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Completed

NCT Number: NCT07249268

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

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Xiamen, Fujian, 361000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CEUS or Contrast enhanced Ultrasound

Procedure

CEUS-guided coaxial biopsy for hepatic lesions

US

Procedure

US-guided coaxial biopsy for hepatic lesions

Primary outcomes

  1. the biopsy success rate

    Time frame: from enrollment to the end of the biopsy

    the biopsy success rate of liver lesion

Secondary outcomes

  1. vasovagal reaction

    Time frame: during the procedure

    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.

  2. bleeding

    Time frame: during the procedure

    bleeding due to biopsy

  3. pneumothorax

    Time frame: during the procedure

    A pneumothorax (often called a collapsed lung) happens when air leaks into the space between your lung and your chest wall.

  4. shock

    Time frame: during the procedure

    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.

  5. unplanned hospitalization

    Time frame: 48 hours after the surgery

    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.

  6. death

    Time frame: 48 hours after the surgery

    Death is the permanent and irreversible end of all life functions in a living organism.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xiamen University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.