Pancreatic DiseaseNCT05743972
Contrast-Enhanced Ultrasound vs Conventional US-guided Percutaneous Needle Biopsy for Pancreatic Diseases: Prospective Multicenter Randomized Controlled Trial
A study testing Contrast-enhanced ultrasound-guided core biopsy and Conventional ultrasound-guided core biopsy in people with Pancreatic Disease, run by xiao-yan xie at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Disease
- What is being tested?
- Contrast-enhanced ultrasound-guided core biopsy and Conventional ultrasound-guided core biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Routine blood test: Hb≥80 g/L; PLT≥50×109/L;
- Coagulation function test: PT<20s.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Fujian Provincial Hospital
Fuzhou, Fujian, 350000
Songsong Wu, M.D., 0591-88217813, wu_songsong@126.com
About this study
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.
Read the 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.
- Conditions
- Pancreatic Disease
- Being tested
- Contrast-enhanced ultrasound-guided core biopsy, Conventional ultrasound-guided core biopsy
- Medical subject headings
- Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced ultrasound-guided core biopsyDiagnostic test
Core biopsy was used to collect samples for pancreatic diseases under contrast-enhanced ultrasound-guided.
Conventional ultrasound-guided core biopsyDiagnostic test
Core biopsy was used to collect samples for pancreatic diseases under conventional ultrasound-guided.
| Study group | Role | What they receive |
|---|---|---|
| CEUS-guided core biopsy group | Experimental | Not described Receives: Diagnostic Test: Contrast-enhanced ultrasound-guided core biopsy |
| US-guided core biopsy group | Active comparator | Not described Receives: Diagnostic Test: Conventional ultrasound-guided core biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy rate
Diagnostic accuracy rate was defined as the proportion of patients who reached successful diagnosis
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start1 Mar 2023 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- xiao-yan xie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, xiao-yan xie, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743972
- Sponsor's protocol ID
- BZhuang
- Status last verified
- Feb 2023
- First submitted
- 15 Feb 2023
- Last updated
- 24 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-Enhanced Ultrasound vs Conventional US-guided Percutaneous Needle Biopsy for Pancreatic Diseases: Prospective Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05743972
- Acronym / sponsor ID
- BZhuang
- Conditions
- Pancreatic Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- xiao-yan xieUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CEUS-guided core biopsy group | Experimental | Diagnostic Test: Contrast-enhanced ultrasound-guided core biopsy |
| US-guided core biopsy group | Active comparator | Diagnostic Test: Conventional ultrasound-guided core biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast-enhanced ultrasound-guided core biopsyCore biopsy was used to collect samples for pancreatic diseases under contrast-enhanced ultrasound-guided. | Diagnostic test | CEUS-guided core biopsy group |
| Conventional ultrasound-guided core biopsyCore biopsy was used to collect samples for pancreatic diseases under conventional ultrasound-guided. | Diagnostic test | US-guided core biopsy group |
Primary outcome
Diagnostic accuracy rate
Time frame: 6 month
Diagnostic accuracy rate was defined as the proportion of patients who reached successful diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast-enhanced ultrasound-guided core biopsy and Conventional ultrasound-guided core biopsy in people with Pancreatic Disease, run by xiao-yan xie at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyan Xie, M.D. (86-20-87765183, xiexyan@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy rate (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.