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

I

Iuliu Hatieganu University of Medicine and Pharmacy

Status

Completed

Conditions

Retroperitoneal Neoplasms

Treatments

Procedure: B-mode US-guided percutaneous biopsy
Procedure: CEUS-guided percutaneous biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT05659433
CEUS-PBRT

Details and patient eligibility

About

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.

Enrollment

160 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

160 participants in 2 patient groups

B-mode Ultrasound-guided Biopsy
Active Comparator group
Treatment:
Procedure: B-mode US-guided percutaneous biopsy
Contrast-enhanced Ultrasound-guided Biopsy
Experimental group
Treatment:
Procedure: CEUS-guided percutaneous biopsy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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