Back to results

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

Primary Purpose

Retroperitoneal Neoplasms

Status

Completed

Phase

Not Applicable

Locations

Romania

Study Type

Interventional

Intervention

CEUS-guided percutaneous biopsy

B-mode US-guided percutaneous biopsy

About this trial

This is an interventional diagnostic trial for Retroperitoneal Neoplasms focused on measuring Percutaneous biopsy, Contrast-enhanced ultrasonography, CEUS, Retroperitoneal neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

B-mode Ultrasound-guided Biopsy

Contrast-enhanced Ultrasound-guided Biopsy

Arm Description

Outcomes

Primary Outcome Measures

Number of patients with a biopsy sample adequate for pathology interpretation

Secondary Outcome Measures

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

Number of patients with procedural-related adverse events

Bleeding, hematoma, puncture-site infection, prolonged hospitalisation

Full Information

NCT ID

NCT05659433

First Posted

December 3, 2022

Last Updated

December 12, 2022

Sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05659433

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

January 1, 2015 (Actual)

Primary Completion Date

September 15, 2022 (Actual)

Study Completion Date

November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retroperitoneal Neoplasms

Keywords

Percutaneous biopsy, Contrast-enhanced ultrasonography, CEUS, Retroperitoneal neoplasms

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

B-mode Ultrasound-guided Biopsy

Arm Type

Active Comparator

Arm Title

Contrast-enhanced Ultrasound-guided Biopsy

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

CEUS-guided percutaneous biopsy

Intervention Description

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)

Intervention Type

Procedure

Intervention Name(s)

B-mode US-guided percutaneous biopsy

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of patients with a biopsy sample adequate for pathology interpretation

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

6 weeks

Title

Number of patients with procedural-related adverse events

Description

Bleeding, hematoma, puncture-site infection, prolonged hospitalisation

Time Frame

One week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zeno Spârchez, MD, Prof.

Organizational Affiliation

Prof. Dr. O. Fodor Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

Cluj-Napoca

State/Province

Cluj County

ZIP/Postal Code

400162

Country

Romania

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs