The Effect of Pre-treatment Biopsy for Non-neoplastic Renal Disease vs no Biopsy on Estimated Glomerular Filtration Rate in Patients With Small Renal Mass: a Single-center, Single-blinded, Randomized, Parallel Group Clinical Trial

University of Virginia

Overview

The purpose of this study is to determine if biopsy for non-neoplastic renal disease for patients with a small renal mass results in greater postoperative renal function than the current standard of care (no additional biopsy).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Conditions

Kidney Neoplasms

Interventions

Additional biopsyPROCEDURE

• Patients in the experimental group receive the additional biopsy for non-neoplastic disease during the same procedure before the biopsy of the renal mass (with potential for direct benefit to the patient by revealing non-neoplastic renal disease).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 or greater * Scheduled for renal biopsy as part of clinical care * Diagnosis of small renal mass (\< 4cm) based on imaging (CT, MRI, Ultrasound, or other) * Patient must provide written, informed consent for study procedures before randomization * Renal mass must be primarily solid (as opposed to cystic) in nature Exclusion Criteria: * Patients less than 18 years of age * Patients who are prisoners * Women who are pregnant-self reported * Patients with Bosniak 3 or 4 cystic renal masses * Patients with history of renal transplantation * Patients with eGFR less than 30-based on review of clinical labs * Patients on dialysis * Patients with bleeding disorders

Outcomes

Primary Outcomes

difference in change in glomerular filtration rate (GFR)

Time frame: 6 months

Data from ClinicalTrials.gov

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