Office-based Percutaneous Ultrasound-guided Renal Biopsy

Not Applicable

Completed

• Conditions: Renal Cortical Neoplasms
• Interventions: Procedure: Renal Biopsy

• Registration Number: NCT02075684
• Lead Sponsor: University of California, Irvine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-01
• Study First Submitted: 2013-08-21
• Study First Submitted QC: 2014-02-28
• Study First Posted: 2014-03-03
• Primary Completion: 2024-04
• Study Completion: 2024-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
In-office, Percutaneous Renal Biopsy	Renal Biopsy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Universty of California Irvine Medical Center; 🇺🇸 Orange, California, United States