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

Status: Withdrawn

Conditions: Kidney Neoplasms

Treatments: Procedure: Additional biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT02841020

19081

Details and patient eligibility

About

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).

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Control SOC

No Intervention group

Description:

Standard of care is followed

Experimental additional biopsy

Experimental group

Description:

Additional biopsy

Treatment:

Procedure: Additional biopsy