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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05659433

Enrollment

160

Registered

2022-12-21

Start date

2015-01-01

Completion date

2022-11-30

Last updated

2022-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retroperitoneal Neoplasms

Keywords

Percutaneous biopsy, Contrast-enhanced ultrasonography, CEUS, Retroperitoneal neoplasms

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.

Interventions

PROCEDURECEUS-guided percutaneous biopsy

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)

PROCEDUREB-mode US-guided percutaneous biopsy

Standard of care (B-mode) ultrasound-guided percutaneous biopsy, without contrast enhancement

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of patients with a biopsy sample adequate for pathology interpretation	4 weeks

Secondary

Measure	Time frame	Description
Number of patients requiring a second biopsy due to prior inadequate sampling	6 weeks	—
Number of patients with procedural-related adverse events	One week	Bleeding, hematoma, puncture-site infection, prolonged hospitalisation

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026