Contrast-Enhanced Ultrasound vs Conventional US-guided Percutaneous Needle Biopsy for Pancreatic Diseases: Prospective Multicenter Randomized Controlled Trial
1 other identifier
interventional
196
1 country
1
Brief Summary
According to previous studies, contrast-enhanced ultrasound (CEUS) -guided Core Biopsy(GB) could improve the diagnosis of biopsy in liver and other superficial mass compared to conventional US-GB. The purpose of this randomized trial is to estimate whether CEUS-GB achieve excellent diagnostic value to conventional US-GB in percutaneous biopsy for pancreatic diseases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2023
CompletedFirst Posted
Study publicly available on registry
February 24, 2023
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedFebruary 24, 2023
February 1, 2023
2.8 years
February 15, 2023
February 15, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic accuracy rate
Diagnostic accuracy rate was defined as the proportion of patients who reached successful diagnosis
6 month
Study Arms (2)
CEUS-guided core biopsy group
EXPERIMENTALUS-guided core biopsy group
ACTIVE COMPARATORInterventions
Core biopsy was used to collect samples for pancreatic diseases under contrast-enhanced ultrasound-guided.
Core biopsy was used to collect samples for pancreatic diseases under conventional ultrasound-guided.
Eligibility Criteria
You may qualify if:
- Age ≥18 years, WHO/ECOG scores \<2;
- Radiographic examination reveal focal pancreatic lesions;
- No history of local treatment for pancreatic lesions, systemic chemotherapy, targeting, immunotherapy, etc;
- Normal organ function, including the following criteria:
- Routine blood test: Hb≥80 g/L; PLT≥50×109/L;
- Coagulation function test: PT\<20s.
You may not qualify if:
- The lesions could not be shown by ultrasound and contrast-enhanced ultrasound;
- Allergic to ultrasound contrast agent;
- Cardiovascular and cerebrovascular diseases, liver, kidney and lung failure with significant clinical symptoms;
- History of unexplained bleeding, severe anemia, bleeding tendency or uncorrected coagulopathy;
- Combined with active infection;
- Massive ascites;
- Patients or family members do not agree to enter the study;
- Pregnant or lactating women;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- xiao-yan xielead
Study Sites (1)
Fujian Provincial Hospital
Fuzhou, Fujian, 350000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
February 15, 2023
First Posted
February 24, 2023
Study Start
March 1, 2023
Primary Completion
December 1, 2025
Study Completion
February 1, 2026
Last Updated
February 24, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share