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

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.

Study Overview

• Status: Completed
• Conditions: Retroperitoneal Neoplasms
• Intervention / Treatment: Procedure: B-mode US-guided percutaneous biopsy; Procedure: CEUS-guided percutaneous biopsy

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Cluj County
    • Cluj-Napoca, Cluj County, Romania, 400162
      • Prof. Dr. O. Fodor Regional Institute of Gastroenterology and Hepatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
• Collaborators: Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
• Investigators: Study Chair: Zeno Spârchez, MD, Prof., Prof. Dr. O. Fodor Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: December 3, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: CEUS; Contrast-enhanced ultrasonography; Percutaneous biopsy; Retroperitoneal neoplasms
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Abdominal Neoplasms; Retroperitoneal Neoplasms
• Other Study ID Numbers: CEUS-PBRT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No