Office-based Percutaneous Ultrasound-guided Renal Biopsy

NCT02075684 | Completed DMC

• 1 other identifier: 20139312
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cortical Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Verbal analog pain scale

  Baseline, 1 hour post procedure, and 3 days - 3 weeks post-procedure

Study Arms (1)

In-office, Percutaneous Renal Biopsy

OTHER

Procedure: Renal Biopsy

Interventions

Renal Biopsy PROCEDURE

In-office, Percutaneous Renal Biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients \<18 years of age
• Pregnant women
• Coagulopathy
• Active urinary tract infection

Sponsors & Collaborators

• University of California, Irvine: lead
• University of Michigan: collaborator
• University of California, Los Angeles: collaborator
• Vanderbilt University: collaborator

Study Sites (1)

Universty of California Irvine Medical Center

Orange, California, 92868, United States

Location

Related Links

• Related Info

Study Officials

• Jaime Landman, MD

  UCI Health Department of Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology and Radiology

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: March 3, 2014
• Study Start: April 1, 2013
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)