Office-based Percutaneous Ultrasound-guided Renal Biopsy

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 Overview

• Status: Completed
• Conditions: Renal Cortical Neoplasms
• Intervention / Treatment: Procedure: Renal Biopsy

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Universty of California Irvine Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: In-office, Percutaneous Renal Biopsy	Procedure: Renal Biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 1 hour post procedure, and 3 days - 3 weeks post-procedure

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: University of California, Los Angeles; University of Michigan; Vanderbilt University
• Investigators: Principal Investigator: Jaime Landman, MD, UCI Health Department of Urology

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: August 21, 2013
• First Submitted That Met QC Criteria: February 28, 2014
• First Posted (Estimated): March 3, 2014

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 20139312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not intend to release individual data to other researchers.

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No