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
Sponsored by
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
No
Eligibility Criteria
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
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
No
Learn more about this trial
Contrast-enhanced vs. B-mode Ultrasound-guided Percutaneous Biopsy of Retroperitoneal Tumors
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