Contrast-Enhanced Ultrasound vs Conventional US-guided Percutaneous Needle Biopsy for Pancreatic Diseases: Prospective Multicenter Randomized Controlled Trial

Study Overview
=================
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.

Official Title
-----------------
Contrast-Enhanced Ultrasound vs Conventional US-guided Percutaneous Needle Biopsy for Pancreatic Diseases: Prospective Multicenter Randomized Controlled Trial

Conditions
-----------------
Pancreatic Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Contrast-enhanced ultrasound-guided core biopsy
* Diagnostic Test: Conventional ultrasound-guided core biopsy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CEUS-guided core biopsy group<br> | Diagnostic Test: Contrast-enhanced ultrasound-guided core biopsy<br>* Core biopsy was used to collect samples for pancreatic diseases under contrast-enhanced ultrasound-guided.<br>|
| Active Comparator: US-guided core biopsy group<br> | Diagnostic Test: Conventional ultrasound-guided core biopsy<br>* Core biopsy was used to collect samples for pancreatic diseases under conventional ultrasound-guided.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy rate | Diagnostic accuracy rate was defined as the proportion of patients who reached successful diagnosis | 6 month |