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

• Status: Not yet recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Oregon Health and Science University

Criteria

Inclusion Criteria:

• Age of 18 years or older.

• Renal and/or ureteral stone of any size diagnosed either by ultrasound or CT scan and requiring surgical treatment with percutaneous removal (PCNL).

Exclusion Criteria:

• A second stage PCNL is planned or expected after surgery, entailing that postoperative tube management is pre-determined.

• Subjects with serious illness likely to cause death within the next 5 years, so as to exclude significant metabolic derangements that might lead to adverse surgical outcome.

• Subjects with a history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason

• Pregnancy, which is a contraindication to both CT scan and ultrasound contrast injection.