renal mass biopsy. (January 1997 to May 2015 for relevant studies. The systematic review process established by the Agency for Healthcare Research and Quality was followed. Nondiagnostic biopsies were excluded from diagnostic accuracy calculations. Materials and Methods-MEDLINE®, Embase® and the Cochrane databases were searchedResults-A total of 20 studies with 2,979 patients and 3,113 biopsies were included in the study. The overall nondiagnostic rate was 14.1% with 90.4% of those undergoing surgery found to have malignancy. Repeat biopsy led to diagnosis in 80% of patients. The false-positive rate was low (4.0%), histological and renal cell carcinoma subtype concordance was substantial, and Fuhrman upgrading notable (16%) from low grade (1 to 2) to high grade (3 to 4). Core biopsy was highly sensitive (97.5%, CI 96.5-98.5) and specific (96.2%, CI 90.7-100) when a diagnostic result was obtained, but most patients (~80%) did not undergo surgery after a benign biopsy. Among patients undergoing extirpation 36.7% with a negative biopsy had malignant disease on surgical pathology (negative predictive value 63.3%, CI 52.4-74.2). Direct complications included hematoma (4.9%), clinically significant pain (1.2%), gross hematuria (1.0%), pneumothorax (0.6%) and hemorrhage (0.4%).Conclusions-Diagnostic accuracy was generally high for biopsy of localized renal masses with a low complication rate, but the nondiagnostic rate and negative predictive value were concerning. Renal mass sampling should be used judiciously as further research will determine its true clinical utility. *Correspondence: 600 N. Wolfe St., Park Building, Room 223, Baltimore, Maryland 21207 (telephone: 610-534-4942; FAX: 410-502-7711; hitenpatel@jhmi.edu). No direct or indirect commercial incentive associated with publishing this article. Editor's Note:This article is the first of 5 published in this issue for which category 1 CME credits can be earned. Instructions for obtaining credits are given with the questions on pages 1628 and 1629. HHS Public Access MATERIALS AND METHODSThe methods of this systematic review follow the AHRQ Methods Guide for Effectiveness and Comparative Effectiveness Reviews. 9 In an open process representatives of various stakeholder groups developed Key Questions, which are posted on the AHRQ web site for public comments (www.effectivehealthcare.ahrq.gov). The final review protocol was registered on PROSPERO (CRD42015015878, fig. 1). MEDLINE, Embase and the Cochrane Central Register of Controlled Trials were searched from January 1, 1997 through May 1, 2015.The systematic review focused on 3 major topics, of which 1 topic included 2 questions on renal mass sampling for masses suspicious for stage I or II RCC. 1) What is the accuracy (eg sensitivit...

Agency for Healthcare Research and Quality.

Renal functional implications varied across management strategies for localized renal masses, with worse postoperative renal function for patients undergoing radical nephrectomy compared with other strategies and similar outcomes for partial nephrectomy and thermal ablation. Further attention is needed to quantify the changes in renal function associated with active surveillance and nephron-sparing approaches for patients with preexisting CKD.