Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Office-based Percutaneous Ultrasound-guided Renal Biopsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02075684
Recruitment Status : Enrolling by invitation
First Posted : March 3, 2014
Last Update Posted : April 5, 2021
Sponsor:
Collaborators:
University of Michigan
University of California, Los Angeles
Vanderbilt University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Renal Cortical Neoplasms Procedure: Renal Biopsy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 1, 2013
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
In-office, Percutaneous Renal Biopsy Procedure: Renal Biopsy



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Verbal analog pain scale [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02075684


Locations
Layout table for location information
United States, California
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
Layout table for investigator information
Principal Investigator: Jaime Landman, MD UCI Health Department of Urology
Additional Information:
Layout table for additonal information
Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT02075684    
Other Study ID Numbers: 2013-9312
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not intend to release individual data to other researchers.