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Clinical Trials/NCT02075684
NCT02075684
Completed
Not Applicable

Office-based Percutaneous Ultrasound-guided Renal Biopsy

University of California, Irvine1 site in 1 country60 target enrollmentApril 1, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Renal Cortical Neoplasms
Sponsor
University of California, Irvine
Enrollment
60
Locations
1
Primary Endpoint
Tumor Characteristics
Status
Completed
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2013
End Date
April 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jaime Landman

Professor of Urology and Radiology

University of California, Irvine

Eligibility Criteria

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)

Study Sites (1)

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