Background: Retroperitoneal tumors are typically large and inhomogeneous, with a variable amount of necrosis within the tumor mass which decreases the diagnostic yield of biopsy (false negative or inadequate). Rationale: Real-time contrast enhancement can highlight the viable tumoral tissue and avoid the necrotic area. Aims: To compare contrast-enhanced ultrasound (CEUS) guidance and conventional (B-mode) ultrasound (US) guidance in terms of diagnostic yield, need for repeat biopsy, and rate of adverse events. Methods: A consecutive series of patients with previously documented retroperitoneal tumors and indications for percutaneous biopsy were randomly assigned to benefit from the standard of practice B-mode US-guided biopsy or CEUS-guided biopsy. The diagnostic accuracy, need for repeat biopsy, and adverse events were noted.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
160
A standard dose of SonoVue ultrasound contrast agent is injected prior to the biopsy, and the percutaneous biopsy is guided in real time, targeting the contrast-enhanced areas of the retroperitoneal tumors (viable, vascularized)
Standard of care (B-mode) ultrasound-guided percutaneous biopsy, without contrast enhancement
Prof. Dr. O. Fodor Regional Institute of Gastroenterology and Hepatology
Cluj-Napoca, Cluj, Romania
Number of patients with a biopsy sample adequate for pathology interpretation
Time frame: 4 weeks
Number of patients requiring a second biopsy due to prior inadequate sampling
Time frame: 6 weeks
Number of patients with procedural-related adverse events
Bleeding, hematoma, puncture-site infection, prolonged hospitalisation
Time frame: One week
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