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

Pancreatic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05743972
• Other study ID #: BZhuang
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: February 2023
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Xiaoyan Xie, M.D.
• Phone: 86-20-87765183
• Email: xiexyan[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 196
• Est. completion date: February 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Disease
• Pancreatic Diseases

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
China	Fujian Provincial Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
xiao-yan xie

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy rate	Diagnostic accuracy rate was defined as the proportion of patients who reached successful diagnosis	6 month