Pancreatic Disease
Conditions
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.
Interventions
DIAGNOSTIC_TESTContrast-enhanced ultrasound-guided core biopsy
Core biopsy was used to collect samples for pancreatic diseases under contrast-enhanced ultrasound-guided.
DIAGNOSTIC_TESTConventional ultrasound-guided core biopsy
Core biopsy was used to collect samples for pancreatic diseases under conventional ultrasound-guided.
Sponsors
xiao-yan xie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. Routine blood test: Hb≥80 g/L; PLT≥50×109/L; 2. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy rate | 6 month | Diagnostic accuracy rate was defined as the proportion of patients who reached successful diagnosis |
Countries
China
Contacts
Primary ContactXiaoyan Xie, M.D.
Outcome results
None listed