Diagnostic Accuracy and Risks of Biopsy in the Diagnosis of a Renal Mass Suspicious for Localized Renal Cell Carcinoma: Systematic Review of the Literature

Abstract

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...

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