Contrast-enhanced Ultrasound Versus CT Scan for Kidney Stone Patient Management

Summary

This study will be a randomized controlled study comparing the use of two clinical management strategies in nephrostomy tube management following percutaneous nephrolithotomy (PCNL). The first strategy entails using contrast-enhanced ultrasound (CEUS) to evaluate the renal collecting system (1). This is a new imaging approach applying ultrasound machines with special software in combination with intraluminal ultrasound contrast agent (Lumason) injection, which is an FDA-approved ultrasound contrast agent (2). The second strategy is a nephrostomy tube capping trial combined with low dose non-contrast computed tomography (CT) scan, one of the most frequently utilized clinical management strategies currently used in clinical practice (3).

Conditions

• Ultrasonography
• Nephrolithiasis

Interventions

DRUG

CEUS

In subjects randomized into the CEUS arm, 2 mL of Lumason will be injected as a single dose via a nephrostomy tube at the time of postoperative renal ultrasound, following by 5 mL of normal saline flush. Subjects will be given up to one additional dose injected in the same fashion as indicated during the imaging study to confirm opacification of the ureter.

DIAGNOSTIC_TEST

Non-contrast CT scan

The CT scan performed in this study arm is regularly performed to evaluate the kidney and look for residual stones after surgery both at UCSF and around the world. It does not require contrast injection, so risks from contrast allergy or any injection are absent. A low dose protocol will be used, and therefore, subjects will be exposed to a very small amount of ionizing radiation as low as 1-2 mSv if randomized into this arm.

DIAGNOSTIC_TEST

Capping trial

Subjects who are randomized into this study arm will undergo both nephrostomy tube capping and a low dose non-contrast CT scan on the first day after surgery. Successfully passing a capping trial is defined as the absence of fever, worsened flank pain, and leakage around the nephrostomy tube within 4 hours after capping the tube.

Sponsors & Collaborators

• Oregon Health and Science University

  collaborator OTHER

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Thomas Chi, MD · UCSF Department of Urology

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-30

Primary Completion

2022-05-02

Completion

2022-05-02

FDA Drug

Yes