Office-based Percutaneous Ultrasound-guided Renal Biopsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Tumor Characteristics
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Tumor Characteristics
Time Frame: Baseline
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).
Secondary Outcomes
- Verbal analog pain scale(Baseline, 1 hour post procedure, and 3 days - 3 weeks post-procedure)
Investigators
Jaime Landman
Professor of Urology and Radiology
University of California, Irvine