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| Name | Class |
|---|---|
| Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B-mode Ultrasound-guided Biopsy | Active Comparator |
| |
| Contrast-enhanced Ultrasound-guided Biopsy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CEUS-guided percutaneous biopsy | Procedure | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with a biopsy sample adequate for pathology interpretation | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients requiring a second biopsy due to prior inadequate sampling | 6 weeks | |
| Number of patients with procedural-related adverse events | Bleeding, hematoma, puncture-site infection, prolonged hospitalisation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zeno Spârchez, MD, Prof. | Prof. Dr. O. Fodor Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof. Dr. O. Fodor Regional Institute of Gastroenterology and Hepatology | Cluj-Napoca | Cluj | 400162 | Romania |
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| ID | Term |
|---|---|
| D012186 | Retroperitoneal Neoplasms |
| ID | Term |
|---|---|
| D000008 | Abdominal Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| B-mode US-guided percutaneous biopsy | Procedure | Standard of care (B-mode) ultrasound-guided percutaneous biopsy, without contrast enhancement |
|
| One week |