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

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Lesions
• Intervention / Treatment: Procedure: CEUS or Contrast enhanced Ultrasound; Procedure: US

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 Type: Observational
• Enrollment (Actual): 330

Contacts and Locations

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361000
      • Department of Ultrasound, The First Affiliated Hospital of Xiamen University, 55 Zhenhai Road, Xiamen, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients underwent CEUS-guided or conventional US-guided coaxial biopsy for focal hepatic lesions.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CEUS Group; CEUS-guided coaxial biopsy for hepatic lesions	Procedure: CEUS or Contrast enhanced Ultrasound; CEUS-guided coaxial biopsy for hepatic lesions
US Group; US-guided coaxial biopsy for hepatic lesions	Procedure: US; US-guided coaxial biopsy for hepatic lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the biopsy success rate	the biopsy success rate of liver lesion	from enrollment to the end of the biopsy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	during the procedure
bleeding	bleeding due to biopsy	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.	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.	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.	48 hours after the surgery
death	Death is the permanent and irreversible end of all life functions in a living organism.	48 hours after the surgery

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Xiamen University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): May 31, 2025
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 22, 2025
• First Posted (Estimated): November 25, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Liver Biopsy; Contrast-enhanced Ultrasound; Focal Liver Lesion; Coarse Needle Biopsy; Coaxial Biopsy
• Other Study ID Numbers: XMFHIIT-2025SL218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No