Hepatic LesionsNCT07249268
Comparative Diagnostic Yield of Contrast-Enhanced Versus Conventional Ultrasound Guidance for Coaxial Biopsy of Hepatic Lesions
An observational study of Hepatic Lesions, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
This study compared two methods used to guide needle biopsies of suspicious lumps (lesions) in the liver. A biopsy is a procedure where a small sample of tissue is taken to make a diagnosis. Doctors often use standard ultrasound (US) to see the lesion and guide the needle. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatic Lesions
- What is being tested?
- CEUS or Contrast enhanced Ultrasound and US
- Type of treatment
- Surgery or procedure
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 May 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients underwent CEUS-guided or conventional US-guided coaxial biopsy for focal hepatic lesions.
Who may be able to join
- Indeterminate liver lesions on prior imaging (CT/MRI).
- Coaxial biopsy performed with 18G introducer needle.
Who cannot join
- Coagulopathy (INR >1.5, platelets <50×109/L).
- Contraindications to ultrasound contrast agents.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Ultrasound, The First Affiliated Hospital of Xiamen University, 55 Zhenhai Road, Xiamen, China
Xiamen, Fujian, 361000
About this study
Official title: Comparative Diagnostic Yield of Contrast-Enhanced Versus Conventional Ultrasound Guidance for Coaxial Biopsy of Hepatic Lesions: A Propensity Score-Matched Analysis
This study compared two methods used to guide needle biopsies of suspicious lumps (lesions) in the liver. A biopsy is a procedure where a small sample of tissue is taken to make a diagnosis. Doctors often use standard ultrasound (US) to see the lesion and guide the needle. Another method uses a special dye (contrast agent) injected into a vein during the ultrasound, which is called contrast-enhanced ultrasound (CEUS). The dye helps blood vessels and the lesion "light up" on the screen. The researchers wanted to find out if using CEUS leads to a more successful biopsy than using standard US alone.
Read the detailed description
This study compared two different methods used to guide needles during a percutaneous (through the skin) biopsy of a focal liver lesion (a suspicious mass or lump in the liver). The goal was to see if one method was better than the other at ensuring a successful and diagnostic biopsy.
The researchers looked back at the records of 330 patients who had a liver biopsy. Of these, 113 had a CEUS-guided biopsy and 217 had a standard US-guided biopsy. To ensure a fair comparison, they used a statistical method to create two perfectly matched groups of 92 patients each. The patients in these groups were very similar in terms of factors like the size and location of their liver lesion, so that the only major difference was the type of guidance used (CEUS or US).
For most patients with a liver lesion that can be seen on a standard ultrasound, this study suggests that using the more advanced and expensive CEUS method does not increase the chances of a successful biopsy. The standard ultrasound guidance is just as effective.
Therefore, the routine use of CEUS for all liver biopsies may not be necessary. This helps in managing healthcare resources wisely. However, CEUS remains a valuable tool for specific situations where a lesion is very difficult to see clearly on a standard ultrasound scan. Doctors can reserve CEUS for these more challenging cases.
- Conditions
- Hepatic Lesions
- Being tested
- CEUS or Contrast enhanced Ultrasound, US
- Keywords
- Liver Biopsy, Focal Liver Lesion, Coarse Needle Biopsy, Contrast-enhanced Ultrasound, Coaxial Biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEUS or Contrast enhanced UltrasoundProcedure or surgery
CEUS-guided coaxial biopsy for hepatic lesions
USProcedure or surgery
US-guided coaxial biopsy for hepatic lesions
| Study group | Role | What they receive |
|---|---|---|
| CEUS Group | CEUS-guided coaxial biopsy for hepatic lesions Receives: Procedure: CEUS or Contrast enhanced Ultrasound | |
| US Group | US-guided coaxial biopsy for hepatic lesions Receives: Procedure: US |
What is being measured
The primary outcome is the main question the study is designed to answer.
the biopsy success rate
the biopsy success rate of liver lesion
Measured: from enrollment to the end of the biopsy
Secondary outcomes (6)
vasovagal reaction
A vasovagal reaction is a sudden drop in your heart rate and blood pressure. This reduces blood flow to your brain, which can cause you to feel dizzy, sweaty, and nauseous, and can sometimes lead to fainting.
Measured: during the procedure
bleeding
bleeding due to biopsy
Measured: during the procedure
pneumothorax
A pneumothorax (often called a collapsed lung) happens when air leaks into the space between your lung and your chest wall.
Measured: during the procedure
shock
Shock is a critical state of circulatory failure where the body's organs are starved of oxygen due to low blood flow, which can be caused by severe bleeding, heart failure, major infection, or a severe allergic reaction.
Measured: during the procedure
unplanned hospitalization
An unplanned hospitalization is an urgent admission to a hospital, typically through the emergency department, for an unexpected and serious medical event or a sudden worsening of a pre-existing condition.
Measured: 48 hours after the surgery
death
Death is the permanent and irreversible end of all life functions in a living organism.
Measured: 48 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Jan 2022
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic LesionsStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lijuan Yan, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249268
- Sponsor's protocol ID
- XMFHIIT-2025SL218
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- 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 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Diagnostic Yield of Contrast-Enhanced Versus Conventional Ultrasound Guidance for Coaxial Biopsy of Hepatic Lesions: A Propensity Score-Matched Analysis
- ClinicalTrials.gov ID
- NCT07249268
- Acronym / sponsor ID
- XMFHIIT-2025SL218
- Conditions
- Hepatic Lesions
- Keywords
- Liver Biopsy, Focal Liver Lesion, Coarse Needle Biopsy, Contrast-enhanced Ultrasound, Coaxial Biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 25 Nov 2025 (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.
This study compared two methods used to guide needle biopsies of suspicious lumps (lesions) in the liver. A biopsy is a procedure where a small sample of tissue is taken to make a diagnosis. Doctors often use standard ultrasound (US) to see the lesion and guide the needle. Another method uses a special dye (contrast agent) injected into a vein during the ultrasound, which is called contrast-enhanced ultrasound (CEUS). The dye helps blood vessels and the lesion "light up" on the screen. The researchers wanted to find out if using CEUS leads to a more successful biopsy than using standard US alone.
Detailed description
This study compared two different methods used to guide needles during a percutaneous (through the skin) biopsy of a focal liver lesion (a suspicious mass or lump in the liver). The goal was to see if one method was better than the other at ensuring a successful and diagnostic biopsy.
The researchers looked back at the records of 330 patients who had a liver biopsy. Of these, 113 had a CEUS-guided biopsy and 217 had a standard US-guided biopsy. To ensure a fair comparison, they used a statistical method to create two perfectly matched groups of 92 patients each. The patients in these groups were very similar in terms of factors like the size and location of their liver lesion, so that the only major difference was the type of guidance used (CEUS or US).
For most patients with a liver lesion that can be seen on a standard ultrasound, this study suggests that using the more advanced and expensive CEUS method does not increase the chances of a successful biopsy. The standard ultrasound guidance is just as effective.
Therefore, the routine use of CEUS for all liver biopsies may not be necessary. This helps in managing healthcare resources wisely. However, CEUS remains a valuable tool for specific situations where a lesion is very difficult to see clearly on a standard ultrasound scan. Doctors can reserve CEUS for these more challenging cases.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CEUS Group | – | Procedure: CEUS or Contrast enhanced UltrasoundCEUS-guided coaxial biopsy for hepatic lesions |
| US Group | – | Procedure: USUS-guided coaxial biopsy for hepatic lesions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients underwent CEUS-guided or conventional US-guided coaxial biopsy for focal hepatic lesions.
Key inclusion criteria (2 listed)
- Indeterminate liver lesions on prior imaging (CT/MRI).
- Coaxial biopsy performed with 18G introducer needle.
Key exclusion criteria (2 listed)
- Coagulopathy (INR >1.5, platelets <50×109/L).
- Contraindications to ultrasound contrast agents.
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 |
|---|---|---|
| CEUS or Contrast enhanced UltrasoundCEUS-guided coaxial biopsy for hepatic lesions | Procedure or surgery | CEUS Group |
| USUS-guided coaxial biopsy for hepatic lesions | Procedure or surgery | US Group |
Primary outcome
the biopsy success rate
Time frame: from enrollment to the end of the biopsy
the biopsy success rate of liver lesion
6 secondary outcomes
vasovagal reaction
Time frame: during the procedure
bleeding
Time frame: during the procedure
pneumothorax
Time frame: during the procedure
shock
Time frame: during the procedure
unplanned hospitalization
Time frame: 48 hours after the surgery
death
Time frame: 48 hours after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Lesions, run by The First Affiliated Hospital of Xiamen University 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 9 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the biopsy success rate (time frame: from enrollment to the end of the biopsy). 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 9 Dec 2025.