Contrast-enhanced vs. B-mode Ultrasound-guided Percutaneous Biopsy of Retroperitoneal Tumors

Study Overview
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Brief Summary
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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.

Official Title
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Contrast-enhanced vs. B-mode Ultrasound-guided Percutaneous Biopsy of Retroperitoneal Tumors - a Randomized Controlled Trial

Conditions
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Retroperitoneal Neoplasms

Intervention / Treatment
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* Procedure: CEUS-guided percutaneous biopsy
* Procedure: B-mode US-guided percutaneous biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: B-mode Ultrasound-guided Biopsy<br> | Procedure: B-mode US-guided percutaneous biopsy<br>* Standard of care (B-mode) ultrasound-guided percutaneous biopsy, without contrast enhancement<br>|
| Experimental: Contrast-enhanced Ultrasound-guided Biopsy<br> | Procedure: CEUS-guided percutaneous biopsy<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with a biopsy sample adequate for pathology interpretation |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | One week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous biopsy, Contrast-enhanced ultrasonography, CEUS, Retroperitoneal neoplasms