Contrast-enhanced vs. B-mode Ultrasound-guided Percutaneous Biopsy of Retroperitoneal Tumors - a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- Number of patients with a biopsy sample adequate for pathology interpretation
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients with retroperitoneal tumors with indication for percutaneous biopsy
Exclusion Criteria
- •Tumors inaccessible for ultrasound guided biopsy
- •Standard contraindications for biopsy (altered coagulation tests, poor performance status)
- •Lack of written informed consent
Outcomes
Primary Outcomes
Number of patients with a biopsy sample adequate for pathology interpretation
Time Frame: 4 weeks
Secondary Outcomes
- Number of patients with procedural-related adverse events(One week)
- Number of patients requiring a second biopsy due to prior inadequate sampling(6 weeks)
Investigators
Rareș Crăciun
Principal Investigator
Iuliu Hatieganu University of Medicine and Pharmacy