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

NCT ID: NCT05743972

Last Updated: 2023-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2026-02-01

Brief Summary

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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

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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.

Conditions

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Pancreatic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CEUS-guided core biopsy group

Group Type EXPERIMENTAL

Contrast-enhanced ultrasound-guided core biopsy

Intervention Type DIAGNOSTIC_TEST

Core biopsy was used to collect samples for pancreatic diseases under contrast-enhanced ultrasound-guided.

US-guided core biopsy group

Group Type ACTIVE_COMPARATOR

Conventional ultrasound-guided core biopsy

Intervention Type DIAGNOSTIC_TEST

Core biopsy was used to collect samples for pancreatic diseases under conventional ultrasound-guided.

Interventions

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Contrast-enhanced ultrasound-guided core biopsy

Core biopsy was used to collect samples for pancreatic diseases under contrast-enhanced ultrasound-guided.

Intervention Type DIAGNOSTIC_TEST

Conventional ultrasound-guided core biopsy

Core biopsy was used to collect samples for pancreatic diseases under conventional ultrasound-guided.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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xiao-yan xie

OTHER

Sponsor Role lead

Responsible Party

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xiao-yan xie

M.D.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Fujian Provincial Hospital

Fuzhou, Fujian, China

Site Status

Countries

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China

Central Contacts

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Xiaoyan Xie, M.D.

Role: CONTACT

86-20-87765183

Facility Contacts

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Songsong Wu, M.D.

Role: primary

0591-88217813

Other Identifiers

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BZhuang

Identifier Type: -

Identifier Source: org_study_id

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