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

xiao-yan xie

Status

Not yet enrolling

Conditions

Pancreatic Disease

Treatments

Diagnostic Test: Conventional ultrasound-guided core biopsy

Diagnostic Test: Contrast-enhanced ultrasound-guided core biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT05743972

BZhuang

Details and patient eligibility

About

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.

Full 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.

Enrollment

196 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.