Skip to main content
Clinical Trials/NCT07249268
NCT07249268CompletedNot Applicable

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

The First Affiliated Hospital of Xiamen University1 site in 1 country330 target enrollmentStarted: January 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
330
Locations
1
Primary Endpoint
the biopsy success rate

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts 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.

Outcomes

Primary Outcomes

the biopsy success rate

Time Frame: from enrollment to the end of the biopsy

the biopsy success rate of liver lesion

Secondary Outcomes

  • vasovagal reaction(during the procedure)
  • bleeding(during the procedure)
  • pneumothorax(during the procedure)
  • shock(during the procedure)
  • unplanned hospitalization(48 hours after the surgery)
  • death(48 hours after the surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lijuan Yan

Principal Investigator

The First Affiliated Hospital of Xiamen University

Study Sites (1)

Loading locations...

Similar Trials