Renal Cortical Neoplasms
Conditions
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.
Interventions
PROCEDURERenal Biopsy
Sponsors
University of Michigan
University of California, Los Angeles
Vanderbilt University
University of California, Irvine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Characteristics | 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
| Measure | Time frame | Description |
|---|---|---|
| Verbal analog pain scale | Baseline, 1 hour post procedure, and 3 days - 3 weeks post-procedure | 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. |
Countries
United States
Outcome results
None listed