Office-based Percutaneous Ultrasound-guided Renal Biopsy

N/ACompletedNCT02075684

University of California, Irvine60 enrolled

Overview

The purpose of this research study is to create a prospectively maintained, multicenter database of patients undergoing renal biopsy for renal masses performed percutaneously (through skin), via an 18 gauge biopsy needle (.048 inches). In this database, the investigators will collect and maintain the data from the biopsy procedure. This will allow us to evaluate our experience with this procedure as well as to participate in multi-institutional collaborative studies in the future. At University of California Irvine, the investigators routinely biopsy patients with renal masses under real-time ultrasound control. Percutaneous renal biopsy under ultrasound guidance is a routine procedure performed to diagnose renal mass histopathology. The safety and efficacy of this procedure has been well documented in the literature. The indications for percutaneous renal biopsy have expanded as there has been a substantial increase in the number of renal masses that are being diagnosed, and the acceptance of percutaneous biopsy continues to expand in parallel. The biopsy procedure is part of your normal standard of care and if not being done for this research project.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Renal Cortical Neoplasms

Interventions

Renal BiopsyPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Must be undergoing standard percutaneous renal biopsy * Patients must be ≥18 years of age * Must be able to understand and render voluntary, written informed consent Exclusion Criteria: * Patients \<18 years of age * Pregnant women * Coagulopathy * Active urinary tract infection

Locations (1)

Universty of California Irvine Medical Center

Orange, California, United States

Outcomes

Primary Outcomes

Tumor Characteristics

Tumor characteristics will be recorded at Baseline (from preoperative imaging) using the R.E.N.A.L. Nephrometry scoring system which captures tumor radius (R), depth within renal parenchyma (E), nearness to collecting system (N), anterior/posterior location (A) and polarity (L).

Time frame: Baseline

Secondary Outcomes

Verbal analog pain scale

Preprocedural and postprocedure verbal analog pain scale. Verbal analog pain scale (0 to 10) will be recorded immediately after and 60 minutes after the procedure. Additional pain assessment will be performed at a follow-up visit 3 days to 3 weeks after the procedure.

Time frame: Baseline, 1 hour post procedure, and 3 days - 3 weeks post-procedure

Data from ClinicalTrials.gov

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