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

Not Applicable

Not yet recruiting

• Conditions: Pancreatic Disease
• Interventions: Diagnostic Test: Conventional ultrasound-guided core biopsy; Diagnostic Test: Contrast-enhanced ultrasound-guided core biopsy

• Registration Number: NCT05743972
• Lead Sponsor: xiao-yan xie

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.

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-15
• Study First Submitted QC: 2023-02-15
• Last Update Submitted: 2023-02-15
• Study First Posted: 2023-02-24
• Last Update Posted: 2023-02-24
• Study Start: 2023-03-01
• Primary Completion: 2025-12-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 196

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
US-guided core biopsy group	Conventional ultrasound-guided core biopsy	-
CEUS-guided core biopsy group	Contrast-enhanced ultrasound-guided core biopsy	-

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy rate	6 month	Diagnostic accuracy rate was defined as the proportion of patients who reached successful diagnosis

Trial Locations

Locations (1)

Fujian Provincial Hospital; 🇨🇳 Fuzhou, Fujian, China