Back to resultsContrast-Enhanced Ultrasound vs Conventional US-guided Percutaneous Needle Biopsy for Pancreatic Diseases: Prospective Multicenter Randomized Controlled Trial
Primary Purpose
Pancreatic Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Contrast-enhanced ultrasound-guided core biopsy
Conventional ultrasound-guided core biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Pancreatic Disease
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; The investigator considers that there are any other factors that may be inappropriate for inclusion or affect the subject's participation in the study.
Sites / Locations
- Fujian Provincial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CEUS-guided core biopsy group
US-guided core biopsy group
Arm Description
Outcomes
Primary Outcome Measures
Diagnostic accuracy rate
Diagnostic accuracy rate was defined as the proportion of patients who reached successful diagnosis
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05743972
Brief Title
Contrast-Enhanced Ultrasound vs Conventional US-guided Percutaneous Needle Biopsy for Pancreatic Diseases: Prospective Multicenter Randomized Controlled Trial
Official Title
Contrast-Enhanced Ultrasound vs Conventional US-guided Percutaneous Needle Biopsy for Pancreatic Diseases: Prospective Multicenter Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
February 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
xiao-yan xie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
The patients with pancreatic diseases who need receive percutaneous biopsy were randomized with 1:1 ratio into undergo CEUS-GB group and conventional US-GB group.The aims include:
Comparison the diagnostic accuracy rate between CEUS and US group. Comparison the diagnostic specificity, sensitivity and complication rate between CEUS and US group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
196 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CEUS-guided core biopsy group
Arm Type
Experimental
Arm Title
US-guided core biopsy group
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Contrast-enhanced ultrasound-guided core biopsy
Intervention Description
Core biopsy was used to collect samples for pancreatic diseases under contrast-enhanced ultrasound-guided.
Intervention Type
Diagnostic Test
Intervention Name(s)
Conventional ultrasound-guided core biopsy
Intervention Description
Core biopsy was used to collect samples for pancreatic diseases under conventional ultrasound-guided.
Primary Outcome Measure Information:
Title
Diagnostic accuracy rate
Description
Diagnostic accuracy rate was defined as the proportion of patients who reached successful diagnosis
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
The investigator considers that there are any other factors that may be inappropriate for inclusion or affect the subject's participation in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoyan Xie, M.D.
Phone
86-20-87765183
Email
xiexyan@mail.sysu.edu.cn
Facility Information:
Facility Name
Fujian Provincial Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Songsong Wu, M.D.
Phone
0591-88217813
Email
wu_songsong@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Contrast-Enhanced Ultrasound vs Conventional US-guided Percutaneous Needle Biopsy for Pancreatic Diseases: Prospective Multicenter Randomized Controlled Trial
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