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

• Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy (Other)
• Overall Status: Completed
• CT.gov ID: NCT05659433
• Collaborator: Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor (Other)
• Enrollment: 160
• Location: 1
• Arms: 2
• Actual Duration (Months): 94.9
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retroperitoneal Neoplasms	Procedure: CEUS-guided percutaneous biopsy; Procedure: B-mode US-guided percutaneous biopsy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Contrast-enhanced vs. B-mode Ultrasound-guided Percutaneous Biopsy of Retroperitoneal Tumors - a Randomized Controlled Trial
• Actual Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Sep 15, 2022
• Actual Study Completion Date: Nov 30, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Number of patients with a biopsy sample adequate for pathology interpretation [4 weeks]

Secondary Outcome Measures

1. Number of patients requiring a second biopsy due to prior inadequate sampling [6 weeks]

2. Number of patients with procedural-related adverse events [One week]

   Bleeding, hematoma, puncture-site infection, prolonged hospitalisation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prof. Dr. O. Fodor Regional Institute of Gastroenterology and Hepatology	Cluj-Napoca	Cluj County	Romania	400162

Sponsors and Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rareș Crăciun, Principal Investigator, Iuliu Hatieganu University of Medicine and Pharmacy
• ClinicalTrials.gov Identifier: NCT05659433
• Other Study ID Numbers: CEUS-PBRT
• First Posted: Dec 21, 2022
• Last Update Posted: Dec 21, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Rareș Crăciun, Principal Investigator, Iuliu Hatieganu University of Medicine and Pharmacy: Percutaneous biopsy; Contrast-enhanced ultrasonography; CEUS; Retroperitoneal neoplasms
• Additional relevant MeSH terms: Retroperitoneal Neoplasms

Study Results

No Results Posted as of Dec 21, 2022