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

Sponsor
xiao-yan xie (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05743972
Collaborator
(none)
196
Enrollment
1
Location
2
Arms
35.1
Anticipated Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Contrast-enhanced ultrasound-guided core biopsy
  • Diagnostic Test: Conventional ultrasound-guided core biopsy
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
196 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Diagnostic
Official Title:
Contrast-Enhanced Ultrasound vs Conventional US-guided Percutaneous Needle Biopsy for Pancreatic Diseases: Prospective Multicenter Randomized Controlled Trial
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: CEUS-guided core biopsy group

Diagnostic Test: Contrast-enhanced ultrasound-guided core biopsy
Core biopsy was used to collect samples for pancreatic diseases under contrast-enhanced ultrasound-guided.
Active Comparator: US-guided core biopsy group

Diagnostic Test: Conventional ultrasound-guided core biopsy
Core biopsy was used to collect samples for pancreatic diseases under conventional ultrasound-guided.

Outcome Measures

Primary Outcome Measures

  1. Diagnostic accuracy rate [6 month]

    Diagnostic accuracy rate was defined as the proportion of patients who reached successful diagnosis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fujian Provincial Hospital Fuzhou Fujian China 350000

Sponsors and Collaborators

  • xiao-yan xie

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
xiao-yan xie, M.D., First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT05743972
Other Study ID Numbers:
  • BZhuang
First Posted:
Feb 24, 2023
Last Update Posted:
Feb 24, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pancreatic Diseases

Study Results

No Results Posted as of Feb 24, 2023