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Office-based Percutaneous Ultrasound-guided Renal Biopsy

Sponsor
University of California, Irvine (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT02075684
Collaborator
University of Michigan (Other), University of California, Los Angeles (Other), Vanderbilt University (Other)
180
Enrollment
1
Location
1
Arm
108
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Renal Biopsy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Office-based Percutaneous Ultrasound-guided Renal Biopsy
Actual Study Start Date :
Apr 1, 2013
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

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

Procedure: Renal Biopsy

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universty of California Irvine Medical Center Orange California United States 92868

Sponsors and Collaborators

  • University of California, Irvine
  • University of Michigan
  • University of California, Los Angeles
  • Vanderbilt University

Investigators

  • Principal Investigator: Jaime Landman, MD, UCI Health Department of Urology

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT02075684
Other Study ID Numbers:
  • 2013-9312
First Posted:
Mar 3, 2014
Last Update Posted:
Apr 5, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No

Study Results

No Results Posted as of Apr 5, 2021