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

Retroperitoneal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05659433
• Other study ID #: CEUS-PBRT
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: November 30, 2022

Study information

• Verified date: December 2022
• Source: Iuliu Hatieganu University of Medicine and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: November 30, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Retroperitoneal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Romania	Prof. Dr. O. Fodor Regional Institute of Gastroenterology and Hepatology	Cluj-Napoca	Cluj County

Sponsors (2)

Lead Sponsor	Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy	Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with a biopsy sample adequate for pathology interpretation		4 weeks
Secondary	Number of patients requiring a second biopsy due to prior inadequate sampling		6 weeks
Secondary	Number of patients with procedural-related adverse events	Bleeding, hematoma, puncture-site infection, prolonged hospitalisation	One week