Contrast-Enhanced Ultrasound vs Conventional US-guided Percutaneous Needle Biopsy for Pancreatic Diseases: Prospective Multicenter Randomized Controlled Trial
NCT ID: NCT05743972
Last Updated: 2023-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
196 participants
INTERVENTIONAL
2023-03-01
2026-02-01
Brief Summary
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Detailed Description
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Comparison the diagnostic accuracy rate between CEUS and US group. Comparison the diagnostic specificity, sensitivity and complication rate between CEUS and US group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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CEUS-guided core biopsy group
Contrast-enhanced ultrasound-guided core biopsy
Core biopsy was used to collect samples for pancreatic diseases under contrast-enhanced ultrasound-guided.
US-guided core biopsy group
Conventional ultrasound-guided core biopsy
Core biopsy was used to collect samples for pancreatic diseases under conventional ultrasound-guided.
Interventions
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Contrast-enhanced ultrasound-guided core biopsy
Core biopsy was used to collect samples for pancreatic diseases under contrast-enhanced ultrasound-guided.
Conventional ultrasound-guided core biopsy
Core biopsy was used to collect samples for pancreatic diseases under conventional ultrasound-guided.
Eligibility Criteria
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Inclusion Criteria
* 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:
1. Routine blood test: Hb≥80 g/L; PLT≥50×109/L;
2. Coagulation function test: PT\<20s.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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xiao-yan xie
OTHER
Responsible Party
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xiao-yan xie
M.D.
Locations
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Fujian Provincial Hospital
Fuzhou, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BZhuang
Identifier Type: -
Identifier Source: org_study_id
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