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Completed

NCT Number: NCT05659433

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

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.

Completed

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Key information

Conditions

Retroperitoneal Neoplasms Abdominal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prof. Dr. O. Fodor Regional Institute of Gastroenterology and Hepatology

Cluj-Napoca, Cluj, 400162, Romania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

B-mode US-guided percutaneous biopsy

Procedure

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

Primary outcomes

  1. Number of patients with a biopsy sample adequate for pathology interpretation

    Time frame: 4 weeks

Secondary outcomes

  1. Number of patients requiring a second biopsy due to prior inadequate sampling

    Time frame: 6 weeks

  2. Number of patients with procedural-related adverse events

    Time frame: One week

    Bleeding, hematoma, puncture-site infection, prolonged hospitalisation

Sponsors and collaborators

Lead sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Other

Collaborators

  • Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Dec 21, 2022
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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