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Comparative Diagnostic Yield of Contrast-Enhanced Versus Conventional Ultrasound Guidance for Coaxial Biopsy of Hepatic Lesions

Comparative Diagnostic Yield of Contrast-Enhanced Versus Conventional Ultrasound Guidance for Coaxial Biopsy of Hepatic Lesions: A Propensity Score-Matched Analysis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07249268
Enrollment
330
Registered
2025-11-25
Start date
2022-01-01
Completion date
2025-05-31
Last updated
2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Lesions

Keywords

Liver Biopsy, Focal Liver Lesion, Coarse Needle Biopsy, Contrast-enhanced Ultrasound, Coaxial Biopsy

Brief 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. 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.

Interventions

CEUS-guided coaxial biopsy for hepatic lesions

PROCEDUREUS

US-guided coaxial biopsy for hepatic lesions

Sponsors

The First Affiliated Hospital of Xiamen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Indeterminate liver lesions on prior imaging (CT/MRI). * Coaxial biopsy performed with 18G introducer needle.

Exclusion criteria

* Coagulopathy (INR \>1.5, platelets \<50×109/L). * Contraindications to ultrasound contrast agents.

Design outcomes

Primary

MeasureTime frameDescription
the biopsy success ratefrom enrollment to the end of the biopsythe biopsy success rate of liver lesion

Secondary

MeasureTime frameDescription
bleedingduring the procedurebleeding due to biopsy
pneumothoraxduring the procedureA pneumothorax (often called a collapsed lung) happens when air leaks into the space between your lung and your chest wall.
vasovagal reactionduring the procedureA 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.
unplanned hospitalization48 hours after the surgeryAn 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.
death48 hours after the surgeryDeath is the permanent and irreversible end of all life functions in a living organism.
shockduring the procedureShock 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026